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  • / June 2019
  • / Managing Dry Eye Disease, Case by Case

Managing Dry Eye Disease, Case by Case

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When it comes to treating dry eye disease (DED), some ophthalmologists may be skeptical of the hype surrounding the latest drugs and devices to hit the mar­ket. They caution that until there is a better understanding of DED’s underly­ing mechanisms, therapeutic and diagnostic breakthroughs may remain elusive.

Still, ophthalmologists with an interest in dry eye have reasons for optimism. Dry eye experts are noting incremental advances in diagnosis and treatment in their daily practices. “From my perspective, there have been major improvements already,” said Elisabeth M. Messmer, MD, at Ludwig-Maximilian University of Munich in Germany.

Update on Therapies

Innovations. According to Dr. Messmer, today’s artificial tears include ingredients that enable them to remain longer on the ocular surface. These include compatible solutes (osmoprotectants), lipids, and molecules that work as secretagogues. Even more import­ant, artificial tears without the toxic preservative benzalkonium chloride are now readily available, she said.

Penny Asbell, MD, at the University of Tennessee Health Science Center in Memphis, reported that new molecules to replace missing elements in the tears, such as proteogly­cans, and novel antioxidative drugs, such as SkQ1, are coming down the pike. In particular, Giacomina Massaro-Giordano, MD, at the University of Pennsylvania in Philadelphia, is excited about a glycoprotein lubricant called lubricin, which is different from carboxymeth­ylcellulose and all previous lubricants. She is also optimistic about a synthetic form of lacri­tin—a protein that is selectively deficient in dry eye tears and stimulates tear secretion and corneal epithelial renewal. In addition, nerve growth factor drops (cenegermin, Oxervate), recently FDA approved for neurotrophic keratitis, may help a subset of dry eye patients.

Anti-inflammatories. Anti-inflammatory drugs on the market include cyclosporine A (Restasis, CSA 0.05% in the United States; Ikervis, 0.1% in Europe) and lifitegrast (Xiidra). There is a role for these medications, though the benefits depend on careful patient selec­tion, according to Sonal S. Tuli, MD, MEd, at the University of Florida in Gainesville. For starters, most patients with inflamed eyes cannot tolerate the drops. “To make cyclosporine into an emulsion, you have to make it a little acidic,” Dr. Tuli explained. “It can feel like putting lemon juice on a wound.” To help patients tolerate Restasis or Xiidra, most clinicians first prescribe steroids to calm the eye, according to Joanne F. Shen, MD, at Mayo Clinic in Arizona, who is not a fan of the so-called Lotemax-to-Restasis bridge. “Once patients start on steroids, they don’t want to come off. Many patients will need cataract surgery earlier than would have been expected [because the steroid can cause cataract forma­tion],” she cautioned.

Dr. Tuli sometimes opts to bridge a patient to Restasis with a milder steroid for a week, but she insists on a strict, rapid taper. Both Drs. Tuli and Shen are proponents of doxycycline and often choose to skip the Restasis- or Xiidra-plus-steroid approach.

Newer formulations of cyclosporine (e.g., the combination of cyclosporine with semifluorinated alkanes to improve bioavailability) are in the study pipeline, according to Drs. Messmer and Asbell; results are expected soon. One new nanotechnol­ogy formulation, a nanomicellar formulation of cyclosporine A (0.09%) called Cequa was FDA approved in 2018 but is not yet commercially available. Generic versions of CSA were expected to enter the U.S. market last year but have been delayed, said Dr. Tuli.

Devices. Mechanical options are also available to treat meibomian gland dysfunction (MGD), including LipiFlow and intense pulsed light (IPL). An intranasal neurostimulator, TrueTear, is now sold over the counter. Despite the hefty price tag for the latter, Dr. Tuli said that some patients really like it. However, why or how long it will continue to have a sustained effect after its use is discontin­ued is still unknown, she said.

Diagnostic Considerations

Diagnostic tools. Today, diagnostic tools to detect inflammation (e.g., biomarkers like MMP-9) and corneal innervation are recognized as import­ant for individualizing treatment. Dr. Asbell is most excited about the potential for minimally invasive objective metrics. “The development of well-validated biomarkers would allow us to more specifically categorize DED problems and tailor our treatments accordingly,” she said.

Diagnosis is paramount. Often, the takeaway from expert discussions about DED is to spend time performing an exhaustive examination to pin down the cause of dry eye. Therapies can differ completely, depending on whether the etiology lies in the tear film, anatomy, or nervous sys­tem—or in a combination of these. Moreover, the cause can have an impact on how aggressive your approach might be. For example, when Dr. Tuli sees patients with Sjögren syndrome, a progressive autoimmune process that will continue to damage their tear glands, she starts them on one of the prescription drugs right away, even if the patient doesn’t have symptoms. But she wouldn’t be so aggressive for a patient with dry eye induced by computer use.

Make the time for workup. According to Dr. Shen, it’s extremely difficult in most practices to find the time needed to rule out everything that could be masquerading as dry eye or contributing to it. Dr. Massaro-Giordano agreed and empha­sized the importance of conjunctival staining, especially with lissamine green. Dr. Messmer added, “With a drop of fluorescein, you can judge three important things at the same time to estab­lish a dry eye diagnosis: 1) the tear film meniscus, 2) tear film break-up time [TBUT], and 3) ocular surface damage.”

Make time for patient interaction. The experts advise ophthalmologists to set aside adequate time for dry eye patients. “Show your patients some love,” said Dr. Asbell. “Listen to them carefully and see them regularly if they’re very symptom­atic.” Dr. Messmer added, “Take your patients’ complaints seriously. Some may complain of visual disturbances although they have full vision on conventional vision testing. This is due to a decrease in functional visual acuity.”

Looking Ahead

Some ophthalmologists have developed a healthy level of skepticism about new products. But, said Dr. Massaro-Giordano, given the vast number of DED patients and the many therapies in devel­opment to address different mechanisms and symptoms, it’s important for ophthalmologists to keep a keen eye on the pipeline and an open mind.

“It’s hard to say why some things work for dry eye,” said Dr. Massaro-Giordano, “They just do. Over 25 years, I’ve seen it clinically, though sometimes it’s hard to pinpoint the science behind it.” For those waiting for evidence on whys and hows of various treatments, she said, “The science is coming!”

Case Studies

The cases on the next few pages help elucidate the diagnostic process and therapeutic approach­es—often combining newer therapies with the trusted standbys—followed by experts in the field. The key messages are recognizing that DED is a multifactorial process, tailoring treatment to the particulars of the individual case, and being pre­pared to escalate to more intensive therapy when response is inadequate.

CASE 1: Neuropathic Ocular Pain, or “Pain Without Stain”

A 55-year-old woman presents with symptoms of “burning” eye discomfort, light sensitivity, and occasional pain that has been recalcitrant to aggressive lubrication and topical steroids. Visual acuity (VA) with spectacle correction is 20/20 in both eyes. There is mild MGD in both sets of eyelids, but the rest of the ocular and eyelid examination is within normal limits. Schirmer testing is 7 mm bilaterally.

DR. SHEN. I follow a variation of the DEWS II diagnosis and treatment algorithm. In my EHR, I have added a list of questions to ask about symp­toms of nocturnal lagophthalmos (dry eye worse upon awakening in the morning) and to rule out other types of ocular surface disease (OSD; e.g., autoimmune diseases such as graft-vs.-host disease or rosacea, lagophthalmos, and recurrent or past severe eye infection) or mechanical reasons for poor blink function (e.g., Parkinson disease, cosmetic surgery, or use of Botox or fillers).

This patient has an Ocular Surface Disease Index (OSDI) score of 66, so I have a baseline to compare to future visits. Neither fluorescein nor lissamine green stain reveals any significant findings on the cornea or conjunctiva. With a thorough slit-lamp exam, I always evert the eyelids to look for other OSD culprits. This patient shows no staining, foreign bodies, concretions, scarring, or papillary or follicular conjunctivitis. To check IOP, I have the technician use an iCare tonometer to avoid instilling anesthetic that could affect the staining. Bilateral corneal sensation is confirmed by touching the cornea with a wisp of cotton. After I place topical anesthetic, the eye discomfort improves only 50% in both eyes.

With no ocular surface findings and severe burning pain symptoms, along with incomplete relief of pain with topical anesthetic, the DEWS II diagnostic algorithm indicates that the patient has either “symptoms without signs” or “neuropathic pain.” I follow the staged treatment steps outlined in DEWS II. (See below .)

The patient’s MGD is very common and is not a likely cause of her symptoms. Since it is easy, cheap, and low risk, I advise Step 1 treatment. I would also talk to the patient about neuropathic eye pain and how it differs from DED, reassuring her that, fortunately, I don’t see severe damage on the clinical exam. If there is access to laser in vivo confocal microscopy, corneal subepithelial nerve plexus imaging would likely show micro­neuromas, decreased nerve density, and increased tortuosity. 1

I would also try DEWS II Step 2 therapy, low-dose topical steroids and punctal plugs, if the tear meniscus is low and there is no history of reflex tearing.

If plugs plus steroids did not help, I would then consider the following measures: autologous serum tears (AST) 20% every two hours for six months with low-dose steroids (I try to defer use of AST because of their out-of-pocket expense) and future placement of Prokera (biotissue); pain medications and referral to a pain specialist for the neuropathic eye pain; an FL41 filter (in case of light sensitivity) or moisture chambers; and lastly scleral lenses.

DR. MASSARO-GIORDANO. Neuropathic ocular pain has confounded ophthalmologists for many years. Many patients with neuropathic pain are dismissed by their doctors when, in fact, they are some of the most devastated patients and they need special care.

In addition to Dr. Shen’s list of medications to consider, I might add low-dose oral naltrexone 2 mg, an opioid antagonist. 1 I would also note that, in my clinical experience, scleral lenses do not work as well if the pain has become centralized.

CASE 2: Exposure Keratopathy

An 89-year-old man with primary open-angle glaucoma presents with unilateral eye pain, redness, and fluctuating vision in the right eye. The other eye is not symptomatic. VA is 20/60 in the right eye and 20/25 in the left. He has had a trabeculectomy in the symptomatic eye. He uses a prostaglandin analogue and an alpha agonist in both eyes. Examination reveals mild generalized conjunctival injection, an elevated superior bleb without localized injection, and diffuse inferior corneal staining in the right eye. The elevated bleb causes incomplete eyelid closure. The left eye has scattered areas of punctate staining throughout the cornea. There is bilateral MGD. Schirmer testing with anesthe­sia is 12 mm in both eyes. TBUT is 6 seconds bilaterally.

DR. TULI. Glaucoma treatment and dry eyes have a well-established relationship, primarily because of toxicity from glaucoma drops. However, ocular surface changes caused by glaucoma surgery are now increasingly recognized. Both trabeculectomy and tube shunt surgery are asso­ciated with an elevated area near the limbus resulting from the filtering bleb or the patch graft over the tube. This elevation can lead to several problems with tear physiology. As with this pa­tient, a high bleb can cause incomplete closure of the eyelid, resulting in exposure keratopathy.

Another reason for ocular surface instability is defective wiper action of the upper lid, leading to inadequate spread of the tear film, stagnation of tears under the bleb, and rapid TBUT ( Fig. 2B ). This dysfunction can also lead to the formation of dellen and filaments under the bleb.

Management of these patients is challenging. Bleb management early in the postoperative period is critical to minimize the risk of a very high and cystic bleb. In addition, patients with trabeculectomy blebs are advised against having procedures that may shorten the upper lid such as blepharoplasty and ptosis surgery.

Plugging the lacrimal canaliculi and having the patient use supplementary tears can increase the tear lake and mitigate the drying of the cornea in the area of exposure keratopathy. Patients are asked to use a lubricating ointment at night, when the exposure is particularly problematic. Mois­ture chamber glasses can help by improving the humidity of the air around the eye.

Filamentary keratitis is managed with debride­ment and hypertonic saline ointment at night or acetylcysteine eyedrops. However, patients with this condition often require surgical management to resolve the OSD. One strategy is to decrease the bleb height with compression sutures ( Fig. 2C ).

DR. MASSARO-GIORDANO. In my experience, switching patients to preservative-free single-use glaucoma drops can make a significant difference. Although these drops are more expensive, and often a prior authorization from the insurance company is required, I recommend making the extra effort.

I agree with telling patients to use lubricat­ing ointment at night, though I prefer gels. If a patient’s eyes do not close, I recommend that they use disposable bubble eye bandages such as NitEye at bedtime.

Also, keep in mind that patients who need surgery might be candidates for microshunt glaucoma devices placed in the eye so there are no surface issues. Finally, be sure to treat the MGD to help the overall tear film.

CASE 3: Stain Without Pain

A 65-year-old man with facial rosacea and rhinophyma presents for routine examination, complaining of progressive reduced vision in both eyes over the last two years. He does not note any foreign body sensation. On exam, VA is 20/60 in both eyes. He has severe rosacea blepharitis with diffuse corneal staining bilat­erally. TBUT is instantaneous in both eyes, and Schirmer testing is 8 mm bilaterally. He also has bilateral 2+ nuclear sclerotic cataracts and is considering cataract surgery.

