The Study
Single group, open label, efficacy, prospective trial recruiting amblyopic children aged 4-8 years with strabismus, anisometropia or both.
Eligible children had best-corrected amblyopic eye visual acuity (BCVA) of 0.4–1.18 logMAR, and 0.18 logMAR or better in the fellow eye. All the children were failure or reluctant to patching or atropine drops.
Each patient was instructed to daily watch TV shows & films, at home, using BinoVision™ for 30-60 min while using their best corrected visual acuity spectacles. The study was led by Dr. Chaim Stolovitch MD, Chief of Pediatric Ophthalmology & Strabismus Unit Tel Aviv medical center & Dana Children’s Hospital, Israel.
The Results
Mean VA in the amblyopic eye before treatment was 0.648 (±0.190). At week 4 visit, mean VA improved significantly to 0.46 (0.183 ± 0.144 lines) in the amblyopic eye (P=0.0004).
At week 8 visit, mean VA improved to 0.394 (0.254 ± 0.1.69 lines) (P=0.000437) and at week 12 to 0.386 (0.26 ± 0.185 lines) (P=0.00098) from base line VA.
15 patients were re-examined 12 weeks after cessation of treatment, demonstrating change in mean VA of -0.12 line (P=0.575) suggesting the effect sustained. 12 patients were re-examined 24 weeks after cessation demonstrating a very minor regression. As a control group, 8 patients completed 4 weeks of Sham (native images to both eyes, no stimuli protocol) and demonstrated no improvement from baseline VA in amblyopic eye.