Digital amblyopia treatment device noninferior to eye patching in study
CureSight, a digital treatment device, was noninferior to eye patching for pediatric amblyopia in a pivotal clinical study, NovaSight announced in a press release.
The multicenter randomized controlled trial compared the eye tracking-based device with patching in 103 subjects between the ages of 4 and 9 years. The device, which trains the visual system to use both eyes simultaneously, was noninferior to the current standard of care.
In addition, participants treated with CureSight experienced a greater improvement in best corrected visual acuity after 16 weeks. No serious adverse events were observed in either group.
Among 43 subjects who underwent evaluation at 16 weeks, the mean adherence to treatment was 93%.
“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,” NovaSight CEO Ran Yam said in the release. “The success of the CureSight study is a critical step toward bringing this treatment for lazy eye to children around the world and to potentially modernizing the standard of care.”
CureSight has received CE mark approval in Europe, and NovaSight is preparing to submit an application for 510(k) clearance of the device to the FDA.