DR. MASSARO-GIORDANO. Starting with the patient’s history, I ask whether he has a personal or family history of an autoimmune disorder. I ask about dry mouth, sleep apnea and CPAP use, and use of over-the-counter tears with preservatives, which can contribute to corneal staining. I also inquire about current medications, particularly hormonal therapy such as antiandrogens for pros­tate issues, as this can aggravate MGD.

I assess whether his reduced VA is due to surface disease and/or cataract by checking the refraction and seeing if it improves with correc­tion. I look at the degree of rosacea and consider Demodex infestation, checking for debris on the lids and lashes, specifically waxy collarettes. I characterize the degree of telangiectasia and look at the expressible and nonexpressible meibomian secretions and whether the tears appear foamy.

Staining the conjunctiva and lid margins with lissamine green and looking for a widened Marx line are useful steps. I also carefully examine the tear height to rule out tear insufficiency dry eye (e.g., Sjögren syndrome). In addition, I would check corneal sensation; given the diffuse staining, one would expect some degree of symptoms.

Typically, I obtain LipiView images to look at incomplete blinks and thickness of the lipid layer as well as infrared images of the meibomian glands. I do MMP-9 testing as well, though I do not routinely get confocal images of the glands. However, I do obtain confocal images of the cor­nea if I suspect corneal nerve abnormality.

It’s critical to stabilize the tear film and treat inflammation before cataract surgery, even just to get accurate IOL calculations. My approach would start with aggressive lid hygiene. I instruct patients how to safely massage and clean their lids with premoistened pads. If I suspect Demodex, I recommend pads containing tea tree oil. If the patient has difficulty with this regimen, I may recommend LipiFlow and/or IPL treatment. I do recommend preservative-free artificial tears, but not necessarily lipid-containing tears, and a short course of antibiotic/steroid ointment for the eyes and lids. I consider azithromycin drops for the eyes and lids, brimonidine eyedrops (an off-label use currently being studied), and oral doxycycline or azithromycin. Adding a bedtime ointment or gel is helpful. If Demodex is severe, I add ivermec­tin cream or tablets.

I routinely discuss environmental triggers, such as heat, air vents, and fans, and I suggest use of goggles, humidifiers, etc. When outdoors, patients may benefit from wraparound sunglasses, with or without moisture chambers. Blinking exercis­es and appropriate tablet/computer use are also reviewed. If a patient asks about omega-3 fatty acids, I discuss the current evidence. 2

It’s worth noting that rosacea is complicated, and its mechanisms are not clearly understood. There is some debate over whether more telangi­ectasia truly equals worse MGD, and my sense is that there is a correlation. A recent paper used lid injections of bevacizumab for MGD and saw good results with diminished vascularity. 3

CASE 4: Post-LASIK Dry Eye

A healthy 38-year-old man who works as a financial analyst presents with fluctuating vision and foreign body sensation in both eyes. He underwent bilateral myopic LASIK six months ago. He is not using any drops. On exam, uncor­rected VA is 20/25 -1 in both eyes, improving to 20/20 with pinhole. LASIK flaps are unremark­able, but the corneas have moderate epithelial staining bilaterally. Schirmer testing is 6 mm, and TBUT is 8 seconds in both eyes. Corneal topography reveals a well-centered myopic LASIK, but the Placido rings are not crisp.

DR. SHEN. Based on the patient’s surgical history, I am most concerned about relatively neurotrophic post-LASIK dry eye. A refraction is performed to ensure he is not overminused or demonstrating presbyopia, but no glasses should be prescribed until his ocular surface is healed. I follow a vari­ation of the DEWS II diagnosis and treatment algorithm and use a list of questions I keep in my EHR to rule out other OSD or mechanical reasons for poor blink function.

The patient’s OSDI score is 22. Lid eversion shows no staining, foreign bodies, concretions, scarring, or papillary or follicular conjunctivitis. Corneal sensation is markedly decreased in both eyes when tested before instillation of anesthetic. Topical anesthetic improves 100% of the mild foreign body sensation in both eyes.

LipiView I ( Figs. 4A-4D ) and Oculus Kera­tograph5 infrared meibography are performed. LipiView demonstrates a low lipid tear layer, worse in the right eye, and 100% incomplete blinks during the recording (partial blinks, PB). The Keratograph shows some shortening and atrophy of the meibomian glands as well as glands that are engorged with meibum. The patient and I discuss his incomplete blinks and the resulting relative lagophthalmos, compounded by long hours on the computer for his work, with incomplete blink leading to an unstable ocular surface.

Overall, I think the patient is neurotrophic with decreased corneal sensation from LASIK and has MGD compounded by incomplete blinks. It is hard to say why and when the incomplete blinking originated. It is seen commonly in current and previous contact lens wearers.

DEWS II Step 1 treatment for MGD is ini­tiated. I find punctal plug occlusion helpful for incomplete blink and neurotrophic dry eye. The patient may also benefit from LipiFlow (Step 2). Since he is recently post-LASIK, I would recom­mend three-month dissolvable punctal plugs bilaterally in the lower lids, as his neurotrophic problems may improve with time. We would also discuss nighttime lubricating gel or ointment if symptoms are worse upon awakening.

DR. TULI. I completely agree with Dr. Shen’s diag­nosis and management plan. The only difference in my approach is that I am a lot more aggressive with dry eye and MGD treatment, especially post-LASIK. I find that these patients have much more significant visual disturbances and are much more unhappy with their outcomes if they have dry eye. I would add higher-level MGD treatment with doxycycline and Restasis and also recommend longer-acting plugs. Since the patient is still symp­tomatic after six months, it suggests that his issues are likely to be long term. If the above treatments are not sufficient, I would also consider a short course of autologous serum tears or self-retain­ing amniotic membranes in these patients with a neurotrophic component to their dry eye.

CASE 5: Dry Eye Secondary to Sjögren Syndrome

A 54-year-old woman with a 20-year histo­ry of rheumatoid arthritis (RA) is referred by her rheumatologist for evaluation. She notes reduced vision and chronic discomfort bilat­erally. She is currently using preserved artifi­cial tears every hour without relief. She is on disease-modifying therapy for her RA, which is under good control systemically. On exam, VA is 20/40 in both eyes. There is virtually no tear lake. The cornea has diffuse staining with occasional filaments. Schirmer testing is 0 mm. The rest of the exam is unremarkable.

DR. ASBELL. This is classic dry eye disease with severe aqueous deficiency in the setting of a systemic immune-mediated disease, RA. Further examination would include documentation of the degree of OSD. For the cornea, this would entail vital dye testing with fluorescein using a Wratten #12 yellow filter handheld in front of the oculars as you observe the cornea with cobalt blue light to enhance visibility of the staining. For the conjunc­tiva, lissamine green would be used primarily to enable evaluation of response to treatment over time. The HD Analyzer can be helpful to distin­guish between vision loss from OSD and cataract. The former is manifested by wave changes over time, between blinks, and the latter by a wave that is constant between blinks. It is likely that both surface disease and cataracts are contributing to reduced vision in this patient.

Although we have a pretty good idea why patients with Sjögren syndrome have dry eyes—inflammatory effects on the lacrimal gland—it is also good to look for MGD, which can contribute to surface changes and discomfort. It’s important to gently evert the lid to observe the puncta of the meibomian glands and, with slight pressure, look at the meibum: Are the glands obstructed? Is the meibum cloudy or pasty? If MGD is present, treat it in addition to treating the ocular surface direct­ly. Check also for lid lag and exposure.

Unfortunately, with a Schirmer test of 0 mm, it is unlikely that stimulation will increase tears, so my efforts are mainly geared toward replacing the lubrication and keeping it on the eye. That said, I often do try immunomodulators, including top­ical cyclosporine or lifitegrast. Even these severe cases sometimes respond to low-dose topical ste­roid, such as nonpreserved dexamethasone 0.01% drops twice daily (compounded, off-label use). Unfortunately, systemic immunosuppression and/or modulation do not appear to be effective for ocular findings, likely because the lacrimal gland is already too severely damaged to respond.

For lubrication, only nonpreserved treatments are recommended. A thicker consistency, such as gels and ointments, may work better. Compound­ed autologous serum can be helpful, though strong evidence is sparse, and these drops can be costly and require careful attention to hygiene to avoid contamination. Punctal occlusion can be considered and may help keep the lubricants on the ocular surface for longer contact.

If filamentary keratitis is present, filament re­moval at the slit lamp can be a short-term fix and is especially helpful if lubrication is then maxi­mized. Amniotic membrane with a bandage con­tact lens is sometimes useful for severe flare-ups, but it is not practical for this chronic condition. For both symptoms and vision, contact lenses may be needed. Occasionally, a soft bandage lens can help, but more typically scleral lenses, with their reservoir of fluid, are the only way to achieve clinical improvement.

DR. TULI. Sjögren syndrome patients can be very challenging, especially those who have an almost complete absence of aqueous tears. I explain to these patients that even preservative-free artificial tears should not be used every hour, as they can deplete the mucins that act as conditioners of the ocular surface to allow the tears to adhere to the eyes. In severe dry eye patients, secretagogue med­ications such as oral pilocarpine or cevimeline may be helpful—however, they stimulate salivary glands more than lacrimal glands and therefore work better for dry mouth. Finally, I stress the need to use topical cyclosporine chronically, even if patients do not perceive any benefit for their symptoms. The lacrimal gland damage that occurs in Sjögren syndrome is primarily due to lym­phocytic infiltration, and the cyclosporine may mitigate further damage.

___________________________

1 Dieckmann G et al. Ophthalmology . 2017;124(11):S34-S47.

2 Dry Eye Assessment and Management Study Research Group. N Engl J Med. 2018;378:681-1690.

3 Jiang X et al. Drug Des Devel Ther. 2018;12:1269-1279.

Meet the Experts

Penny A. Asbell, MD, FACS Barret G. Haik Endowed Chair of Ophthalmology; director of the Hamilton Eye Institute; and professor of ophthalmology at University of Tennessee Health Science Center in Memphis. Disclosures: Allergan: C; Baus­ch + Lomb: C,S; Contact Lens Association of Ophthalmolo­gists: C; MC2: C,S; Medscape: L; MioTech: C,S; NEI: S; Novar­tis: C,S; Oculus: L; Office of Dietary Supplements-NIH: S; Rtech: C,S; Santen: L; Scientia CME: L; Shire: C; Vindico: L.

Giacomina Massaro-Giordano, MD Codirector of the Penn Dry Eye & Ocular Surface Center; professor of clinical ophthalmology at the Scheie Eye Institute at the University of Pennsylvania in Philadel­phia. Disclosures: Celularity: C; GlaxoSmithKline: C; PRN Physician Recommended Nu­triceuticals: O.

Elisabeth M. Messmer, MD Professor of ophthalmology at the Ludwig-Maximilian Uni­versity of Munich in Germany. Disclosures: Alcon: C,L; Aller­gan: C,L; Dompé: C,L; Santen: C,L; Shire C,L; Sun Pharmaceu­ticals: C; Thea: C,L; TRB-Che­medica: C,L; UrsaPharm: L; Visufarma: C,L.

Joanne F. Shen, MD Assistant professor of ophthalmology, chair of ophthalmology, and director of the Dry Eye Clinic at the Mayo Clinic in Arizona. Disclosures: None.

Sonal S. Tuli, MD, MEd Chair of ophthalmology at the Uni­versity of Florida, Gainesville. Disclosures: None .

See the disclosure key  at  www.aao.org/eyenet/disclosures .

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Digital Eye Strain- A Comprehensive Review

Kirandeep kaur.

1 Aravind Eye Hospital and Post Graduate Institute of Ophthalmology, Pondicherry, 605007 India

Bharat Gurnani

Swatishree nayak.

2 Department of Ophthalmology, AIIMS, Raipur, Chhattisgarh 492001 India

Nilutparna Deori

3 Sri Sankaradeva Nethralaya, Guwahati, Assam 781028 India

Savleen Kaur

4 Advanced Eye Center, Post Graduate Institute of Ophthalmology, Chandigarh, 160012 India

Jitendra Jethani

5 Baroda Children Eye Care and Squint Clinic, Vadodara, Gujarat 390007 India

Digvijay Singh

6 Noble Eye Care, Gurugram, 70058 India

Sumita Agarkar

7 Department of Pediatric Ophthalmology and Adult Strabismus, Sankara Nethralaya, 18 College Road, Chennai, Tamil Nadu 600006 India

Jameel Rizwana Hussaindeen

8 Sankara Nethralaya, 18 College Road, Chennai, Tamil Nadu 600006 India

Jaspreet Sukhija

Deepak mishra.

