Randomized Controlled Trial of a Dichoptic Digital Therapeutic for Amblyopia
Article Name: Randomized Controlled Trial of a Dichoptic Digital Therapeutic for Amblyopia
Amblyopia, also known as lazy eye, is a condition characterized by disturbance of binocular vision that occurs when vision is decreased in one or both structurally normal eyes, typically from a developmental issue during early childhood. When poor or mismatched visual information is conveyed to the brain, the response is to suppress the affected eye(s) which prevents development of the visual cortex from being achieved. Normally, treatment options involve refractive correction by forcing the affected eye to be utilized but early initiation and patient compliance are imperative for successful treatment.
What are the takeaway points from this article?
Recently dichoptic therapy has been gaining interest and uses video content and video games to treat amblyopia patients. Previously, 2 large RCTs failed to demonstrate efficacy possibly due to low adherence. The authors designed a digital therapeutic (Luminopia One) that was aimed to be more engaging using real-time modification of patient-selected, cloud-based video content within a virtual-reality headset. They evaluated their intervention with a phase 3 RCT at 21 clinical sites in the United States in children aged 4-7 with amblyopia. Patients in the treatment group used the device for 1 hour per day, 6 days per week with full-time refractive correction for 12 weeks. The stronger eye was provided with a 15% reduced contrast stream and dichoptic masks were superimposed on the images such that use of both eyes was required to appreciate the video content fully. At 12 weeks, amblyopic eye visual acuity improved by 1.8 lines in the treatment group compared with the glasses-only control group which improved by 0.8 lines (P = 0.0011; 96.14% CI, 0.33-1.63 lines). These findings support the clinical value of the therapeutic and future studies should evaluate the therapy with other methods and in other patient populations.
Reference: Xiao S, Angjeli E, Wu HC, Gaier ED, Gomez S, Travers DA, Binenbaum G, Langer R, Hunter DG, Repka MX; Luminopia Pivotal Trial Group. Randomized Controlled Trial of a Dichoptic Digital Therapeutic for Amblyopia. Ophthalmology. 2021 Sep 14:S0161-6420(21)00682-5. doi: 10.1016/j.ophtha.2021.09.001. Epub ahead of print. PMID: 34534556.
Date Published: September 13, 2021
Summary by: Neil Kamra