Yehezkel O, et al. A prospective, multicenter, randomized, masked, controlled pivotal trial to assess the safety and effectiveness of an eye-tracking-based treatment for amblyopia under binocular conditions vs. patching – interim results. Presented at: Association for Research in Vision and Ophthalmology meeting; May 1-4, 2022; Denver.
Disclosures: Yehezkel reports being employed by NovaSight.
DENVER — Children with amblyopia treated with an at-home device experienced improvement in visual acuity and binocularity, according to a study presented at the Association for Research in Vision and Ophthalmology meeting.
Oren Yehezkel, PhD, reported data from a pivotal randomized controlled trial that compared the CureSight (NovaSight) eye tracking-based device to patching in children with amblyopia.
“Other studies have shown that the compliance for patching is about 50%,” he told Healio/OSN. “Children tend not to like the patch. This [device] gives them a chance to watch whatever they want from the internet.”
CureSight separates content into two channels and blurs the central vision of the normal eye. Yehezkel said the device encourages children to use both eyes.
One hundred children with amblyopia were randomly assigned to treatment with either the CureSight device or patching for the 16-week study. The primary endpoint was noninferiority of amblyopic eye best corrected visual acuity improvement at 16 weeks. Binocular visual acuity and stereoacuity improvement, as well as adherence and satisfaction, were also recorded.
Yehezkel said the device met the primary endpoint of noninferiority, and improvement of distance visual acuity in the amblyopic eye was higher in the CureSight group than the patching group at week 16. Improvement of binocular visual acuity was also higher in the CureSight group.
Participants in the CureSight group had higher mean adherence at 16 weeks, and 93% of parents reported they are likely or very likely to choose CureSight over patching.
“The mean adherence was 95% vs. only 79% for the patch, so it was much higher,” Yehezkel said. “The children tend to like it because they can see anything they like.”