NovaSight announced the publication of a clinical study, titled “High-adherence dichoptic treatment versus patching in anisometropic and small angle strabismus amblyopia: a randomized controlled trial” in the American Journal of Ophthalmology (AJO). The study showcases the effectiveness of NovaSight’s CureSight treatment, which leverages a binocular eye-tracking device to treat amblyopia, compared to traditional patching therapy.

The multicenter randomized controlled trial (RCT) demonstrated that patients who adhered to the CureSight treatment protocol achieved significantly greater improvements in visual acuity (VA) than those undergoing traditional occlusion therapy (patching). The trial involved 149 children with amblyopia, who were randomized into two groups: one receiving CureSight’s digitized binocular treatment, and the other undergoing traditional patching therapy.

Results from the per protocol (PP) dataset, which included 54 children treated with CureSight and 56 with patching, showed that CureSight led to superior outcomes. At the conclusion of the 16-week treatment period, the CureSight group achieved a mean improvement in distance VA of 2.8 lines, which was 0.53 lines higher than the patching group. Adherence rates were higher among CureSight users, with a median adherence rate of 94% compared to 83.9% in the patching group.

“This important breakthrough in amblyopia treatment is a reflection of NovaSight’s innovative technology, in addition to the patients’ willingness to adhere to the CureSight regimen, which is better than patching, to which adherence is generally less than optimal,” Dr. Tamara Wygnanski-Jaffe, the study’s lead author and Head of Pediatric Ophthalmology and Strabismus at Sheba Medical Center in Israel, said in company news release. Dr. Wygnanski-Jaffe is also the newly elected President of the International Pediatric Ophthalmology & Strabismus Council (IPOSC).

NovaSight also announced it has secured Chinese NMPA approval for CureSight, expanding the treatment’s availability to the world’s three largest healthcare markets: the US, Europe, and China. NovaSight plans to launch commercial operations in China by year’s end through a partnership with domestic distributor Fitlens, Zhuhai.