Luminopia One digital therapeutic may be effective in children with amblyopia
A dichoptic digital therapeutic from Luminopia plus full-time glasses improved vision in children with amblyopia compared with full-time glasses alone, according to a pivotal phase 3 randomized controlled trial in Ophthalmology.
“Luminopia’s efforts to rethink treatment for children with amblyopia are very promising,” Gil Binenbaum, MD, MSCE, a pediatric ophthalmologist and advisor to Luminopia, said in a press release. “Patching is often ineffective due to poor adherence, as any parent who has tried to patch their child’s eye knows. In addition, current treatment options don’t encourage patients to use both eyes together. Luminopia One addresses both of these problems.”
Between Jan. 16, 2019, and Jan. 15, 2020, 105 children with amblyopia, aged 4 to 7 years, were randomly assigned to the treatment group or the control group; 45 participants in each group were included in the final analysis.
In the treatment group, participants used the device to watch TV shows or movies for 1 hour a day, 6 days a week, for 12 weeks and wore glasses full time. The control group wore glasses full time only.
Baseline mean amblyopic eye visual acuity was similar between the treatment group (0.54 ± 0.21 logMAR) and the control group (0.50 ± 0.19 logMAR).
After 12 weeks, visual acuity in the amblyopic eye in the treatment group and the control group improved by 1.8 lines and 0.8 lines, respectively. The 1-line difference between the groups was significant (P = .0011).
In addition, the proportion of patents with amblyopic eye visual acuity improvement of 2 lines or greater was 62% in the treatment group and 33% in the control group (P = .006).
No significant difference was found in stereoacuity improvement between the groups.
Serious adverse events were not reported, but nonserious adverse events such as worsening visual acuity, headaches and new heterotropias were reported in 19.6% of the treatment group and 13% of the control group.
Among 36 participants who tried patching before, 34 parents (94%) said they would “likely” or “very likely” opt for therapeutic treatment instead of patching.
“The data from this pivotal trial validate Luminopia One as a safe and effective potential new treatment option for amblyopia in young children,” study co-author Robert Langer, ScD, Luminopia board director, said in the release. “These positive data also illustrate the potential of digital therapeutics as a new class of treatments for serious diseases.”
Limitations included comparison to refractive correction only, study length, effects of stopping previous amblyopia treatment and lack of follow-up data for 15 participants.
“Future studies could evaluate refinements to the therapeutic design, the impact of dosing, efficacy compared to other current treatments, efficacy in older patient populations, safety in a larger sample and durability of benefit,” the study authors wrote.
Reference:
- Luminopia One, a digital therapeutic for amblyopia, demonstrates safety and efficacy in phase 3 pivotal trial. https://www.businesswire.com/news/home/20210914005661/en/Luminopia-One-a-Digital-Therapeutic-for-Amblyopia-Demonstrates-Safety-and-Efficacy-in-Phase-3-Pivotal-Trial. Published Sept. 14, 2021. Accessed Sept. 17, 2021.
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