TUESDAY, May 10, 2022 (HealthDay News) -- A novel, at-home system for treating amblyopia (lazy eye) in children may be an effective and acceptable alternative to patching, with improvements in visual acuity and binocularity and satisfaction among child users and parents, according to a study presented at the Association for Research in Vision and Ophthalmology Annual Meeting, held May 1 to 4 in Denver.
"Living in the digital age also requires modification to traditional patient care," Oren Yehezkel, Ph.D., of NovaSight Ltd. In Israel, told Elsevier's PracticeUpdate. "Patching – the gold standard of amblyopia treatment – though effective, has inherent shortcomings such as low adherence and discomfort. However, binocular therapy with CureSight™ is a real alternative to patching, as it is a fun and engaging treatment, done in the comfort of the patient’s home with an unlimited variety of streamed content that the child loves."
The researchers conducted a randomized controlled trial to evaluate the safety and efficacy of the CureSight binocular eye-tracking-based device. The analysis included 103 children, ages 4 to 9 years, with anisometropic, strabismic, or mixed amblyopia. Participants were randomly assigned to either watch internet content of their choice on the CureSight screen five times a week for 90 minutes or undergo 120 minutes of patching for seven days a week over 16 weeks.
The CureSight system is based on the child watching any internet content of his choice on a tablet through special anaglyph glasses over any habitual correction spectacles. The system presents overlapping images with the center of the image for the good eye blurred to a visual acuity of two lines below the acuity of the nonamblyopic eye for binocular stimulation. A 90-Hz eye tracker identifies the gaze position of each eye to provide accurate compliance monitoring. Only the time when the patient is actually fixating on the screen counts as patient compliance.
The researchers found that the digital treatment device was noninferior to an eye patch with improvements seen in both visual acuity and binocularity. Results were defined as “favorable” for the 87 completed individuals at the 16-week follow-up visit. Additionally, in a usability study with 15 pediatric users and their guardians, there was a mean adherence of 93 percent of the prescribed time. Parents' satisfaction was also very high with 95 percent of patients’ guardians answering that they were likely or very likely to prefer CureSight over patching.
"As a remote treatment, it was important for us to provide an end-to-end service for both the patients and the physicians," explained Yehezkel. "Behind the scenes, there is a dedicated monitoring center that is observing the patient’s treatment progress and compliance. In cases of low compliance, the monitoring center contacts the patient’s guardians to ensure the child proceeds with the treatment according to the regimen, which takes some of the burden off the prescribing physician's shoulders."
Prescribing physicians also have access to the cloud platform, providing them with the freedom to monitor patients’ progress remotely, which saves both the patient and clinician the time of an unnecessary office visit.
Yehezkel told Elsevier's PracticeUpdate that NovaSight, the maker of the CureSight platform, is submitting the pivotal study results to the U.S. Food and Drug Administration for 510(k) clearance, with the expectation of a decision by the end of the year. The company is planning a U.S. launch and plans to translate the three unique CPT codes already granted to the CureSight treatment into actual coverage by both the Centers for Medicare and Medicaid Services and private payers.
Additionally, Yehezkel said, NovaSight is planning to initiate a larger study to expand the indication to adults based on the promising findings of a recently concluded feasibility study.
Several authors report financial ties to NovaSight, the maker of the CureSight binocular treatment.