9 Department of Ophthalmology, Regional Institute of Ophthalmology, Institute of Medical Sciences, Banaras Hindu University, Varanasi, Uttar Pradesh 221005 India

Digital eye strain (DES) is an entity encompassing visual and ocular symptoms arising due to the prolonged use of digital electronic devices. It is characterized by dry eyes, itching, foreign body sensation, watering, blurring of vision, and headache. Non-ocular symptoms associated with eye strain include stiff neck, general fatigue, headache, and backache. A variable prevalence ranging from 5 to 65% has been reported in the pre-COVID-19 era. With lockdown restrictions during the pandemic, outdoor activities were restricted for all age groups, and digital learning became the norm for almost 2 years. While the DES prevalence amongst children alone rose to 50–60%, the symptoms expanded to include recent onset esotropia and vergence abnormalities as part of the DES spectrum. New-onset myopia and increased progression of existing myopia became one of the most significant ocular health complications. Management options for DES include following correct ergonomics like reducing average daily screen time, frequent blinking, improving lighting, minimizing glare, taking regular breaks from the screen, changing focus to distance object intermittently, and following the 20-20-20 rule to reduce eye strain. Innovations in this field include high-resolution screens, inbuilt antireflective coating, matte-finished glass, edge-to-edge displays, and image smoothening graphic effects. Further explorations should focus on recommendations for digital screen optimization, novel spectacle lens technologies, and inbuilt filters to optimize visual comfort. A paradigm shift is required in our understanding of looking at DES from an etiological perspective, so that customized solutions can be explored accordingly. The aim of this review article is to understand the pathophysiology of varied manifestations, predisposing risk factors, varied management options, along with changing patterns of DES prevalence post COVID-19.

Key Summary Points

Introduction.

Technology has transformed every realm of our lives in the information age, from healthcare to education. The digital revolution, or the third industrial revolution, commenced in the 1980s, showing no signs of deceleration. Prompt communication, extensive availability of information, and most imperative, going paperless or GO GREEN are various advantages. However, every action comes with its opposite reaction, and the digital revolution is no deviation from this rule. As outlined by the American Optometric association, digital eye strain encompasses a cluster of ocular and vision-related problems attributed to prolonged usage of desktops, laptops, mobile phones, tablets, e-readers, and storage devices [ 1 ].

The Digital Eye Strain Report of 2016, which included survey responses from over 10,000 adults from the USA, identified an overall self-reported prevalence of 65%, with females more commonly affected than males (69% vs. 60% prevalence) [ 2 ]. Its pathophysiology is multifactorial, with several contributing factors being reduced contrast level of letters compared to the background of digital screens, screen glare and reflections, wrong distance and angle of viewing digital screens, poor lighting conditions, improper posture during usage, and infrequent blinking of eyes [ 3 ]. The eye focusing and ocular movements required for better visibility of digital screen place additional demand on an intricate balance between accommodation and convergence mechanisms, thus making people with uncorrected or under-corrected refractive errors even more susceptible [ 4 ]. The condition can cause an array of symptoms, including eyestrain, watering of eyes, headache, tired eyes, burning sensation, red eyes, irritation, dry eye, foreign body sensation, blurred vision at near, and double vision [ 5 ].

According to the American Optometric Association, the usage of digital devices continuously for two hours is adequate to bring about digital eye strain [ 1 , 6 ]. However, during the recent outbreak of novel Coronavirus disease-19 (COVID-19) declared by World Health Organization, there has been an upsurge in the usage of digital devices. Several countries worldwide declared a nationwide lockdown to shut down activities that necessitate human assembly and interactions, including educational institutions, malls, religious places, offices, airports, and railway stations, to contain the spread of the virus [ 7 ]. A major part of the world was compelled to be confined indoors due to the dreaded consequences of this global pandemic, and its effects could be visualized in various sectors. Due to the lockdown, most people resorted to the internet and internet-based services to communicate, interact, and continue with their job responsibilities from home. Working from home became the new norm of working for millions of employees worldwide. Video-conferencing became the new mode of holding meetings and conferences.

Education is yet another domain that witnessed a change in paradigm to the online way of implementation. Online learning services served as a panacea during the pandemic. Video conferencing platforms like Zoom and Google Meet have been used by schools, colleges, and universities worldwide since the beginning of the lockdown. There was a rise in usage of internet services from 40 to 100%, compared to pre-lockdown levels [ 8 ]. Digital payments and digital currencies played a vital role in the pandemic. Being restricted indoors, digital devices became the only source of entertainment. Thus, the COVID-19 pandemic has added even more fuel to the already existing fire of the digital revolution. Ultimately this has resulted in an upsurge in the symptoms of digital eye strain amongst most individuals irrespective of age, sex, race, or region. The objective of this review article is to comprehensively present an overview of digital eye strain, its pathophysiology, management strategies, role of ophthalmologists and visual health specialists in educating parents or patients and also to understand the impact of COVID-19 on DES prevalence. We have also briefly highlighted the future research prospects in the field of DES. This review article is based on previously conducted studies. The article does not contain any studies with human participants or animals performed by any of the authors.

Literature Search

A comprehensive systematic literature search was done using PubMed, Google Scholar, and Cochrane database. The search was done using the terms “digital eye strain” or “computer vision syndrome” or “ocular asthenopia secondary to digital devices” or “eye strain”, or “visual fatigue” or “blue-blocking glasses” on May 15, 2022. All the articles with available abstracts along with the referenced articles until the date of search were evaluated. Original research work in the English language on DES and those mentioning prevalence, risk factors, clinical features were considered for inclusion into the present review article. The final reference list was generated on the basis of original work considered for inclusion relevant to the broad scope of this review article. Studies done before and after the COVID-19 pandemic have been summarized in tabular formats.

Symptoms of DES

Digital eye strain has been used synonymously with ocular asthenopia secondary to digital devices, computer vision syndrome, eye strain post computer or mobile usage, or even visual fatigue [ 3 , 9 – 12 ]. The most common symptom is a sense of eye discomfort. This may be in the form of watering, redness, and itching in the eyes. The patients may complain of dryness in the eyes.

Apart from this, a frequent complaint is blurry vision. The patient typically complains of blur and clear vision episodes, and eye strain. This usually reduces their concentration but improves after rest. Another set of symptoms is that the patient complains of glare, excessive sensitivity to light, and inability to keep the eyes open. All of these may be associated with headaches and occasionally sore neck or back [ 3 , 10 – 13 ].

Broadly, these symptoms can be classified into three categories:

  • Ocular surface-related symptoms are secondary to reduced blink and related to dry eye. These symptoms typically include irritation/burning eyes, dry eyes, eye strain, headache, tired eyes, sensitivity to bright light, and eye discomfort [ 13 , 14 ].
  • Accommodation or vergence-related symptoms are secondary to excessive work and related to anomalies of accommodation or binocular visual system. These symptoms include blurred near or distance vision after computer use, difficulty refocusing from one distance to another, or diplopia [ 13 – 15 ].
  • Extraocular symptoms include musculoskeletal symptoms which can result in inconvenience in daily routine activities. These may include body discomfort like headache, neck or shoulder pain, and back pain [ 16 ].

Now, even myopia progression has been linked to the digital eye strain in children. This would remain unique to the pediatric population only [ 17 ]. At this point, there is sufficient evidence to suggest that this may be linked, but it would need further work to cement its place in the syndrome complex of digital eye strain.

Pathophysiology of DES

The symptoms experienced in computer vision syndrome are caused by three potential mechanisms: (i) Extraocular mechanism, (ii) accommodative mechanism, (iii) ocular surface mechanism [ 18 ].

Extraocular mechanisms not specifically linked with ocular usage may cause musculoskeletal symptoms such as neck stiffness, neck pain, headache, backache, and shoulder pain [ 16 ]. These symptoms are associated with postural problems secondary to improper placement of computer screens, unsuitable table or chair height, or incorrect distance between the eye and screen resulting in unnecessary stretching or forward bending often resulting in a muscular sprain [ 19 , 20 ].

Accommodative mechanisms cause blurred vision, double vision, presbyopia, myopia, and slowness of focus change [ 13 , 14 , 18 ]. Changes in accommodation lag have been noted secondary to digital device usage over prolonged periods [ 21 ]. However, the effects on accommodation, convergence, and pupillary size are mainly due to the demanding near work and not per se due to the screen [ 21 ]. The effect of blue light on visual health has also been studied in detail. However, at this point, there is a lack of consensus in the findings of these studies to address the health effects of blue-blocking spectacle lenses [ 22 ]. Table ​ Table1 1 summarizes results from research work done on blue-blocking glasses.

Published studies that explored role of blue-blocking filters on digital eye strain

An ocular surface mechanism causes symptoms such as dryness of the eyes, redness, gritty sensation, and burning after an extended period of computer usage. Eyeblink helps maintain a normal ocular surface through a whole cycle of secretion of tears, wetting of ocular surface, evaporation, and finally, drainage of tears [ 27 ]. It is now well known that the blink rate reduces significantly during computer usage from 18.4 to 3.6/min in one of the studies and from 22 to 7 blinks/min in another study [ 28 , 29 ].

The pathophysiology of reduced blink and squinting is bimodal; one, it increases the visual acuity in the presence of a refractive error and decreases the retinal illumination when using a source with glare in the superior visual field, as reported by Sheedy et al. [ 30 ]. Rather than the reduced blink rate, an incomplete blink, where the upper eyelid does not cover the entire corneal surface, may be more relevant to dry eye as the tear film stability can be maintained with a reduced blink rate, provided that most blinks are complete [ 31 ].

Apart from this, increased surface of cornea exposure caused by horizontal gaze at the computer screen and reduction of tear production due to the aging process and contact lens usage may also increase the digital eye strain.

Burden of DES and Associated Conditions

There has been massive growth in digital device usage in the past decade, hence increasing the risk of DES. There has been a surge of mobile devices in individuals across all age groups, with more elderly populations also reported to be engaged with digital media [ 3 ]. A report by the Vision Council in 2016 noted that in the USA, approximately two-thirds of adults aged 30–49 years spend five or more hours on digital devices [ 2 ]. The rampant use of social media is particularly pronounced among younger adults, with reportedly 87% of individuals between 20 and 29 years of age reporting the use of two or more digital devices simultaneously [ 2 ]. The burden of DES is challenging to measure because of the variability in symptoms reported across the literature. The computer-related symptoms could be due to accommodation anomalies (such as blurred near vision, blurred distance vision, and difficulty refocusing after prolonged computer work) and those that seemed linked to dry eye (dry eyes, eyestrain, headache, burning eyes, sensitivity to bright lights, and ocular discomfort). Before the COVID-19 pandemic, a highly variable prevalence of DES symptoms ranging from 5 to 65% have been reported [ 2 , 14 , 32 , 33 ]. Most of the studies reported dry eyes and accommodation anomalies as the presentation of DES, with refractive error, squinting, and blinking being studied less commonly. The data inconsistency was because these studies were either done through self-reported questionnaires, with variable definitions of DES being used and very little literature reporting the objectively determined DES [ 3 ]. Another shortcoming of the older (before COVID-19) studies is that the occurrence of DES amongst children was understudied [ 34 – 37 ]. In children, the prevalence of asthenopia due to presumed DES was about 20% before the pandemic [ 35 ]. The COVID-19 pandemic has increased our awareness of the DES and shed more light on the actual disease burden of DES, more so in the younger population. Table ​ Table2 2 summarizes the research work conducted prior to the COVID-19 pandemic.

Summary of research work published on digital eye strain prior to the COVID-19 pandemic

With the lockdown restrictions during the COVID-19 pandemic, outdoor activities were restricted for all age groups, and digital learning became the norm for almost 2 years. Hence, digital device usage increased throughout the world, exacerbating DES symptoms. DES prevalence amongst children alone rose to 50–60% in the COVID-19 era [ 44 – 46 ]. In children, the symptoms expanded to include recent onset esotropia and vergence abnormalities as part of the DES spectrum [ 47 , 48 ]. Overall, the incidence of DES was 78%, with participants reporting one or more DES-related symptoms [ 49 ]. This was primarily due to the overall time spent on digital devices (7–10 h/day) during the lockdown period, significantly greater than during the pre-curfew period (3–5 h) in all studies [ 49 , 50 ]. The virtual classes for children and “work from home policy” in office-going adults necessitated additional usage of digital devices. One of the most significant ocular health complications of the COVID-19 pandemic has been new-onset myopia and the increased progression of existing myopia due to excessive near work [ 17 , 50 , 51 ]. The prevalence of myopia has been nearly 50% in the COVID era, with accelerated progression from 0.3D in pre-COVID to 1D in the COVID era [ 52 ]. This influence on myopic progression has been maximum in the age group of 6–8 years [ 51 ]. Table ​ Table3 3 summarizes the findings from research work done during COVID-19 era. With time, we might have further studies detailing the increase in DES burden due to home confinement in COVID.

