NovaSight has reported positive data from a pivotal trial of its eye-tracking based digital treatment device, CureSight, for the treatment of amblyopia, which is commonly known as ‘lazy eye’.
The digital device is designed to train the visual system to use both eyes equally while watching any streamed video through red-blue treatment glasses.
CureSight uses algorithms and eye-tracking technology to blur the image’s centre of vision shown to the strong eye through real-time image processing, encouraging the amblyopic eye to work with the stronger eye as a team.
It can be used at home and shares treatment reports with caregivers through a Cloud portal.
The randomised, multicentre, controlled pivotal clinical trial was conducted on 103 subjects aged four to nine years in six medical centres, including Sheba Medical Center in Tel Aviv, Israel.
In the trial, participants were randomised and the improvement in visual outcomes achieved through treatment with CureSight digital was compared with eye patching, the existing gold-standard-of-care treatment for amblyopia.
The study’s top-line analyses showed that the improvement of Best Corrected Visual Acuity (BCVA) at week 16 was high in the CureSight digital treatment group versus the eye patching group.
NovaSight stated that the pivotal trial also assessed adherence and patient satisfaction.
NovaSight CEO Ran Yam said: “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.”
The company said that the completion of the CureSight pivotal trial represents a significant step towards securing approval from the US Food and Drug Administration (FDA), following the device’s receipt of CE mark.