The study, which randomized 103 participants aged 4 to 9, compared the improvement in visual outcomes achieved by CureSight digital treatment versus eye patching—the current gold-standard-of-care treatment.
This is the first-ever pivotal study in which a digital device was shown to be noninferior to eye patching for amblyopia treatment in children.
In addition to achieving the noninferiority primary endpoint, the topline analyses from the pivotal study demonstrated that Best Corrected Visual Acuity (BCVA) improvement at week 16 was larger in the treatment group compared to the patching control group.
In addition, a significant stereo acuity improvement was observed in both groups. No serious adverse events were observed in either treatment arms (CureSight or patching) and all non-serious adverse events were transient and self-limiting.
The study also evaluated adherence and patient satisfaction. The mean adherence to CureSight use during the study among subjects evaluated at the week 16 visit (N=43) was 93%, as measured by the CureSight's eye tracking system. In addition, 93% of parents reported that they are likely or very likely to choose the CureSight digital treatment over patching.
The pivotal clinical study was conducted in six medical centers.
"We are delighted to have completed the CureSight study and further validate its safety and effectiveness as measured by visual acuity and stereoacuity improvement in comparison to patching and with a high safety profile and user satisfaction,” NovaSight CEO Ran Yam said in a company news release.
“Eye patching is effective when patients are compliant, however, patching is often associated with insufficient adherence due to the discomfort it brings to the patient and the social stigma that many children experience when wearing a patch.”