Visual acuity, stereoacuity maintained 1 year after treatment with CureSight for amblyopia
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Key takeaways:
- Improvements in stereoacuity and binocular visual acuity were maintained at 12 weeks and 1 year.
- Amblyopia recurrence was reported in 5.3% of children at 12 weeks and 20.4% at 1 year.
Improvements in visual acuity and stereoacuity were maintained 1 year after binocular treatment with CureSight among children with amblyopia, according to a follow-up study published in American Journal of Ophthalmology.
“Previously, the CureSight study results showed that binocular treatment was noninferior to patching following 16 weeks of treatment in children aged 4 to younger than 9 years,” Oren Yehezkel, PhD, study author and chief scientific officer at NovaSight, told Healio. “Here, in a follow-up study, we report that the treatment gains both in the amblyopic eye visual acuity and in stereoacuity were maintained for 1 year without any treatment. The CureSight allows eye care providers to prescribe an additional treatment option for amblyopia.”
As Healio previously reported, CureSight (NovaSight) is a digital therapy device for amblyopia that uses eye-tracking technology to train both eyes to work together while the user watches streamed video content. The device received 510(k) clearance from the FDA in 2022.
In a long-term prospective, nonrandomized follow-up study, 38 of the 43 children with amblyopia (mean age at baseline, 6.8 years; 55% girls) who were successfully treated in the first 16-week CureSight study were evaluated 12 weeks after treatment for visual acuity, stereoacuity and amblyopia recurrence. In addition, 27 children were evaluated 1 year after treatment.
At 12 weeks, there was no significant change from end-of-treatment results in mean improvement in amblyopic eye visual acuity, which was maintained at 0.27 ± 0.14 logMAR compared with baseline.
At 52 weeks, there was a partial reduction in amblyopic eye visual acuity gain of 0.06 ± 0.1 logMAR compared with end-of-treatment results, but a statistically significant residual gain of 0.2 ± 0.14 logMAR compared with baseline.
In addition, median improvement in stereoacuity and binocular visual acuity were maintained at 12 weeks and 52 weeks after treatment. Amblyopia recurrence was reported in 5.3% of participants at 12 weeks and 20.4% of participants at 52 weeks, which researchers noted was “comparable” to rates reported in literature.
“This study shows that the ability to use any streamed content during treatment supports higher adherence rates and user satisfaction, thereby providing an additional first-in-line alternative to traditional amblyopia treatment,” Yehezkel told Healio. “These findings merit future studies in older children and adults with longer treatment regimens and different treatment.”
According to a related press release, the company plans to initiate a full commercial launch of CureSight in the U.S. in 2024, concurrent with a commercial launch in Europe and China.
Reference:
- NovaSight announces publication of CureSight’s pivotal study of one-year follow-up outcomes. https://www.newswire.com/news/novasight-announces-publication-of-curesight-s-pivotal-study-of-one-22266017. Published March 13, 2024. Accessed March 18, 2024.
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