NovaSight publishes CureSight’s pivotal study of 1-year follow-up outcomes

(Image Credit: AdobeStock/Marinesea)

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

The study, published in theAmerican 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 one year. The pivotal randomly assigned 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 current gold-standard-of-care in amblyopia.

According to NovaSight, the pivotal study was carried out in 6 medical centers. This included Sheba Medical Center, ranked one of the top 10 best hospitals in the world by Newsweek, in 2024. This was the first large scale RCT in which a digital device was demonstrated to be non-inferior to the patching treatment for children with amblyopia.

In this prospective follow up study, 38 patients out of the 43 patients who were initially treated for 16 weeks with CureSight were reevaluated 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).¹

This study shows that improvements after 16 weeks of dichoptic binocular treatment were maintained 52 weeks post-treatment.¹

The authors pointed out that the follow-up study is not without limitations.

“For example, our treatment mandates the subject remain seated in front of a digital screen, rather than having the ability to move freely,” they wrote. “However, this is alleviated by the short weekly treatment time, which should not adversely impact other physical and outdoor activities. Additionally, the streamed digital content is fully customizable by parents, allowing parents to opt for educational content (i.e., homework) that would not add to the overall screen time for the child.”

The authors concluded that the CureSight system improves vision in children with amblyopia after a short treatment time and those improvements are maintained through at least 52 weeks post-treatment.

“Long-term results of binocular treatments for amblyopia are rarely reported in clinical trials, they wrote. “In this clinical trial with CureSight, improvements in amblyopic eye's acuity, binocular acuity and stereoacuity were maintained 1 year after treatment completion.”

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 (VA) and stereoacuity that is carried out while the child watches any streamed content of their choice on a user-friendly digitized tablet from the comfort of their home. Using complex 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.

“This study shows that improvements after 16 weeks of binocular treatment were maintained 52 weeks post-treatment, with amblyopia recurrence rates comparable to those reported in the literature,” Burton J. Kushner, MD, professor emeritus in the Department of Ophthalmology & Visual Sciences at the University of Wisconsin, and a member of the CureSight Pivotal Trial Group, said in the news release. “I believe CureSight and its capabilities will help providers like myself engender a positive feeling about amblyopia treatment in our young patients and their caregivers,” he added.

Following its FDA clearance in October 2022, NovaSight launched the CureSight Referral Program in the US in early 2023 and experienced great adoption by both eye care providers and patients. Over 250 eye care providers, including both Ophthalmologists and Optometrists from private clinics and renowned institutions such as Berkely University, Duke University, Cleveland Clinic, Thomas Eye Group and Seattle Children’s Hospital, have joined the program, which has already generated more than 650 patient referrals. Post market data shared by eye care providers of the CureSight Referral Program revealed significant visual acuity and stereoacuity improvement with high compliance and satisfaction rates in a real world setting.

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.

"We are excited to announce that a leading healthcare-focused venture capital firm has made a substantial investment, solidifying their firm commitment to spearhead NovaSight's Series B round funding. NovaSight welcomes further participation from interested investors, as we collectively endeavor to revolutionize the pediatric vision care sector," said Ran Yam, NovaSight CEO and Co-Founder.

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

Reference:

1. Tamara Wygnanski-Jaffe, Avital Moshkovitz, Burton J. K?ushner, Michael Belkin, Oren Yehezkei. Binocular Home Treatment for Amblyopia: Gains Stable for One Year. American Journal of Ophthalmology. Published February 13, 2024. Accessed March 13, 2024. SOI: https://doi.org/10.1016/j.ajo.2024.02.004