Review of literature of digital eye strain during the COVID-19 pandemic

Management Strategies

Digital screen-time refers to time spent in front of a screen, such as watching television, working on a computer, laptop, or tablet, using a smartphone, and playing video games. It is a sedentary lifestyle habit with excessive visual activity, which has implications both on ocular and general health hygiene [ 63 ]. Owing to home confinement during the COVID-19 pandemic, there has been a substantial rise in usage of the digital platform for work and education. As a result of the lack of outdoor activities and social interaction, people have resorted to television and social media for entertainment with an unintentionally increased dependence on these devices [ 64 , 65 ]. Wong et al. have rightly pointed out that the behavioral changes arising from this growing dependence may persist even after the COVID-19 pandemic [ 66 ].

The American Optometric Association has defined digital eye strain (DES) as an entity encompassing visual and ocular symptoms arising from the prolonged use of digital electronic devices [ 1 , 67 ]. It is characterized by symptoms such as dry eyes, itching, foreign body sensation, watering, blurring of vision, and headaches [ 3 ]. The prevalence of DES reported in the literature ranges from 25 to 93% [ 68 – 71 ] and a recent meta-analysis of available data linked to asthenopia associated with DES reported a pooled prevalence of 19.7% in the pediatric population [ 34 ].

Continuous staring at the screen leads to a decrease in the blink rate, causing dry eye-related problems. Smartphone use is more commonly associated with dry eye disease than other digital devices [ 72 ]. In a case–control study among school-going children, Moon et al. reported an association of 71% among smartphone users [ 39 ]. They also documented that symptoms of dry eye diseases were higher in the children above the age of 14 years than in the younger age group. This could be due to older children spending more hours on smartphones [ 73 ].

Visual work on a digital screen demands continuous focusing and refocusing in an attempt to see the pixelated characters clearly. Frequent eye movements to maintain focus lead to fatigue and eye strain. Shorter digital screen distance, a constant convergence, and accommodative demand further aggravate the asthenopic symptoms associated with DES [ 38 , 74 – 76 ].

Prolonged duration (> 4 h), improper posture, and inadequate lighting conditions are directly proportional to the DES symptoms [ 38 , 77 ]. Non-ocular symptoms associated with eye strain include stiff neck, general fatigue, headache, and backache [ 78 , 79 ].

Digital screen-time has also been considered as a potential modifiable environmental risk factor that can increase the risk of myopia progression. Prevention of myopia progression has been prioritized due to the associated risks of myopic macular degeneration, retinal detachment, glaucoma, and cataract [ 80 ].

Recommendations to alleviate DES include the ergonomic use of digital devices [ 74 , 81 , 82 ].

  • Average daily screen time should be reduced to a reasonable limit (≤ 4 h daily).
  • Digital device practices: proper ambient lighting, digital device positioning, adjusting image parameters (resolution, text size, contrast, luminance), and taking frequent breaks (20/20/20 strategy).
  • It is recommended to sit upright at a desk or table with screens approximately 20 inches from the eyes [ 6 ]. The height of the screen should be positioned lower than the height of the eyes, such that the viewing distance is 15–20° below the eye level. Frequent blinking of eyes minimizes the chances of developing dry eyes. The refence materials should be placed above the level of keyboard and below the level of monitor.
  • Environments with an illumination of over 1000 lx are known to decline user performance [ 83 ]. A contrast setting around 60–70% is considered comfortable by most people. The brightness should be adjusted such that the light coming from monitors matches the light in the surrounding workspace. Anti-glare screens can also help in reducing the amount of light reflected from the screens [ 1 ]. A clearly legible font of at least size 12 preferably in a dark color over light background should be chosen.
  • Screen time tracking allows to control excessive screen usage. It encourages to spend less time on digital devices.
  • Refractive error correction and use of glasses with antireflective coating [ 1 , 6 ].
  • Public education about the lasting effects of excessive screen time and encouraging healthier lifestyle practices.
  • Parents should be counseled to monitor their child's screen usage and incorporate family time.
  • Encourage children towards outdoor recreational activities.

There is strong evidence that increased screen time is associated with higher risks of an unhealthy diet, cognitive outcome, interpersonal relationships, and quality of life among children and young adults [ 84 ]. With the recent explosion of digital electronic device usage among children and young adults, there is an urgent need to educate the parents, caregivers, and youth about limiting digital screen time and implementing ergonomic practices of screen exposure.

Role of Ophthalmologists and Visual Health Specialists

There is a need to increase awareness about digital eye strain since digital screen devices have become an inseparable part of the lifestyle. Recently, the impact of digital eye strain (DES) has been felt across the population with the lockdowns and curfews imposed by the pandemic [ 53 , 62 ]. In the urban locales, there is some awareness about DES, but this is lacking in the rural and lower socio-economic groups, both of whom have seen an increasing screen exposure in recent years.

Eye-health strategies and awareness campaigns need to target the at-risk population. Awareness amongst digital device users can be channelized through doctors (physicians and ophthalmologists), health care workers (optometrists, vision technicians, and nursing staff), and non-medical professionals (wellness professionals, health and fitness experts, and information technology team leaders). A special emphasis should be made to raise awareness among teachers, since they are the ones who can offer early detection of DES symptoms at school, which is more important in the present times considering the increased dependency of education on digital devices.

Screen users need to be told to recognize symptoms of digital eye strain such as asthenopia, headache, neckache, red eyes, watery eyes, or burning sensation in the eyes. They need to be encouraged to make specific changes such as improving lighting, minimizing glare, taking regular breaks from the screen, changing focus to a distance object intermittently, following the 20-20-20 rule (taking a 20-s break every 20 min to look at an object 20 feet away) and using ergonomic chairs to reduce eye strain [ 85 ]. Frequent blinking needs to be emphasized too. Typically, we blink 14–16 times a minute, but this reduces to 4–6 times a minute when using screens [ 18 ]. Persistent symptoms despite these changes mark the need for an ophthalmic exam.

Parents and caregivers need to be sensitized to digital eye strain in children. There is a significant gap in the knowledge concerning DES and its potential harm, indicating a need to increase awareness in this group [ 50 ]. Parents and caregivers need to pick up on early signs that a child may be straining the eyes. Children often do not express ocular discomfort but may manifest certain mannerisms such as forced blinking or avoidance of screens or complain of transient episodic eye pain, rubbing, or epiphora, which may indicate eye strain [ 45 ]. Pediatricians and visual health specialists need to brief parents and teachers to recognize these signs and take remedial measures such as reducing screen time, using larger high-resolution displays, adjusting the lighting, and increasing outdoor activity. Over-the-counter lubricant drops can be considered in case of persistent symptoms, but an ophthalmology consult should be scheduled.

Innovation in screen technology has reduced the incidence of digital eye strain. These include high-resolution screens with inbuilt antireflective coating, matte-finished glass, edge-to-edge displays, and image smoothening graphic effects. Specific applications which remind screen users to take regular breaks also help inculcate screen-friendly habits. Innovations in the optical segment such as antireflective coating, blue-light blocking glasses, and polaroid lenses are other recommended measures to reduce eye strain.

Research and Knowledge Gaps

As it is pretty clear on the date that DES is not going to go away, it is essential from a public health perspective to focus on practical protective and preventive approaches concentrating on improving the vision-related quality of life of individuals affected with DES [ 86 ].

Despite the significant strides made concerning the understanding of DES, there are considerable gaps in research and knowledge pertinent to:

  • The symptomology of DES
  • Effective treatment strategies
  • Optimizing and customizing treatment options for different age groups based on the visual demands and symptoms
  • Preventative approaches to ameliorate the onset and severity of DES

The current assessment protocols for DES include aspects of understanding the visual symptoms in detail using a structured inventory, understanding task-specific visual demands, ergonomic concerns and considerations, comprehensive eye examination, refractive correction, binocular vision assessment, ocular surface assessment for dry eyes, and management based on the outcomes of the assessment [ 86 – 88 ].

Yet, in the symptomatology of DES, there is a considerable gap in understanding the association between the onset of visual symptoms and pre-existing visual dysfunctions. It has been shown that extensive use of digital devices can induce or exacerbate visual fatigue [ 3 , 82 , 83 ]. It is not clear if individuals who have a pre-existing binocular vision dysfunction, dry eyes, and related anomalies are at an increased risk for DES. Also, there is a considerable gap concerning the context of the type of digital device and the dynamic visual demands imposed by the same. Studies that aim at categorizing the visual symptoms based on the pre-existing visual dysfunction, visual needs, and visual profile can aid in a better understanding of the DES and can also provide insights into preventative approaches to mitigate the visual symptoms [ 12 ].

Management options for DES are symptoms-based and include a holistic and comprehensive approach, from the management of refractive errors, binocular vision anomalies, and ocular surface dryness to providing workplace recommendations to improve visual comfort. The global lifestyle disruptions due to COVID-19 resulted in a rapid rise in DES prevalence across all age groups [ 86 , 89 ]. The impact of DES on children was highlighted by various researchers that pointed out the need for visual protection measures to be followed during online learning. This included using appropriate screen settings, illumination and earning environment settings, posture requirements, adopting a healthy lifestyle, and regular eye examination [ 86 ].

Nonetheless, there are barely any studies exploring the optimal environmental conditions and efficacy of visual hygiene measures in ameliorating DES onset and prevalence [ 90 , 91 ]. Most of these guidelines are primarily expertise and consensus-based and need to be backed up by evidence. There is a clear need for further exploration to understand the cause-and-effect relationship between blue light and DES; when it comes to the effect of blue light illuminance and its association with visual fatigue, dry eyes, and retina damage [ 92 ], there is a clear need for further exploration to understand the cause-and-effect relationship between blue light and DES.

Similarly, there is a considerable lacuna in understanding mechanisms based on which anti-fatigue lenses work to reduce visual fatigue. Novel spectacle lens designs are being explored in this context. Hence, further explorations in this field should focus on recommendations for digital screens optimized to improve visual comfort [ 93 ] novel spectacle lens technologies to reduce visual fatigue associated with long hours of screen viewing, and inbuilt filters to optimize visual comfort [ 94 ]. A paradigm shift is required in our understanding of looking at DES as a man/instrument-made entity to explore customized solutions accordingly [ 91 ]. Overall, future research should focus on enhancing our understanding of DES from an etiological perspective, leading to evidence-based management options.

Conclusions

Digital eye strain has been on the rise since the beginning of the COVID-19 pandemic. An augmented growth pattern has been experienced with prevalence ranging from 5 to 65% in pre-COVID-19 studies to 80–94% in the COVID-19 era. The sudden steep increase in screen and chair time has led way to other silent pandemics like digital eye strain, myopia, musculoskeletal problems, obesity, diabetes etc. Digital device usage of more than 4 h/day, underlying refractive errors, female gender, and prior dry eyes are the most significant risk factors predisposing to DES. There is an urgent need for eye care professionals and vision health specialists to be well informed about DES. Awareness related to effects of excess screen time, ergonomic practices, and preventive measures needs to be spread especially among teachers, youngsters, and professionals exposed to excessive or prolonged screen time. The role of anti-glare screens, anti-fatigue lenses, and blue-blocking filters is still controversial and needs to be further explored. Future studies should focus on understanding the risk factors among different groups and the association between accommodative or binocular vision anomalies and DES.

Acknowledgements

No funding or sponsorship was received for this article.

All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article, take responsibility for the integrity of the work as a whole, and have given their approval for this version to be published.

Author Contributions

Concept and design: KK, BG; drafting manuscript: KK, BG, SN, SA, ND, JJ, JR, DS, SK, JS, DM; critical revision of manuscript: KK, BG, SK, ND, JJ; supervision: KK, BG, SA, SK, ND. All authors read and approved the final manuscript.

Disclosures

Bharat Gurnani, Kirandeep Kaur, Swatishree Nayak, Nilutparna Deori, Savleen Kaur, Jitendra Jethani, Digvijay Singh, Sumita Agarkar, Jameel Rizwana Hussaindeen, Jaspreet Sukhija, and Deepak Mishra have nothing to disclose.

Compliance with Ethics Guidelines

This review article is based on previously conducted studies. The article does not contain any studies with human participants or animals performed by any of the authors.

Contributor Information

Kirandeep Kaur, Email: moc.liamg@peednarikgnieb .

Bharat Gurnani, Email: moc.liamg@52tarahbinanrugrd .

Swatishree Nayak, Email: moc.oohay@eerhsitawsn .

Nilutparna Deori, Email: moc.liamg@iroedanraptulin .

Savleen Kaur, Email: moc.liamg@neelvasliam .

Jitendra Jethani, Email: moc.liamffider@inahtex .

Digvijay Singh, Email: moc.hgnisyajivgidrd@ofni .

Sumita Agarkar, Email: gro.liamns@rasrd .

Jameel Rizwana Hussaindeen, Email: [email protected] .

Jaspreet Sukhija, Email: moc.liamffider@ajihkusteerpsaj .

Deepak Mishra, Email: moc.oohay@21arhsimdrd .

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Coats’ disease: A case study of a 4-year old boy

Early and correct diagnosis of this congenital retinal vasculopathy vital to improve visual outcomes.

