Amblyopia occurs when there is abnormal development of the visual system early in life. Normal development of the visual cortex requires interpretation of clearly focused images from both eyes. When a developing child’s two eyes do not transmit the same image to the brain, the brain will suppress the image from one eye to prevent diplopia or unclear perception. Causes include unequal refractive errors between the eyes (refractive amblyopia), obstructed vision (such as from a cataract) that is worse in one eye (obstructive amblyopia), or misalignment of the eyes (strabismic amblyopia). Over time, the brain relies more on the stronger eye while vision in the weaker eye gets worse. Amblyopia typically affects one eye but can also be a bilateral condition. It is the most common cause of vision loss in children. Early treatment therapy is over 90% effective and prevents long-term vision problems.
Treatment of amblyopia begins with correction of visual refraction, obstruction, or misalignment. This is combined with treatments that encourage use of the amblyopic eye. The most commonly used methods for this are to occlude the better-seeing eye, such as with periodic patching, or by blurring vision in the better-seeing eye, such as with atropine drops. Better results are seen when therapy is started as soon as possible after diagnosing amblyopia. Treatment is continued until visual acuity is normal or is no longer improving on multiple observations taken several months apart.
Products and/or software programs investigated for medical use include, but are not limited to, Luminopia One, CureSight and RevitalVision. Over-the-counter virtual reality (VR) systems may be used to utilize therapy software. Patients put on a VR headset or specialized glasses and are then shown “therapeutically modified” TV shows and movies. The patient and/or caregiver can choose from a variety of media content, and the system then uses algorithms to modify the selected content to help a child’s brain take in stimuli from both of their eyes.
The use of digital therapeutic systems for the treatment of amblyopia is considered EXPERIMENTAL/INVESTIGATIVE due to the lack of clinical evidence demonstrating an impact on improved health outcomes.
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Summary of Evidence
Available evidence on the use of digital therapeutics in the provision of amblyopia therapy is currently lacking. Although treatment adherence and caregiver satisfaction were high, there is no clear benefit or advantage in visual acuity over treatment with corrective glasses alone. In the future, randomized controlled trials (RCT) will need to examine the benefit of digital therapeutics over current standard of care treatments.
Rationale
The pivotal trial randomized 103 children aged 4 to 9 years to undergo treatment with the CureSight digital therapeutics product or eye patching. CureSight was found to be non-inferior to patching. At 16-week follow-up, best corrected visual acuity (BCVA) improvement was greater in the CureSight group compared with patching; significant improvements in stereoacuity occurred with both CureSight and patching. Mean adherence to CureSight treatment was 93%, and 93% of parents reported they were likely or very likely to choose CureSight over patching. Interim results of the pivotal trial were presented at the June 2022 meeting of the Association for Research in Vision and Ophthalmology (ARVO). Safety and efficacy of the therapy versus patching or atropine is unknown, as is the durability of benefit from use of the digital therapeutic .
A technology report on Luminopia One (Luminopia Inc.) for the treatment of amblyopia in children was published in an evolving evidence report in 2023. According to the report, a review of full-text clinical studies suggests minimal support for using Luminopia One for the treatment of amblyopia in children aged 4 to 7 years. Findings were based on the following factors: One fair-quality randomized controlled trial (RCT) and 1 very poor-quality noncomparative study were identified, Luminopia One was not compared with standard of care treatments (e.g., patching or atropine); the only comparative study examined the incremental benefit of adding Luminopia One to corrective glasses alone without a sham comparison, and although treatment adherence and caregiver satisfaction were high, there is no clear benefit or advantage in visual acuity over treatment with corrective glasses alone.
Reference List
1. U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). De Novo Classification Decision Summary for Luminopia One (Luminopia, Inc., Cambridge, MA). No. DEN 210005. 2021. Available at URL: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN210005.pdf .
2. U.S. Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). 510(k) Premarket Notification Summary for CureSightCS 100 System. (NovaSight, Ltd., Airport City, Israel) No. K221375. Silver Spring, MD. Available at URL: https://www.accessdata.fda.gov/cdrh_docs/pdf22/K221375.pdf
3. Xiao S, Angjeli E, Wu HC, et al. Randomized Controlled Trial of a Dichoptic Digital Therapeutic for Amblyopia [published correction appears in Ophthalmology. 2022 May;129(5):593]. Ophthalmology. 2022;129(1):77-85. doi:10.1016/j.ophtha.2021.09.001
4. Bjeloš M, Sonicki Z, Bušić M, Ćurić A, Elabjer BK. Re: Xiao et al.: Randomized controlled trial of a dichoptic digital therapeutic for amblyopia (Ophthalmology. 2022;129:77-85). Ophthalmology. 2022;129(10):e151-e152. doi:10.1016/j.ophtha.2022.06.015
5. NIH: U.S. National Library of Medicine. ClinicalTrials.gov.
6. Hayes Evolving Evidence Review, Luminopia One (Luminopia Inc.) for Treatment of Amblyopia in Children, April 14, 2023. Available at: https://evidence.hayesinc.com/report/eer.luminopia5416
7. Hayes Emerging Technology Report, CureSight for Amlyopia in Children, October 12, 2022. Available at: https://evidence.hayesinc.com/report/pg.curesight
8. Wallace DK, Repka MX, Lee KA, et al. Amblyopia Preferred Practice Pattern®. Ophthalmology. 2018;125(1):P105-P142. doi:10.1016/j.ophtha.2017.10.008
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