Daphna Mezad-Koursh1, Amir Rosenblatt2, Hadas Newman2, Chaim Stolovitch2. 1. Department of Ophthalmology, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. Electronic address: dmezad@gmail.com. 2. Department of Ophthalmology, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Abstract
PURPOSE: To evaluate the efficacy of the BinoVision home system as measured by improvement of visual acuity in the patient's amblyopic eye. METHODS: An open-label prospective pilot-trial of the system was conducted with amblyopic children aged 4-8 years at the pediatric ophthalmology unit, Tel-Aviv Medical Center, January 2014 to October 2015. Participants were assigned to the study or sham group for treatment with BinoVision for 8 or 12 weeks. Patients were instructed to watch animated television shows and videos at home using the BinoVision device for 60 minutes, 6 days a week. The BinoVision program incorporates elements at different contrast and brightness levels for both eyes, weak eye tracking training by superimposed screen images, and weak eye flicker stimuli with alerting sound manipulations. Patients were examined at 4, 8, 12, 24, and 36 weeks. RESULTS: A total of 27 children were recruited (14 boys), with 19 in the treatment group. Median age was 5 years (range, 4-8 years). Mean visual acuity improved by 0.26 logMAR lines in the treatment group from baseline to 12 weeks. Visual acuity was improved compared to baseline during all study and follow-up appointments (P < 0.01), with stabilization of visual acuity after cessation of treatment. The sham group completed 4 weeks of sham protocol with no change in visual acuity (P = 0.285). The average compliance rate was 88% ± 16% (50% to 100%) in treatment group. CONCLUSIONS: This pilot trial of 12 weeks of amblyopia treatment with the BinoVision home system demonstrated significant improvement in patients' visual acuity.
RCT Entities:
PURPOSE: To evaluate the efficacy of the BinoVision home system as measured by improvement of visual acuity in the patient's amblyopic eye. METHODS: An open-label prospective pilot-trial of the system was conducted with amblyopic children aged 4-8 years at the pediatric ophthalmology unit, Tel-Aviv Medical Center, January 2014 to October 2015. Participants were assigned to the study or sham group for treatment with BinoVision for 8 or 12 weeks. Patients were instructed to watch animated television shows and videos at home using the BinoVision device for 60 minutes, 6 days a week. The BinoVision program incorporates elements at different contrast and brightness levels for both eyes, weak eye tracking training by superimposed screen images, and weak eye flicker stimuli with alerting sound manipulations. Patients were examined at 4, 8, 12, 24, and 36 weeks. RESULTS: A total of 27 children were recruited (14 boys), with 19 in the treatment group. Median age was 5 years (range, 4-8 years). Mean visual acuity improved by 0.26 logMAR lines in the treatment group from baseline to 12 weeks. Visual acuity was improved compared to baseline during all study and follow-up appointments (P < 0.01), with stabilization of visual acuity after cessation of treatment. The sham group completed 4 weeks of sham protocol with no change in visual acuity (P = 0.285). The average compliance rate was 88% ± 16% (50% to 100%) in treatment group. CONCLUSIONS: This pilot trial of 12 weeks of amblyopia treatment with the BinoVision home system demonstrated significant improvement in patients' visual acuity.