Right and left posterior pole of a 4-year-old patient with suspected Coats disea

Figure 1. Right and left posterior pole of a 4-year-old patient with suspected Coats disease. Note the subfoveal nodule with associated exudative retinopathy.

case study eye problems

This case study highlights the importance of a comprehensive eye examination with pupil dilation early in life, regardless of the presence or absence of signs and/or symptoms of pathology.

Recently, a 4-year-old African American male presented for his first eye examination. As per the child’s mother and father, the chief complaint was that he had failed a vision screening at his pediatrician’s office for the reasons of hyperopia and astigmatism in the right eye.

Observation the child walking back to the examination room showed a normal gait and overtly good attention to his surroundings. Medical history was unremarkable, and he was taking no medications. He also had no known medication or environmental allergies . Family history was remarkable for cataracts, high blood pressure, and glaucoma.

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Exam details

Entering uncorrected distance visual acuities by means of Allen pictures were 20/400 and 20/25 for the right eye and left eye, respectively. Near visual acuity was 20/20 with both eyes open. Color vision was normal for the left eye and was unable to be tested for the right eye. There was no frank stereopsis present.

The patient was not fully cooperative for cover test assessment, but Hirschberg testing showed no overt strabismus. Pupil testing, extraocular muscle function, and visual field assessment by means of quadrant screening were all unremarkable as well.

Anterior segment examination showed clear corneas, intact irides, open angles, and quiet lids, lashes, and conjunctivae. Anterior chambers were deep and quiet. Intraocular pressure measurements by means of rebound tonometry were 9 mm Hg in the right eye and 10 mm Hg in the left eye.

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Consent was obtained from the parents for dilation, and wet retinoscopy revealed +0.75 DS in the left eye and a highly variable reflex reading in the right eye ranging from +3.75 DS to +1.00 DS with a small but variable degree of with-the-rule astigmatism.

Posterior pole examination of both eyes is as shown in Figure 1. Note the raised nodular lesion underneath the fovea and the surrounding coalesced exudative retinopathy.

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I informed the child’s parents that my initial diagnosis was Coats’ disease and arranged for an urgent evaluation with a retina specialist.

I also explained the guarded visual prognosis for the right eye given foveal involvement and prescribed spectacles with impact-resistant lenses to be worn full-time to protect the left eye. At the time this piece was written, I had not heard the results of the child’s consultation with the retina specialist.

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Coats’ disease is a typically congenital retinal vasculopathy characterized by retinal telangiectasia and subsequent exudative retinopathy. 1 This condition is non-hereditary and is predominantly unilateral with a predilection for males. 2

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As Coats’ disease progresses, the potential for poor visual prognosis increases. 1 The most severe forms of this condition result in total retinal detachment, neovascular glaucoma, and phthisis bulbi, which are visually devastating and may necessitate enucleation. 3

Coats’ disease was first described in 1908 by George Coats as a unilateral vascular disease occurring in the retinas of young males. 4 It can have a highly variable clinical appearance based on the severity of the disease process at presentation.

Coats’ disease (along with, among other conditions, cataract, retinoblastoma, and persistent hyperplastic primary vitreous) is one of the causes of leukocoria and/or strabismus in a child. 4 This is one reason why patients with this condition may be referred for suspicion of retinoblastoma.

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As far as visual function is concerned, one finding which leads to a more negative prognosis is the presence of a subfoveal nodule. 1 Unfortunately, this patient has one of these nodules (see Figure 1). The nodules seen in some presentations of Coats’ disease contain fibrotic tissue and unfortunately have a predilection for the macula. 5 These subfoveal nodules can be associated with retinal–retinal anastomosis as evidenced by fluorescein angiography; 1 telangiectasias and associated areas of nonperfusion can also be evidenced in this way. 1

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Treatment of Coats’ disease is difficult and centers mainly around an attempt to lessen the retina’s demand for vascular growth. As such, laser photocoagulation and anti-vascular endotheliam growth factor (VEGF) therapy have shown efficacy in the earlier disease process, and anti-VEGF therapy with vitrectomy have shown efficacy in advanced disease. 6

As with any ocular disease, early and correct diagnosis coupled with timely treatment is key in the hopes of achieving a more favorable ocular and visual outcome. Therefore, Coats’ disease is one of the reasons ODs advocate for comprehensive eye examinations with pupil dilation early in life, regardless of the presence or absence of signs and/or symptoms of pathology.

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References:

1. Daruich AL, Moulin AP, Tran HV, Matet A, Munier FL. SUBFOVEAL NODULE IN COATS' DISEASE: Toward an Updated Classification Predicting Visual Prognosis. Retina. 2017 Aug;37(8):1591-1598. 2. Zhao Q, Peng XY, Yang WL, Li DJ, You QS, Jonas JB. Coats' disease and retrobulbar haemodynamics. Acta Ophthalmol. 2016 Jun;94(4):397-400. 3. Shields JA, Shields CL, Honavar SG, Demirci H, Cater J. Classification and management of Coats disease: the 2000 Proctor Lecture. Am J Ophthalmol. 2001 May;131(5):572-83. 4. Balmer A, Munier F. Differential diagnosis of leukocoria and strabismus, first presenting signs of retinoblastoma. Clin Ophthalmol. 2007 Dec;1(4):431-9. 5. Chang MM, McLean IW, Merritt JC. Coats' disease: a study of 62 histologically confirmed cases. J Pediatr Ophthalmol Strabismus. 1984 Sep-Oct;21(5):163-168. 6. Yang X, Wang C, Su G. Recent advances in the diagnosis and treatment of Coats’ disease. Int Ophthalmol. 2019 Apr;39(4):957-970.

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OTC Focus Case Studies: Eye Problems

The November OTC Case Studies feature patients with dry eye, hordeolum, and allergic conjunctivitis.

Case 1: Dry Eye Q: AJ is a 56-year-old woman who is complaining of a gritty sensation in her eyes, although they appear normal with white sclera. She is seeking advice about her dry eye and asks about omega-3 fatty acid supplements, which her neighbor said helped her. AJ is otherwise healthy and does not take any OTC or prescription medications. She started using a humidifier at home and repositioned her work station away from cooling and heating vents, but she did not find relief for her dry eye. She has also tried artificial tear eye drops (Hypotears/Tears Plus) and warm eye compresses, as recommended by her previous pharmacist. What information can you provide to AJ about omega-3 fatty acids for dry eye, and how do you recommend she treat her dry eye?

A: Omega-3 fatty acids have been recommended and commonly used to relieve dry eye symptoms, because of their anti-inflammatory properties; dry eye disease may be linked to a T-cell—mediated inflammatory process. Recently, a prospective, multicenter trial of omega-3 fatty acids versus a placebo did not show any relief in dry eye signs or symptoms over the 12-month study period. 1,2 Therefore, the American Academy of Ophthalmology did not include omega-3 fatty acids in its 2018 Preferred Practice Patterns for Dry Eye Disease. 1,2 AJ was correct to apply the environmental changes to avoid tear evaporation and preserve relative humidity. Given that she has not found relief with the low-viscosity ocular lubricant, the pharmacist should recommend that AJ use Genteal or Refresh eye drops, which contain more viscous lubricants: carboxymethylcellulose and hydroxypropylmethylcellulose. 3 The higher viscosity, the longer the gel-like drops will have ocular contact and the lower the tear dilution. If AJ does not find relief from the new eye drops, it may be appropriate for her to discuss topical glucocorticoids or punctal plugs with her eye care provider. 4

Case 2: Stye (Hordeolum) Q: LP is a 19-year-old female college student who has questions about a red painful bump on her right eyelid that appeared this morning. She does not have any underlying skin conditions, nor has she experienced this painful bump before, but she does recall that she left her makeup on overnight this weekend. LP’s roommate did some research on the eye abscess and concluded that it is an infection of the oil glands. LP does not take any medications other than her oral contraceptive, and she does not wear contact lenses. She is looking for an antibiotic eye drop. What are your recommendations on using antibiotics to treat a stye?

A: Let LP know that although a stye is an abscess of the eyelid, it only lasts a few days and can be managed without topical antibiotics or glucocorticoids. Some factors that may cause styes are contaminated or old eye cosmetics or contact lenses, keeping makeup on overnight, poor hygiene, and preexisting skin conditions, such as blepharitis and rosacea. One technique to facilitate drainage is to use warm compresses on the affected eyelid for about 5 to 10 minutes, 3 to 4 times per day. Additionally, try to massage and lightly wipe the affected eyelid after the compress. There is also an OTC ointment called Stye, a lubricant that contains mineral oil and white petrolatum to relieve some discomfort from the stye—but it does not treat the stye. The ointment should be applied after contact lens removal by pulling down the lower lid of the affected eye and applying one-fourth of an inch of ointment to the inside of the eyelid. LP should avoid trying to pop the stye or using cosmetics until the stye has cleared. If the stye does not reduce in size within 1 or 2 weeks, LP should be referred to an ophthalmologist. 5,6

Case 3: Foreign Substance Q: VZ is a 48-year-old woman who calls her local pharmacy about a foreign substance in her eye, which she thinks is a dust particle, because she had been cleaning out her attic. VZ wants advice on how to remove the particle and if she needs to seek emergency medical attention. What advice do you have, and can you recommend any OTC products for her to take home?

A: Advise VZ to purchase an irrigant. As long as she does not have an open wound in or near her eyes, she can attempt to remove the dust particle by ocular irrigation. This removes the debris while maintaining the moisture of the ocular tissue, because the osmolality and pH of the solution are balanced. All ocular irrigants are available over the counter and are typically large bottles labeled “eye wash” or “irrigating solution.” If VZ experiences changes in vision or ongoing redness or pain that does not settle, she should be referred to an eye care provider. If the foreign substance is metal or wood, VZ should seek attention from an eye care provider, because of the increased risk of corneal abrasion. 7,8

Case 4: Allergic Conjunctivitis Q: TP, a 27-year-old woman, wants advice about her recent symptoms of itchy, red, and watery eyes. Since the change in season, she has been more sensitive to the pollen count. Despite her efforts to keep windows closed, stay indoors, and use artificial tears, she has not found much relief. She does not wear contact lenses. What can you recommend to TP?

A: To relieve the redness and itching, TP should apply a cold compress to her eyes 3 or 4 times per day. She also should try ketotifen, an ophthalmic antihistamine/mast cell stabilizer. TP should use 1 drop in each eye 2 times per day. The onset of symptom relief from ketotifen is within minutes, and the duration of action is 12 hours. If TP does not experience relief after 72 hours of use, she should contact an eye care provider. 9,10

Ammie J. Patel, PharmD, BCACP, is a clinical assistant professor of pharmacy practice at the Ernest Mario School of Pharmacy at Rutgers University and an ambulatory care specialist at RWJBarnabas Health, part of the Barnabas Health Medical Group. Rupal Patel Mansukhani, PharmD, CTTS, FAPhA, is a clinical associate professor at the Ernest Mario School of Pharmacy at Rutgers University in Piscataway, New Jersey, and a transitions-of-care clinical pharmacist at Morristown Medical Center in New Jersey. Caitlyn Bloom, PharmD, BCACP, AE-C, is a clinical assistant professor at the Ernest Mario School of Pharmacy at Rutgers University and an ambulatory care clinical pharmacist at RWJBarnabas Health, part of the Barnabas Health Medical Group, in Eatontown, New Jersey.

  • Dry eye syndrome PPP - 2018. American Academy of Ophthalmology website. aao.org/preferred-practice-pattern/dry-eye-syndrome-ppp-2018. Published November 2018. Accessed September 5, 2019.
  • Lemp M. Advances in understanding and managing dry eye disease. Am J Ophthalmol. 2008;146(3):350-356. doi: 10.1016/j.ajo.2008.05.016.
  • Pucker AD, Ng SM, Nichols JJ. Over the counter (OTC) artificial tear drops for dry eye syndrome. Cochrane Database Syst Rev . 2016;2:CD009729. doi: 10.1002/14651858.CD009729.pub2.
  • Asbell PA, Maguire PG, Pistilli M, et al; Dry Eye Assessment and Management Study Research Group. n−3 Fatty acid supplementation for the treatment of dry eye disease. N Engl J Med . 2018;378(18):1681-1690. doi: 10.1056/NEJMoa1709691.
  • Lindsley K, Nichols JJ, Dickersin K. Non-surgical interventions for acute internal hordeolum. Cochrane Database Syst Rev . 2017;1:CD007742. doi: 10.1002/14651858.CD007742.pub4.
  • Neff AG Benign eyelid lesions. In: M Yanoff, JS Duker, eds. Ophthalmology. 3rd ed . Edinburgh, Scotland: Mosby; 2014:1295-1305.
  • Wipperman JL, Dorsch JN. Evaluation and management of corneal abrasions. Am Fam Physician . 2013;87(2):114-120.
  • Khare GD, Symons RC, Do DV. Common ophthalmic emergencies. Int J Clin Pract . 2008;62(11):1776-1784. doi: 10.1111/j.1742-1241.2008.01855.x.
  • Bielory L. Ocular allergy treatment. Immunol Allergy Clin North Am . 2008;28(1):189-224. doi: 10.1016/j.iac.2007.12.001.
  • O’Brien T. Allergic conjunctivitis: an update on diagnosis and management. Curr Opin Allergy Clin Immunol . 2013;13(5):543-549. doi: 10.1097/ACI.0b013e328364ec3a.

