Airport City, Israel–based NovaSight’s pivotal trial has the company on track to achieving FDA 510(k) approval for the CureSight device, according to a news release.
CureSight is an eye-tracking-based lazy eye treatment that NovaSight officials think could replace traditional eye patching. CureSight provides cloud monitoring to caregivers and physicians while the child watches their content of choice from the comfort of their own home.
The trial is the first of its kind in children against the gold standard patching treatment for lazy eye, the startup noted. It is recruiting 90 children with amblyopia aged 4 to 9. It is taking place across six different medical centers in Israel, including Sheba Medical Center, where a previous trial observed visual and stereo acuity improvements with 95% adherence in 20 children between four and 15.
CEO Ran Yam explains, “We’re delighted with the initiation of this important trial, key in demonstrating how effective our lazy eye treatment is while being fun and engaging for the patient,” NovaSight CEO Ran Yam said in the release. “Our CureSight treatment allows children to enjoy a wide variety of content like TV programs, movies, and social media from home while treating and improving their vision.
“This is another important step on our journey of bringing revolutionary treatment for lazy eye to children everywhere.”