VR for Amblyopia May Benefit Wider Range of Children

TOPLINE:

Luminopia, a software system approved by the US Food and Drug Administration to treat amblyopia by modifying TV shows and movies in virtual reality (VR) headsets, is improving visual acuity for children in a real-world registry, including patients who would not have met criteria for inclusion in an earlier phase 3 trial of the therapy, according to research presented at the 2024 annual meeting of the American Academy of Ophthalmology (AAO). Children who have already received other treatments, and 8- to 12-year-olds, are among the new patient groups in the study.

METHODOLOGY:

• Researchers analyzed data from 209 patients with amblyopia in the United States who were enrolled in the Patients Using Prescription Luminopia Registry.
• They categorized patients based on amblyopia severity and measured changes in visual acuity over 24 weeks.
• In the phase 3 trial, patients were aged 4-7 years, and outcomes were assessed after 12 weeks. Binocular therapy received clearance from the US Food and Drug Administration in 2021.

TAKEAWAY:

• Improvement in visual acuity was observed in subgroups by age, prior treatment for amblyopia, type of amblyopia, and severity of the condition.
• Patients with severe amblyopia showed improvement in logMAR best-corrected visual acuity from 0.84 at baseline to 0.68 at 12 weeks and 0.59 at 24 weeks.
• Patients with moderate amblyopia experienced an improvement in visual acuity from 0.41 at baseline to 0.33 at 12 weeks and 0.32 at 24 weeks.
• For patients with mild amblyopia, visual acuity changed from 0.15 at baseline to 0.11 at 12 weeks and 0.12 at 24 weeks.

IN PRACTICE:

“The registry shows that there is a positive real-world effect of Luminopia, with best corrected visual acuity improvement in multiple categories” beyond the scope of the phase 3 trial, said study author Brenda L. Bohnsack, MD, PhD, in her presentation at the meeting. “Further treatment beyond 12 weeks continues to show improvement, especially in those amblyopes that are severe.”

SOURCE:

Bohnsack, with Ann & Robert H. Lurie Children’s Hospital of Chicago, Illinois, presented the findings on October 19 at AAO 2024.

LIMITATIONS:

The study lacked a control group. The researchers said they plan to enroll 2000 patients in the registry. Future studies will examine how visual acuity changes after stopping treatment.

DISCLOSURES:

Bohnsack and some co-authors disclosed consulting for Luminopia, the company that markets the device. Another author, Eric D. Gaier, MD, PhD, with Harvard Medical School in Boston, disclosed owning shares of Luminopia and receiving royalty payments from the company.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.