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  • Symptom Checker

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When to seek medical advice

Get emergency medical care if you have sudden changes in vision or an injury to your eye. Specific factors that may accompany urgent vision-related medical conditions include sudden onset of:

  • Severe eye pain or irritation
  • Vision loss or double vision
  • Eye floaters, flashes of light or halos around lights
  • Severe headache
  • Nausea or vomiting
  • Numbness or weakness on one side of the body
  • Confusion, dizziness or trouble talking

See a specialist in vision problems (optometrist or ophthalmologist) if you experience any vision problems that impair your ability to read or write comfortably, drive safely, or participate in everyday activities.

Eye problems in adults

Find possible causes of vision problems based on specific factors. Check one or more factors on this page that apply to your symptom.

  • Blurry distant objects
  • Blurry nearby objects
  • Blurry or blind spot in center of vision
  • Blurry vision at all distances
  • Bright zigzag lines
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  • Double vision
  • Fading of colors
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  • Progressive expansion of shadow or curtain over visual field
  • Seeing nonexistent things, or hallucinating
  • Sensitivity to light
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  • Usually no longer than 30 minutes
  • Confusion or trouble talking
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  • Swelling around the eye
  • Walls RM, et al., eds. Rosen's Emergency Medicine: Concepts and Clinical Practice. 9th ed. Philadelphia, Pa.: Elsevier; 2018. https://www.clinicalkey.com. Accessed Oct. 30, 2017.
  • Palmer J, et al. Abdominal pain mimics. Emergency Medicine Clinics of North America. 2016;34:409.
  • UpToDate. https://www.uptodate.com/contents/search. Accessed Oct. 30, 2017.
  • Zeiter D. Abdominal pain in children. Pediatric Clinics of North America. 2017;64:525.
  • Feldman M, et al. Sleisenger and Fordtran's Gastrointestinal and Liver Disease: Pathophysiology, Diagnosis, Management. 10th ed. Philadelphia, Pa.: Saunders Elsevier; 2016. https://www.clinicalkey.com. Accessed Oct. 30, 2017.
  • Merck Manual Professional Version. https://www.merckmanuals.com/professional. Accessed Oct. 30, 2017.
  • AskMayoExpert. Rochester, Minn.: Mayo Foundation for Medical Education and Research; 2017.
  • Kliegman RM, et al. Nelson Textbook of Pediatrics. 20th ed. Philadelphia, Pa.: Elsevier; 2016. https://www.clinicalkey.com. Accessed Nov. 2, 2017.
  • Zitelli BJ, et al., eds. Zitelli and Davis' Atlas of Pediatric Physical Diagnosis. Philadelphia, Pa.: Elsevier; 2017. https://www.clinicalkey.com. Accessed Nov. 11, 2017.
  • Ferri FF. Ferri's Clinical Advisor 2018. Philadelphia, Pa.: Elsevier; 2018. https://www.clinicalkey.com. Accessed Nov. 11, 2017.
  • Muncie HL, et al. Dizziness: Approach to evaluation and management. American Family Physician. 2017;95:154.
  • American College of Emergency Physicians. https://www.acep.org. Accessed Nov. 11, 2017.
  • U.S. Food and Drug Administration. http://www.fda.gov. Accessed Nov. 11, 2017.
  • Schmitt BD. Fever. In: Pediatric Telephone Protocols: Office Version 15th ed. Elk Grove Village, Ill.: American Academy of Pediatrics; 2015.
  • Mannenbach MS (expert opinion). Mayo Clinic, Rochester, Minn. June 14, 2017.
  • Goyal DG (expert opinion). Mayo Clinic, Rochester, Minn. June 14, 2017.
  • Hoecker JL (expert opinion). Mayo Clinic, Rochester, Minn. Aug. 28, 2017.
  • American Academy of Orthopaedic Surgeons. https://orthoinfo.aaos.org. Accessed Nov. 20, 2017.
  • Petty RE, et al., eds. Textbook of Pediatric Rheumatology. 7th ed. Philadelphia, Pa.: Elsevier; 2016. https://www.clinicalkey.com. Accessed Nov. 20, 2017.
  • Elsevier Point of Care. https://www.clinicalkey.com.  Accessed Nov. 20, 2017.
  • Kasper DL, et al., eds. Harrison's Principles of Internal Medicine. 19th ed. New York, N.Y.: McGraw-Hill Education; 2015. http://accessmedicine.mhmedical.com. Accessed Nov. 20, 2017.
  • Wein AJ, et al., eds. Campbell-Walsh Urology. 11th ed. Philadelphia, Pa.: Elsevier; 2016. https://www.clinicalkey.com.. Accessed Dec. 2, 2017.
  • National Eye Institute. https://nei.nih.gov. Accessed Dec. 5, 2017.
  • Wilkinson JM (expert opinion). Mayo Clinic, Rochester, Minn. Nov. 8, 2017.

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Case Study: Can You Name This Eye Problem?

An up-close look at a common eye lesion.

A 35-year-old woman presented to the emergency department reporting a three day history of right eye redness and pain. She endorsed constant irritation and redness, and she denied fever, itching, tearing, visual changes, or trauma to the eye. She reported that she had spent the prior week camping in the woods. On examination, the patient had a raised whitish-yellowish lesion on the nasal conjunctiva of her right eye, surrounded by mild erythema (Fig. 1 below). Her visual acuity was 20/20 bilaterally, and no foreign bodies or corneal abrasions were noted on fluorescein exam.

What are you looking at? 

case study eye problems

Diagnosis: Pingueculitis

A pinguecula is a common degenerative eye lesion, which typically appears as a yellowish to whitish elevated protrusion on the conjunctiva at the 9 or 3 o’clock position. Unlike pterygium, they do not cover the cornea. Prevalence increases with age.

Acute inflammation of a pinguecula results in pingueculitis. Treatment of pingueculitis includes (1) eye protection from sun, wind and dust (which are thought to contribute to pinguecula), (2) artificial tears, and (3) topical steroids, topical NSAIDs, or topical anti-histamines in cases of severe symptoms. Patients treated with steroids should be given prompt ophthalmology follow-up.

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The patient was discharged with artificial tears and topical steroids. She followed up in the ophthalmology clinic the next day and reported improvement in her symptoms.

  • Azhar SS. Acute Red Eye. Am Fam Physician . 2007 Sep 15; 76 (6):857-8. http://www.aafp.org/afp/2007/0915/p857.html
  • Mimura et al. Severity and Determinants of Pinguecula in a Hospital-Based Population. Eye Contact Lens . 2011 Jan; 37 (1):31-5. doi: 10.1097/ICL.0b013e3181f91f2f.
  • Gerstenblith A, Rabinowitz M, “Cornea” in The Wills Eye Manual: Office and Emergency Room Diagnosis and Treatment of Eye Disease. 6 th ed.

Dr. McVane is an Emergency Medicine Physician at Elmhurst Hospital in New York City

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Case-control studies

Susan lewallen md, paul courtright drph, bc centre for epidemiologic & international ophthalmology, university of british columbia, st paul’s hospital, vancouver v6z 1y6, canada, related content, introduction.

A case-control study is designed to help determine if an exposure is associated with an outcome (i.e., disease or condition of interest). In theory, the case- control study can be described simply. First, identify the cases (a group known to have the outcome) and the controls (a group known to be free of the outcome). Then, look back in time to learn which subjects in each group had the exposure(s), comparing the frequency of the exposure in the case group to the control group.

By definition, a case-control study is always retrospective because it starts with an outcome then traces back to investigate exposures. When the subjects are enrolled in their respective groups, the outcome of each subject is already known by the investigator. This, and not the fact that the investigator usually makes use of previously collected data, is what makes case-control studies ‘retrospective’.

Advantages of case-control studies

Case-control studies have specific advantages compared to other study designs. They are comparatively quick, inexpensive, and easy. They are particularly appropriate for (1) investigating outbreaks, and (2) studying rare diseases or outcomes.

An example of (1) would be a study of endophthalmitis following ocular surgery. When an outbreak is in progress, answers must be obtained quickly. An example of (2) would be a study of risk factors for uveal melanoma, or corneal ulcers. Since case-control studies start with people known to have the outcome (rather than starting with a population free of disease and waiting to see who develops it) it is possible to enroll a sufficient number of patients with a rare disease. The practical value of producing rapid results or investigating rare outcomes may outweigh the limitations of case-control studies. Because of their efficiency, they may also be ideal for preliminary investigation of a suspected risk factor for a common condition; conclusions may be used to justify a more costly and time-consuming longitudinal study later.

Consider a situation in which a large number of cases of post-operative endophthalmitis have occurred in a few weeks. The case group would consist of all those patients at the hospital who developed post-operative endophthalmitis during a pre-defined period.

The definition of a case needs to be very specific:

  • Within what period of time after operation will the development of endophthalmitis qualify as a case – one day, one week, or one month?
  • Will endophthalmitis have to be proven microbiologically, or will a clinical diagnosis be acceptable?
  • Clinical criteria must be identified in great detail. If microbiologic facilities are available, how will patients who have negative cultures be classified?
  • How will sterile inflammation be differentiated from endophthalmitis? Where are not necessarily any ‘right’ answers to these questions but they must be answered before the study begins. At the end of the study, the conclusions will be valid only for patients who have the same sort of ‘endophthalmitis’ as in the case definition.

Controls should be chosen who are similar in many ways to the cases. The factors (e.g., age, sex, time of hospitalisation) chosen to define how controls are to be similar to the cases are the ‘matching criteria’. The selected control group must be at similar risk of developing the outcome; it would not be appropriate to compare a group of controls who had traumatic corneal lacerations with cases who underwent elective intraocular surgery. In our example, controls could be defined as patients who underwent elective intraocular surgery during the same period of time.

Matching cases and controls

Although controls must be like the cases in many ways, it is possible to over-match. Over-matching can make it difficult to find enough controls. Also, once a matching variable has been selected, it is not possible to analyse it as a risk factor. Matching for type of intraocular surgery (e.g., secondary IOL implantation) would mean including the same percentage of controls as cases who had surgery to implant a secondary IOL; if this were done, it would not be possible to analyse secondary IOL implantation as a potential risk factor for endophthalmitis.

An important technique for adding power to a study is to enroll more than one control for every case. For statistical reasons, however, there is little gained by including more than two controls per case.

Collecting data

After clearly defining cases and controls, decide on data to be collected; the same data must be collected in the same way from both groups. Care must be taken to be objective in the search for past risk factors, especially since the outcome is already known, or the study may suffer from researcher bias. Although it may not always be possible, it is important to try to mask the outcome from the person who is collecting risk factor information or interviewing patients. Sometimes it will be necessary to interview patients about potential factors (such as history of smoking, diet, use of traditional eye medicines, etc.) in their past. It may be difficult for some people to recall all these details accurately. Furthermore, patients who have the outcome (cases) are likely to scrutinize the past, remembering details of negative exposures more clearly than controls. This is known as recall bias. Anything the researcher can do to minimize this type of bias will strengthen the study.

Analysis; odds ratios and confidence intervals

In the analysis stage, calculate the frequency of each of the measured variables in each of the two groups. As a measure of the strength of the association between an exposure and the outcome, case-control studies yield the odds ratio. An odds ratio is the ratio of the odds of an exposure in the case group to the odds of an exposure in the control group. It is important to calculate a confidence interval for each odds ratio. A confidence interval that includes 1.0 means that the association between the exposure and outcome could have been found by chance alone and that the association is not statistically significant. An odds ratio without a confidence interval is not very meaningful. These calculations are usually made with computer programmes (e.g., Epi-Info). Case-control studies cannot provide any information about the incidence or prevalence of a disease because no measurements are made in a population based sample.

Risk factors and sampling

Another use for case-control studies is investigating risk factors for a rare disease, such as uveal melanoma. In this example, cases might be recruited by using hospital records. Patients who present to hospital, however, may not be representative of the population who get melanoma. If, for example, women present less commonly at hospital, bias might occur in the selection of cases.

The selection of a proper control group may pose problems. A frequent source of controls is patients from the same hospital who do not have the outcome. However, hospitalised patients often do not represent the general population; they are likely to suffer health problems and they have access to the health care system. An alternative may be to enroll community controls, people from the same neighborhoods as the cases. Care must be taken with sampling to ensure that the controls represent a ‘normal’ risk profile. Sometimes researchers enroll multiple control groups. These could include a set of community controls and a set of hospital controls.

