NovaSight, a rapidly growing pediatric-focused eyecare company, is pleased to announce publication of “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 demonstrated that amblyopia patients who adhered to the CureSight treatment protocol — using the company’s novel binocular eye-tracking device — achieved greater improvements in visual acuity (VA) than those undergoing traditional occlusion therapy, or patching, in a multi-center randomized controlled trial (RCT).
The study included 149 children with amblyopia (also known as “lazy eye”) who were randomized to either CureSight digitized binocular treatment or patching.
Results from the per protocol (PP) dataset of the trial (n=54) demonstrated that CureSight was significantly more effective than patching with greater VA improvements and higher adherence rates compared to those undergoing patching (n=56).
The mean improvement in distance VA in the PP CureSight group at the conclusion of a 16-weeks treatment was 2.8 lines, which was 0.53 lines higher than what was achieved in the patching group. Median adherence in the modified intent-to-treat (mITT) CureSight group was 94%, which was also significantly higher than in the patching group, at 83.9%.1
“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,” said Tamara Wygnanski-Jaffe, MD. Tamara Wygnanski-Jaffe is the lead author of the study, head of the Pediatric Ophthalmology and Strabismus service at the Sheba Medical Center in Ramat Gan, Israel, and recently nominated as president of the International Pediatric Ophthalmology & Strabismus Council (IPOSC).
“This study showing CureSight’s superiority over patching marks a major milestone in amblyopia treatment advancements and builds on previous peer-reviewed studies demonstrating CureSight’s non-inferiority to patching and preservation of visual gains,” said Ran Yam, NovaSight CEO and co-founder.
In 2022, a study showing that binocular treatment with CureSight was non-inferior to patching in amblyopic children was published in Ophthalmology, the journal of the American Academy of Ophthalmology (AAO)2, and earlier this year, a study published in the American Journal of Ophthalmology showed that children with amblyopia who have experienced significant improvement in both VA and stereoacuity following binocular treatment with CureSight maintained these gains for at least one year.3
“The entire body of CureSight clinical trial evidence — and the most recent findings in particular — demonstrate that this treatment can greatly benefit our patients. As a clinical investigator in a CureSight clinical trial, I had the opportunity to offer this treatment to my patients and I found that it is easy to use, effective, and appealing to children,” said Nicholas Sala, DO, of Pediatric Ophthalmology of Erie, Inc., in Erie, Pennsylvania. Dr. Sala is an active member of the Pediatric Eye Disease Investigator Group (PEDIG), a consortium of pediatric ophthalmologists across the U.S. and Canada.
Regulatory Approval Update
The company also announced that in addition to the U.S. FDA clearance and the European CE Mark, CureSight has been recently granted the Chinese NMPA (formerly CFDA) approval, which expands CureSight’s availability to all three largest global markets. The NMPA approval was received following a successful multi-center study conducted in four leading medical centers in China. NovaSight intends to initiate CureSight-associated commercial activities in China — which will be managed by its local team in Beijing, Changsha, and Hainan — before the end of the year through a domestic distribution partnership with Fitlens, Zhuhai.
References:
Wygnanski-Jaffe T, Kushner BJ, Moshkovitz A, Belkin M, Yehezkel O; CureSight Pivotal Trial Group. High-adherence dichoptic treatment versus patching in anisometropic and small angle strabismus amblyopia: a randomized controlled trial. Am J Ophthalmol. 2024 Aug 21:S0002-9394(24)00374-X. doi: 10.1016/j.ajo.2024.08.011. Epub ahead of print. PMID: 39179129.
Wygnanski-Jaffe T, Kushner BJ, Moshkovitz A, Belkin M, Yehezkel O; CureSight Pivotal Trial Group. An Eye-Tracking-Based Dichoptic Home Treatment for Amblyopia: A Multicenter Randomized Clinical Trial. Ophthalmology. 2023 Mar;130(3):274-285. doi: 10.1016/j.ophtha.2022.10.020. Epub 2022 Oct 26. PMID: 36306974.
Wygnanski-Jaffe T, Moshkovitz A, Kushner BJ, Belkin M, Yehezkel O; CureSight Pivotal Trial Group. Binocular Home Treatment for Amblyopia: Gains Stable for One Year. Am J Ophthalmol. 2024 Jun;262:199-205. doi: 10.1016/j.ajo.2024.02.004. Epub 2024 Feb 14. PMID: 38360334.