Session: Free papers Session II - Diagnostics & Amblyopia

Real-world results of binocular amblyopia treatment by CureSight, a home-use eye-tracking-based device

Introduction: Unlike traditional interventions such as patching or penalization, the binocular treatment, commercially available in the US and Europe as of 2023, has not been extensively explored outside clinical trials. We report the real-world efficacy of binocular treatment for amblyopia using the FDA-cleared CureSight™ eye-tracking-based device for home use.

Methods: Amblyopic children engaged in 90-minute sessions of self-selected internet content five times a week, accumulating a minimum of 18 monthly treatment hours. Baseline and follow-up assessments of visual acuity (VA) and stereo acuity were conducted, with adherence objectively monitored digitally through the eye detection software.

Result: Of the 69 children who reached their first follow-up visit with a mean treatment duration of 61 days, stereo acuity showed a notable median improvement of 0.3 log arcseconds with a significant mean improvement of 1.0 logMAR line in amblyopic eye VA (p<0.05), and a median adherence rate of 88%, of the required 30 monthly treatment hours. The high adherence observed with this binocular treatment distinguishes it from patching and penalization, where real-world adherence typically drops to 50% of the prescribed dose. The stereo acuity improvement is similar to that of CureSight's randomized clinical trials. The slightly lower VA gain compared to that reported in the studies with a similar training period is possibly due to the inclusion of off-label patients as far as age, eye deviation, and depth of amblyopia.

Conclusion: To the best of our knowledge, this is the first study to report the real-world effectiveness of the binocular treatment for amblyopia, emphasizing its potential advantages.