Table. Case-control studies: advantages and disadvantages

  • can obtain findings quickly
  • can often be undertaken with minimal funding
  • efficient for rare diseases
  • can study multiple exposures
  • generally requires few study subjects

Disadvantages

  • cannot generate incidence data
  • subject to bias
  • difficult if record keeping is either inadequate or unreliable
  • selection of controls can be difficult

Confounders

Matching controls to cases will mitigate the effects of confounders. A confounding variable is one which is associated with the exposure and is a cause of the outcome. If exposure to toxin ‘X’ is associated with melanoma, but exposure to toxin ‘X’ is also associated with exposure to sunlight (assuming that sunlight is a risk factor for melanoma), then sunlight is a potential confounder of the association between toxin ‘X’ and melanoma.

Case-control studies may prove an association but they do not demonstrate causation. Consider a case-control study intended to establish an association between the use of traditional eye medicines (TEM) and corneal ulcers. TEM might cause corneal ulcers But it is also possible that the presence of a corneal ulcer leads some people to use TEM. The temporal relationship between the supposed cause and effect cannot be determined by a case-control study.

Be aware that the term ‘case-control study’ is frequently misused. All studies which contain ‘cases’ and ‘controls’ are not case-control studies. One may start with a group of people with a known exposure and a comparison group (‘control group’) without the exposure and follow them through time to see what outcomes result, but this does not constitute a case-control study.

Case-control studies are sometimes less valued for being retrospective. However, they can be a very efficient way of identifying an association between an exposure and an outcome. Sometimes they are the only ethical way to investigate an association. If care is taken with definitions, selection of controls, and reducing the potential for bias, case-control studies can generate valuable information.

Recommended reading

1 Lischko AM, Seddon JM, Gragoudas ES, Egan KM, Glynn RJ. Evaluation of prior primary malignancy as a determinant of uveal melanoma. A case-control study. Ophthalmology 1989; 96(12): 1716-21

2 Seddon JM, Gragoudas ES, Glynn RJ, Egan KM, Albert DM, Blitzer PH. Host factors, UV radiation, and risk of uveal melanoma. A case-control study. Arch Ophthalmol 1990; 108(9): 1274-80

3 Leske CM, Warheit-Roberts L, Wu`Y. Open-angle glaucoma and ocular hypertension: the Long Island Glaucoma Case-control Study. Ophthalmic Epidemiology 1996; 3: 85-96.

4 Grisso JA. Making comparisons. Lancet 1993; 342: 157-60.

5 For information about Epi Info (Version 6), a word processing, database, and statistics program for epidemiology on microcomputers, please contact Centers for Disease Control and Prevention, Atlanta, GA 30333 [contact The Division of Surveillance & Epiemiology, Epidemiology Program Office]

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A case study of prevalence and causes of eye tracking data loss in a middle school classroom

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  • Published: 28 September 2022
  • Volume 70 , pages 2017–2032, ( 2022 )

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  • Xiaorui Xue 1 ,
  • Shiwei Xie 1 ,
  • Shitanshu Mishra 1 ,
  • Anna M. Wright 1 ,
  • Gautam Biswas 1 &
  • Daniel T. Levin 1  

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Recent advances in eye-tracking technology afford the possibility to collect rich data on attentional focus in a wide variety of settings outside the lab. However, apart from anecdotal reports, it is not clear how to maximize the validity of these data and prevent data loss from tracking failures. Particularly helpful in developing these techniques would be to describe the prevalence and causes of tracking failures in authentic environments. To meet this goal, we analyzed video records aligned with eye-tracking data collected from screen-mounted eye trackers employed in a middle-school classroom. Our sample includes records from 35 students recorded during multiple eye-tracking sessions. We compared student head position, body posture, attentiveness, and social interactions for time periods associated with successful and unsuccessful eye tracking. Overall, we observed substantial data loss and found that student inattentiveness, movements toward the eye tracker, and head rotations were the most prevalent factors inducing data loss. In addition, we observed a substantial relationship between data loss and apparent low involvement in the learning task. These data suggest that eye-tracking data loss is an important problem and that it can present a threat to validity because it can bias datasets to overrepresent high involvement behaviors. Based on these findings, we present several recommendations for increasing the proportion of usable data and to counter possible biases that data loss may introduce.

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Acknowledgements

The research in this report was supported by NSF grant 1623625 to DTL and GB.

This paper was supported by grant NSF Grant No. 1623625.

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Appendix A coding scheme

Social interaction (note: this section only describes participants’ the concrete verbal behaviors not whether they were on-task or off-task).

Verbal Talking: Is the student talking? 0 = no 1 = yes (note: if it is not specified, the coding for following other behaviors is aligned with this)

Non-verbal Sounds: This refers to the student makes noises. Is the student making non-verbal sounds?

Listening: Is the student listening to others?

Interacting with Teacher/Research Staff: Is the student talking or listening to Teacher/Research Staff?

Interacting with Classmate/Small Group of classmates: Is the student talking or listening to other students?

Task orientation and involvement

Off-task—Alone: Is the student, on his/her own, engaging in activities that do not relate to Betty's Brain? For example, the student is performing random movements that do not seem to have a goal, reading other materials, playing, etc.

Off-task—Social: Is the student engaging in activities with another student that do not relate to Betty's Brain? For example, the student is interacting with other students, doing things not associated with the Betty's Brain system.

Associated Activity—Alone: Is the student associative with others? Talking or listening to other students/teacher/research staff about Betty's Brain without asking or giving instruction. Is the student associative with others?

Associated Activity—Social: Talking or listening to other students/teacher/research staff about Betty's Brain without asking or giving instruction.

On-task—Alone. Is the student using the Betty's Brain system on his/her own?

On-task—Social. Is the student using the Betty's Brain system along with another student or with staff?

High: Mostly on-task both two seconds before and after the coding point.

Medium: On-task at least at the coding point but off task for some of the two seconds before and/or after the coding point.

Low: Mostly off-task both two seconds before and after the coding point.

Head position and camera occlusion

Off-screen Look: Is the student looking at anywhere else than the screen?

Forward Bending: Is the student forward bending? 0 = no 1 = yes, head 2 = yes, body 3 = yes, both head and body.

Backward Bending: Is the student backward bending? The student is leaning back toward the back of the chair.

Lateral Bending: Is the student lateral bending?

Rotation: Is the student's head rotating to the left or right?

Close to Screen: Is the student close to the screen? The full width of the student’s face takes approximately half or more of the width of the video window; the length of the student’s face takes approximately 2/3 or more of the height of the video window (The same computer was used to do the coding and reliability check).

Far from Screen: Is the student far from the screen? The student is leaning back, and the shoulder reaches the back of the chair.

Eyes-out-of-screen or Occluded: Are the student’s eyes out of the screen? 0 = no 1 = yes, one eye 2 = yes, both eyes

Not Present: Is the student not present in the video?

Eye Closed: Is the student closing eyes? 0 = no 1 = yes, half-closed/one eye closed 2 = yes, both eyes closed

Other general behaviors

Glasses: Is the student wearing glasses?

Touch Eye-tracker: Is the student touching the eye-tracker?

Move Computer: Is the student moving the eye-tracker?

Typing: Is the student typing?

Hat or hoodies: Is the student wearing a hat or hoodies?

Hands on Face: Are student’s hands on the face? 0 = no 1 = yes, on face 2 = yes, covering some of the eyes 3 = yes, covering the eyes

Stand: Is the student standing?

Multiple faces: Are there multiple faces in the video?

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Xue, X., Xie, S., Mishra, S. et al. A case study of prevalence and causes of eye tracking data loss in a middle school classroom. Education Tech Research Dev 70 , 2017–2032 (2022). https://doi.org/10.1007/s11423-022-10154-4

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DOI : https://doi.org/10.1007/s11423-022-10154-4

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  • Largest Covid Vaccine Study Yet Finds Links to Health Conditions

(Bloomberg) -- Vaccines that protect against severe illness, death and lingering long Covid symptoms from a coronavirus infection were linked to small increases in neurological, blood, and heart-related conditions in the largest global vaccine safety study to date.

The rare events — identified early in the pandemic — included a higher risk of heart-related inflammation from mRNA shots made by Pfizer Inc., BioNTech SE, and Moderna Inc., and an increased risk of a type of blood clot in the brain after immunization with viral-vector vaccines such as the one developed by the University of Oxford and made by AstraZeneca Plc. 

The viral-vector jabs were also tied to an increased risk of Guillain-Barre syndrome , a neurological disorder in which the immune system mistakenly attacks the peripheral nervous system.

More than 13.5 billion doses of Covid vaccines have been administered globally over the past three years, saving over 1 million lives in Europe alone. Still, a small proportion of people immunized were injured by the shots, stoking debate about their benefits versus harms.

The new research, by the Global Vaccine Data Network, was published in the journal Vaccine last week, with the data made available via interactive dashboards to show methodology and specific findings. 

Read More: Covid Test Failures Highlight Evolving Relationship With Virus

The research looked for 13 medical conditions that the group considered “adverse events of special interest” among 99 million vaccinated individuals in eight countries, aiming to identify higher-than-expected cases after a Covid shot. The use of aggregated data increased the possibility of identifying rare safety signals that might have been missed when looking only at smaller populations.

Myocarditis , or inflammation of the heart muscle, was consistently identified following a first, second and third dose of mRNA vaccines, the study found. The highest increase in the observed-to-expected ratio was seen after a second jab with the Moderna shot. A first and fourth dose of the same vaccine was also tied to an increase in pericarditis, or inflammation of the thin sac covering the heart. 

Safety Signals

Researchers found a statistically significant increase in cases of Guillain-Barre syndrome within 42 days of an initial Oxford-developed ChAdOx1 or “Vaxzevria” shot that wasn’t observed with mRNA vaccines. Based on the background incidence of the condition, 66 cases were expected — but 190 events were observed. 

ChAdOx1 was linked to a threefold increase in cerebral venous sinus thrombosis, a type of blood clot in the brain, identified in 69 events, compared with an expected 21. The small risk led to the vaccine’s withdrawal or restriction in Denmark and multiple other countries. Myocarditis was also linked to a third dose of ChAdOx1 in some, but not all, populations studied.

Possible safety signals for transverse myelitis — spinal cord inflammation — after viral-vector vaccines were identified in the study. So was acute disseminated encephalomyelitis — inflammation and swelling in the brain and spinal cord — after both viral-vector and mRNA vaccines. 

Listen to the  Big Take  podcast on  iHeart ,  Apple Podcasts ,  Spotify  and the Bloomberg Terminal.  Read the transcript .

Seven cases of acute disseminated encephalomyelitis after vaccination with the Pfizer-BioNTech vaccine were observed, versus an expectation of two.  

The adverse events of special interest were selected based on pre-established associations with immunization, what was already known about immune-related conditions and pre-clinical research. The study didn’t monitor for postural orthostatic tachycardia syndrome , or POTS, that some research has linked with Covid vaccines.

Exercise intolerance, excessive fatigue, numbness and “brain fog” were among common symptoms identified in more than 240 adults experiencing chronic post-vaccination syndrome in a separate study conducted by the Yale School of Medicine. The cause of the syndrome isn’t yet known, and it has no diagnostic tests or proven remedies.

Read More: Strenuous Exercise May Harm Long Covid Sufferers, Study Shows

The Yale research aims to understand the condition to relieve the suffering of those affected and improve the safety of vaccines, said Harlan Krumholz, a principal investigator of the study, and director of the Yale New Haven Hospital Center for Outcomes Research and Evaluation. 

Read this next :  Why Driving a Few Miles Can Save Patients a Fortune on Health Care

“Both things can be true,” Krumholz said in an interview. “They can save millions of lives, and there can be a small number of people who’ve been adversely affected.” 

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Ophthalmic Case Study 8

Case study 8 - cc: crossed eyes.

Patient History HPI: A 6 month-old female infant presents with occasional crossing of her eyes. Her parents believe that her left eye deviates nasally more than the right. The infant responds to light, tracks faces, and plays with toys without issue.

Past Ocular History: None

Ocular Medications: None

Past Medical History: Born at term without complications.

Surgical History: None

Past Family Ocular History: Mother with refractive error and maternal uncle with “lazy eye”. Paternal history unremarkable.

Social History: Lives at home with mom and dad. No smokers in home.

Medications: None

Allergies: None

ROS: Otherwise negative

Ocular Exam

Visual Acuity (cc): OD: Fixes and follows OS: Fixes and follows

IOP (tonoapplantation): OD: soft by palpation OS: soft by palpation

Pupils: Equal, round and reactive to light, no APD. No leukocoria.

Extraocular Movements: Full OU. No nystagmus.

Confrontational Visual Fields: Responds to light directed in four quadrants with each eye

External: Her left eye is crossed inward (esotropic). Her face is symmetric.

Other: Corneal reflection test (Hirschberg test): Reflection of a penlight directed at the infant is located in the center of the R pupil and at the temporal margin of the left pupil.

Cover-uncover test: On covering the R eye, the left eye shifts outward and fixes intermittently to a toy straight ahead. When the right eye is uncovered, the left eye shifts back inward. When covering the L eye the right eye remains straight looking at the target.

Alternate-cover test: When the cover is alternated from one eye to the other, there is an outward shift of the opposite eye on uncovering. Deviation measured at approximately 25 prism diopters base out.

