Digital treatment device non-inferior to eye patch for amblyopia treatment
An eye-tracking based, digital treatment device was shown to be non-inferior to eye patching for the treatment of amblyopia in children for the first time, according to positive pivotal data from a multicenter, randomized, controlled trial.
The study randomized 103 children between the ages of 4 and 9 years to CureSight (NovaSight) digital treatment or the current gold-standard-of-care treatment to compare visual outcomes.
According to an analysis from the study, Best Corrected Visual Acuity (BCVA) improvement was larger in the treatment groups at week 16.
Patient adherence measured by the eye tracking systems showed a mean adherence to CureSight of 93% at week 16. Most parents (93%) also reported that they are likely or very likely to choose the CureSight digital treatment over patching.
“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. 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,” said NovaSight CEO Ran Yam in a press 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.”
Read the full press release here.