Abstract
Introduction: A study was conducted to evaluate the safety and effectiveness of a novel treatment for amblyopia using a binocular- eye-tracking- based device (CureSight). Methods: 20 children aged 4-16 (8.08 ±3.2 years) with anisometropic, strabismic or mixed amblyopia watched a movie of their choice five times a week for 90 minutes over three months, followed by three weekly sessions for additional three months. An eye tracker with a sampling rate of 90 Hz was used to identify the gaze position of each eye. Dichoptic movies were presented with the foveal area of the non-amblyopic eye blurred to visual acuity two lines below the acuity of the amblyopic eye. Best-corrected visual acuity (BCVA) at near and distance, stereo acuity, and reading performance were assessed. Six months of follow-up. Results: The mean compliance with treatment dosage was 95%. BCVA improved by 3.34 ±0.05 ETDRS lines for near (95% CI, 0.235-0.375; P<0.005) and by 1.8 ±0.04 for distance (95% CI, 0.145-0.257; P<0.005). Binocular VA improved by 1.1 ± 0.04 and 0.13 ± 0.03 lines for near and distance (P<0.01; paired t-test). The mean stereoacuity improved from 285 ± 66 to 73 ±14 arcsec (3-octave steps 95% CI, 105-292; P <0.005). Reading speed improved by an average of 40%. No adverse effects were reported. Two children reported difficulty adhering to the study protocol. Conclusion/relevance: Subjects significantly improved VA of the amblyopic eye, stereo acuity, and reading speed. Improvement of binocular VA indicates a reduction in intraocular suppression. The tested Curesight system is a potentially effective home treatment for amblyopia, with high compliance and no difficulty in fitting or calibration, with a year of follow-up.