Stereopsis: Unable to determine given patient age.

Retinoscopy: mild hyperopia OU (+1.00) without astigmatism

Diagnosis Infantile esotropia and amblyopia of the left eye

Differential Diagnosis: This patient is presenting with infantile esotropia. Other diagnoses to consider are pseudostrabismus (where prominent epicanthal folds give the appearance of crossed eyes) and accommodative esotropia (the convergence movement of the eyes is stronger than needed for accommodation. Palsies of the nerves that innervate the extraocular muscles (ex. cranial nerve 6) could result in esotropia. In adults, entrapment of extraocular muscles due to trauma or enlargement of the extraocular muscles due to graves orbitopathy can lead to strabismus. Systemic conditions, such as brain tumor or meningitis can cause sudden eye deviations. In this patient the eye exam revealed no extraocular muscle restriction or deficit and no refractive error. Her overall health was also normal.

Definition: Strabismus refers to the misalignment of the eyes and can present in a variety of ways. The most common forms are esotropia (inward deviation) and exotropia (outward deviation). Strabismus can also present as hypertropia (upward deviation) or hypotropia (downward deviation). Nasally directed misalignment of the eyes, or esotropia, that presents at < 6 months of age without other ocular findings is classified as infantile esotropia. The cause of infantile esotropia is unknown, but it is associated with maldevelopment of stereopsis, motion processing, and eye movements. Although vision can be normal in both eyes, up to 40% of these patients will have amblyopia. Amblyopia is defined as poor vision, either unilaterally or bilaterally, in an eye that is otherwise normal on clinical exam. Amblyopia is caused by reduced transmission of visual stimulus from the eye through the optic nerve to the brain for a prolonged duration during infancy and early childhood. For the visual system to develop properly, infants need to have adequate and symmetric exposure to visual stimuli. In the case of our patient, she has strabismic amblyopia of the left eye due to ocular misalignment

Examination: There are many potential causes of amblyopia, including anisometropia (unequal refractive error between eyes), strabismus (misaligned eyes), visual deprivation (secondary to cataract, ptosis, etc.), and organic (optic nerve hypoplasia, retinoblastoma). A complete ophthalmic exam including retinoscopy to determine refractive error and rule out cataracts, cover/uncover testing to unmask strabismus, and a dilated fundus exam to rule out optic nerve or retinal pathology should be done as part of the work-up for amblyopia.

Treatment: If recognized early and treated aggressively, amblyopia can be reversible to an extent. Treatment is most effective at early ages but results can be seen until age 9 or 10 when the visual system is still maturing. Treatment consists of patching or atropine penalization of the non-amblyopic eye, so that the amblyopic eye is forces to attend to visual stimuli and allow for developmental recovery. If the amblyopia is due to strabismus, surgery will likely be indicated.

  • anisometropia (difference in refraction between the two eyes)
  • congenital ptosis
  • optic nerve hypoplasia
  • pseudostrabismus
  • Patching the stronger eye
  • Doing strabismus surgery to align the eyes.
  • Waiting until the patient is in their teenage years to see if the weaker eye will become stronger with time
  • Placing dilating eye drops in the stronger eye to blur this eye
  • Using glasses to correct any refractive error
  • Pseudotropia
  • Hypotropia 

References/Resources:

Basic and Clinical Sciences Course Section 6: Pediatric Ophthalmology and Strabismus. Section chair: Gregg T Lueder, MD

Which is not a cause of amblyopia? d. Pseudostrabismus All the other diagnoses can result in amblyopia for the affected eye.

What is NOT an appropriate treatment for amblyopia? c. Waiting until the patient is in their teenage years to see if the weaker eye will become stronger with time Treatment of amblyopia should be started as soon as diagnosed and as young as possible.

What is the correct term to describe eyes that are misaligned so one eye is inward? b. Esotropia

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February 23, 2024

Flimsy Antiabortion Studies Cited in Case to Ban Mifepristone Are Retracted

Outside experts found that two studies cited in a federal case on medication abortion had serious design problems and that their authors had undisclosed conflicts of interest

By Liz Szabo

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A medical journal has retracted two studies examining the safety of the abortion pill mifepristone after a federal judge in Texas cited them when ruling that the drug should be taken off the market.

The studies, both retracted because of methodology problems and conflicts of interest, claimed abortions involving mifepristone are associated with an increased risk of serious complications compared with procedural abortions. Those conclusions are in contrast with hundreds of studies in the past two decades that have found that mifepristone—currently approved by the U.S. Food and Drug Administration for use in abortion through 10 weeks of pregnancy—is safe and effective. Mifepristone is used in combination with the drug misoprostol in nearly all medication abortions in the U.S., and medication abortions constituted more than half of abortions nationwide in 2020.

A third study that was written by the same authors but not referenced by the judge was also retracted; it was about doctors who prescribe mifepristone. All three papers were published in Health Services Research and Managerial Epidemiology, which is published by Sage Journals. They appeared in the journal in 2019, 2021 and 2022.

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The papers drew attention after the Alliance for Hippocratic Medicine, a group of antiabortion doctors and organizations, sued the U.S. Food and Drug Administration in November 2022. The alliance claimed that the FDA did not follow proper procedures in approving the drug more than two decades ago and that it has downplayed mifepristone’s risks . When filing its suit, the alliance also asked for a preliminary injunction to immediately remove mifepristone from the market.

In court documents, the U.S. Department of Justice (which represents the FDA in legal matters) described that request as “extraordinary and unprecedented.” The DOJ argued that “plaintiffs have pointed to no case, and the government has been unable to locate any example, where a court has second-guessed FDA’s safety and efficacy determination and ordered a widely available FDA-approved drug to be removed from the market—much less an example that includes a two-decade delay.”

Last April Judge Matthew Kacsmaryk of the Northern District of Texas cited the 2021 paper when he ruled that the alliance had standing to sue, agreeing with the plaintiffs’ claim that mifepristone puts a heavy burden on emergency room physicians treating pregnant people who experience medical complications. Kacsmaryk issued a preliminary ruling invalidating the FDA’s approval of mifepristone.

The Supreme Court halted the ruling until the U.S. Court of Appeals for the Fifth Circuit could issue a ruling. That court struck down part of Kacsmaryk’s ruling a few days later, allowing mifepristone to remain on the market with certain restrictions.

The appeals court ruling is on hold while the case is under consideration by the Supreme Court, which is scheduled to hear arguments about it in March.

For now, mifepristone remains available through 10 weeks of pregnancy, with prescriptions permitted by telemedicine and through the mail in states where abortion is legal.

Mifepristone’s Safety

Research shows that mifepristone, which has been used by more than five million pregnant people in the U.S. since it was approved in 2000 , has an excellent safety record, says Ushma Upadhyay, a professor and public health scientist at the University of California, San Francisco. “Judge Kacsmaryk’s decision ignored the science and relied on just the few cherry-picked research papers that supported his beliefs about abortion,” says Upadhyay, author of a new study, published last week in Nature Medicine , that found mifepristone can be safely prescribed through telemedicine.

A coalition of medical groups—including the American College of Obstetricians and Gynecologists and the American Medical Association —describe the evidence for mifepristone’s safety as “overwhelming.”

Serious side effects occur in fewer than 1 percent of those using the drug, according to a brief that the medical groups filed with the U.S. District Court for the Northern District of Texas before Kacsmaryk’s decision. Major adverse events such as significant infection, blood loss or hospitalization occur in fewer than 0.3 percent.

Deaths are even rarer. According to the FDA, of the estimated 3.7 million women who used mifepristone to terminate a pregnancy in the U.S. from 2000 to 2018, 24 died. This number includes those who had recently taken mifepristone and died from a cause that was not attributed to it, such as homicide, suicide or an overdose of another drug. That equates to a mortality rate of 0.00065 percent.

“The risk of death is almost non-existent,” the brief states. “Mifepristone is one of the most studied medications prescribed in the United States and has a safety profile comparable to [that of] ibuprofen.”

A study published in the journal Contraception last year found that the risk of death from pregnancy and childbirth is at least 35 times greater than from a legal abortion.

Controversial Studies

In a statement on its website, Sage Journals said it asked two independent experts to review the articles about mifepristone after a reader expressed concerns about the papers’ methodology and the authors’ undisclosed conflicts of interest.

In the 2021 study, which examined patient data from 1999 to 2015, the researchers found that abortion-related emergency department visits were 50 percent more likely after an abortion using mifepristone than a procedural abortion. This led them to conclude that “mifepristone abortion is consistently and progressively associated with increased morbidity” compared with procedural abortions.

But the study, which focused on people covered by Medicaid, provides little evidence that those individuals experienced an adverse event related to abortion, says Chris Adkins, an associate professor of pharmaceutical sciences at South University in Savannah, Ga., who has identified himself as the reader who questioned Sage Journals about the articles.

Pregnant people in the retracted 2021 study could have gone to the emergency department for any number of reasons, from food poisoning to earaches, Adkins says, adding that he doesn’t speak for his university. Research shows that half of emergency room visits made after an abortion are unrelated to abortion . And many people, often including those who qualify for Medicaid, go to the emergency room with nonemergency needs because they can’t access care anywhere else.

Some people who have medication abortions visit emergency departments “simply to determine if the amount of bleeding and cramping is normal,” Adkins says. “A significant number of these ER visits are just observational care and not a true abortion-related adverse event.”

The 2021 study also failed to provide important context, including the substantial increase in Medicaid enrollment during the study period (between 1999 and 2015), partly as a result of the Affordable Care Act, Adkins says. The number of Americans enrolled in Medicaid grew from 34.1 million in 2000 to 71.5 million in 2015.

Although the authors of the 2021 article declared that they had no conflicts of interest when they submitted it for publication, all but one were affiliated with antiabortion advocacy groups, including the Charlotte Lozier Institute, the Elliot Institute and American Association of Pro-Life Obstetricians and Gynecologists. That paper and a retracted study from 2022 by the same authors were funded by the Charlotte Lozier Institute, the research and education institute of Susan B. Anthony Pro-Life America, an influential antiabortion group.

A peer reviewer who originally evaluated the articles was also affiliated with the Charlotte Lozier Institute at the time, leading the publisher to later conclude that the reviewer’s work was “unreliable,” according to Sage Journals’ statement.

The independent experts who recommended the three retractions found that the articles from 2021 and 2022 contained “fundamental problems with the study design and methodology, unjustified or incorrect factual assumptions, material errors in the authors’ analysis of the data, and misleading presentations of the data that, in their opinions, demonstrate a lack of scientific rigor and invalidate the authors’ conclusions in whole or in part,” according to the statement.

James Studnicki, lead author of all three studies and vice president and director of data analytics at the Charlotte Lozier Institute, posted a point-by-point rebuttal of Sage Journals’ critique. He and his co-authors had made no attempt to hide their affiliations, he wrote. The articles did include a brief biography that noted researchers’ affiliations. In an e-mailed response to Scientific American, a Sage Journals spokesperson said it “relies on journal editors to make individual decisions on submitted works. These journal editors rely on peer reviewers to evaluate the quality of a submitted article and determine if it is rigorous and ultimately, if it is acceptable for publication. We work together to take corrective action when necessary.”

Studnicki and Tessa Longbons, a senior research associate at Charlotte Lozier Institute and a co-author of the three papers, claim their studies are being targeted because of politics. In a video posted online , Studnicki alleged that most medical journals are “virulently proabortion.”

“This incident points to a larger, newer phenomenon, which is that many of our scientific institutions and publications no longer stand in defense of open inquiry,” Studnicki and Longbons wrote in an e-mailed comment to Scientific American . “We’re seeing a biased elite faction across the medical community with all the power attempting to suppress any research that cuts against their approved, pro-abortion narrative. Scientific research and publication should be grounded in science, not driven by ideology.”

Critics of the retracted papers say their concerns are practical—not personal or political.

“This is not about ideology,” Upadhyay says. “The retraction of these studies is based on their flawed scientific approach which grossly distorts the safety rating for abortion.”

Effect on Future Legal Decisions

The retractions are “unlikely to make much difference legally” in terms of future court decisions or legislation, says Mary Ziegler, a professor at the University of California, Davis, School of Law, who studies the history of abortion.

State lawmakers trying to restrict or outlaw abortion generally seem more motivated by a desire to protect the fetus than by concerns about protecting pregnant people from potential adverse events, Ziegler says.

The Fifth Circuit Court of Appeals’ decision on mifepristone relied not on the retracted papers but on other testimony, she says.

The Supreme Court, which voted in 2022 to overturn Roe v. Wade (the landmark case that legalized abortion in 1973), is unlikely to be swayed by the retractions either, Ziegler says. “Given the problems with the plaintiffs’ case for standing, the Court may already be inclined to side against the Alliance for Hippocratic Medicine,” she says. “And if the justices are prepared to overlook other issues with standing and the weight of the evidence on mifepristone, the retractions will likely not do more than reinforce an existing position.”

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