NovaSight Announces Pivotal Trial for Digital Lazy Eye Treatment
NovaSight announced today that it is running a large pivotal trial for its CureSight digital lazy eye treatment device.
The pivotal trial of Airport City, Israel-based NovaSight has seen the company gain FDA 510 (k) approval for the CureSight device, according to a press release.
CureSight is a lazy eye tracking-based eye treatment that NovaSight officials say could replace traditional eye patches. CureSight provides cloud-based monitoring for caregivers and doctors while the child watches whatever content they want from the comfort of their own home.
The trial is the first of its kind in children against the gold standard treatment for lazy eyes, the startup noted. It recruits 90 children with amblyopia aged 4 to 9 years. It takes place at six different medical centers in Israel, including Sheba Medical Center, where a previous trial observed improvements in visual and stereo acuity with 95% adhesion in 20 children between the ages of 4 and 15. .
CEO Ran Yam explains, “We are excited to launch this important trial, which is essential to demonstrate how effective our lazy eye treatment is while being fun and engaging for the patient,” said NovaSight CEO Ran Yam. , in the press release. “Our CureSight treatment enables children to enjoy a wide variety of content such as TV shows, movies and social media from their homes while treating and improving their vision.
“This is another important step in our journey to bring a revolutionary treatment for lazy eyes to children around the world. “