NovaSight has announced the publication of a company-funded study demonstrating long-term vision gains achieved with CureSight, the company’s digitized, at-home amblyopia (lazy eye) treatment.

The study, published in the American Journal of Ophthalmology, found that children with various types of amblyopia showed significant improvement in both visual acuity (VA) and stereoacuity following short-term binocular treatment with CureSight, and that the gains were maintained for at least 1 year.

The Randomized Controlled Trial (RCT), which enrolled 103 participants aged 4 to under 9 years, compared vision and stereoacuity improvement outcomes with CureSight versus eye patching. The study was carried out in six medical centers. This was the first large scale RCT in which a digital device was demonstrated to be noninferior to the patching treatment for children with amblyopia, according to NovaSight.

In this prospective follow up study, 38 patients out of the 43 patients who were initially treated for 16 weeks with CureSight were re-evaluated at 12 weeks post-treatment, and 27 patients were evaluated at 1-year post-treatment. At 12-weeks post-treatment, improvement in amblyopic eye VA was maintained with no statistically significant change compared to the end-of-treatment visit. At 1 year, there was a partial reduction in the amblyopic eye VA gain compared to end-of-treatment but with a statistically significant residual gain of two lines compared to baseline, (0.20±0.14 LogMar Mean, SD). Gains in stereoacuity and binocular VA were significantly maintained compared to baseline at both 12-weeks and 1-year post-treatment (P<0.0001), with no change from end-of-treatment (P>0.05).  

CureSight is an FDA-cleared and CE marked eye-tracking-based digital treatment program for amblyopia that is indicated for improvement of both visual acuity and stereoacuity that is carried out while the child watches any streamed content of their choice on a digitized tablet from home. Using algorithms and eye-tracking technology, CureSight constantly blurs the center of the image that is presented to the strong eye by real time image processing while the image presented to the lazy eye remains sharp. This encourages the brain to complete the image’s fine details from the amblyopic eye and improves acuity while enabling the visual system to process both eyes’ images simultaneously as the eyes learn to work together as a team.

Following its FDA clearance in October 2022, NovaSight launched the CureSight Referral Program in the US in early 2023. Over 250 eye care providers, including ophthalmologists and optometrists from private clinics and institutions have joined the program, which has generated more than 650 patient referrals. NovaSight is planning a full commercial rollout in the US in parallel to commercial launch of CureSight in Europe and China in 2024. To support its commercial and research and development activities, NovaSight has initiated a B round with a firm commitment in place by a healthcare-focused venture capital firm to lead the round through a significant investment.

NovaSight will be exhibiting at the 2024 Annual AAPOS (American Association for Pediatric Ophthalmology and Strabismus) meeting, April 7-11, and holding a dedicated symposium on April 10 to share the latest updates on CureSight, discuss long-term results of CureSight’s pivotal study, and share real-world case studies.