Abstract
Purpose :
Introduction: A pivotal RCT study was conducted to evaluate the safety and efficacy of a novel treatment for amblyopia using the CureSight, a binocular- eye-tracking- based device compared with the golden standard of amblyopia treatment-patching.
Methods :
103 participants children aged 4-9 with anisometropic, strabismic or mixed amblyopia watched an internet content of their choice on the CureSight screen five times a week for 90 minutes vs. 7 days a week of 120 minutes of patching over 16 weeks . An eye tracker with a sampling rate of 90 Hz was used to identify the gaze position of each eye. During the treatment, patients wore anaglyph glasses over their habitual correction spectacles. Binocular stimulation movies using any internet or educational content were presented with the images of both eyes superimposed and the foveal area of the non-amblyopic eye blurred to a visual acuity of two lines below the acuity of the non-amblyopic eye. Best-corrected visual acuity (BCVA) at near and distance, stereo acuity, contrast sensitivity and reading performance were assessed. Primary efficacy endpointof the study was the mean change in distance BCVA of the amblyopic eye from baseline after binocular CureSight treatment, compared to that of patching. The secondary efficacy endpoint was the change from baseline to week 16 in in both study groups: stereo acuity test score, binocular distance and near BCVA and the amblyopic eye near VA.
Results :
Interim analysis of the pivotal study was conducted after approximately 90% of the evaluable cohort subjects completed the 16-week follow-up visit. The primary outcome results were defined as “favorable” according to the statistical analysis plan (CP ≥ 90%) for the pre-planned analysis with 87 completed subjects.
Conclusions :
The full study results are expected during February 2022 and will be presented at the conference.
This abstract was presented at the 2022 ARVO Annual Meeting, held in Denver, CO, May 1-4, 2022, and virtually.