Recent analyses from the PUPiL Registry, that were presented at the American Association for Pediatric Ophthalmology and Strabismus 51st Annual Meeting, provide new data on the real-world use of Luminopia, a binocular, dual-mechanism digital therapeutic for amblyopia. “The treatment utilizes contrast reduction and dichoptic masking overlayed on patient-selected programming,” the first study described.¹ The company describes it as a virtual reality headset that streams children’s shows from Nickelodeon, PBS Kids, Sesame Street, DreamWorks, Pokémon, and more. Treatment is 1 hour a day for 6 days a week.

Further research is needed to explore mechanisms and observations, but Luminopia showed meaningful visual acuity improvement and durability. It may also address limitations such as low visual function of the unoccluded eye, lengthy daily treatment durations, and low adherence rates in occlusion therapy, and high recurrence rates within 1 year of treatment cessation with traditional monocular and digital eye-tracking treatments.

Study 1: Visual Acuity Improvements

“Real-World Effectiveness of a Binocular, Dual-Mechanism Therapy in Severe Amblyopia: Analysis from the PUPiL Registry” by Courtney L. Kraus, MD, of the Wilmer Eye Institute at Johns Hopkins University School of Medicine in Baltimore, and colleagues evaluated outcomes in 57 children under 18 years of age with severe amblyopia (best-corrected visual acuity [BCVA] 20/100 or worse) following Luminopia treatment. The mean age of the cohort was 7.1±2.6 years and participants completed an average of 166 treatment hours over 11.8 months.¹

Mean BCVA improved by 1.8 lines (95% CI: 1.0–2.6), and 46% of patients achieved gains of at least 2 lines. The researchers observed greater improvements among treatment-naïve patients (4.4 lines; 95% CI: 2.1–6.7) compared with those who were previously treated (1.5 lines; 95% CI: 0.6–2.3; P=.0183).¹

Correlation analyses showed that worse baseline BCVA (r=.33, P=.013) and more cumulative treatment hours (r=.51, P<.001) were associated with greater improvement. Age and amblyopia type were not significantly associated with outcomes.¹

Study 2: Durability and Recurrence After Treatment

In “Visual Acuity Gains Maintained with Dual-Mechanism Digital Treatment in Children with Unilateral Amblyopia: PUPiL Registry Results”, Brenda Bohnsack, MD, PhD, and colleagues examined visual acuity maintenance following completion of therapy in 60 children (mean age 7.2±2.5 years), 80% of whom had prior amblyopia treatment. Patients completed an average of 103±76 hours of therapy over 7.0±2.9 months.²

After 6.2±3.1 months off treatment, mean BCVA remained stable at 1.7 lines (95% CI: 1.2–2.2), but improved by 1.4 lines (95% CI: 1.0–1.8) from baseline at the end of treatment. Amblyopia recurrence, defined as a loss of 2 or more lines, occurred in 3.3% of patients (2/60). This recurrence rate is lower than other treatments at 6 months posttreatment, Dr. Bohnsack and colleagues noted.²

Subgroup analyses showed similar outcomes in children younger than 7 years and those aged 7 years or older (P≥.6). Treatment-naïve patients had greater improvement (3.0±1.9 lines) compared with previously treated patients (1.0±1.2 lines; P<.0001), as well as continued improvement posttreatment (+0.6 lines; P=.04) while previously treated patients remained stable (+0.2 lines; P=.32). Patients who have severe amblyopia had greater gains (2.6±1.9 lines) vs moderate amblyopia (1.1±1.4 lines; P=.0015), and they experienced continued improvement after treatment (P=.017).²

Study 3: Comparison With IRIS Registry Benchmarks

Researchers compared real-world outcomes from 56 children aged 3 to 12 years who were treated with Luminopia for at least 12 weeks to IRIS Registry benchmarks.³

Mean baseline amblyopic eye visual acuity was 0.42±0.23 logMAR, and mean improvement was 1.91 lines (95% CI: 1.37–2.46) over an average of 41.9 weeks of device use. When stratified by age, children aged 3 to 6 years (n=30) showed 1.90 lines improvement (95% CI: 1.29–2.51), while children aged 7 to 12 years (n=26) showed 1.93 lines improvement (95% CI: 0.94–2.93). These outcomes were comparable to IRIS Registry benchmarks for younger children (1.8 lines) and exceeded benchmarks for older children (0.9 lines). Improvement was strongly correlated with worse baseline visual acuity (r = -.63, P<.0001), but not with age (r=0.09, P=.53). Of the 56 children enrolled, 30% were girls.³

Overall

According to the company, the treatment had 85% compliance (median percentage of total treatment completed), and there were no serious side effects reported. Rates of ocular side effects were similar between treatment and control groups. The most common adverse event was headaches (14.3% of treatment patients vs 1.7% of controls) that were graded as mild and transient. They also report that cases of new or worsening eye turn are balanced between treatment (7.1%) and control (8.5%) groups.

Luminopia is currently FDA-cleared for use in children between 4 and 12 years old.

References

1. Indaram M, Kraus CL, Godfrey AA, et al. Real-world fffectiveness of a binocular, dual-mechanism therapy in severe amblyopia: analysis from the PUPiL Registry. Presented at: American Association for Pediatric Ophthalmology and Strabismus 2026 Annual Meeting; March 18-22, 2026; Boston, Massachusetts.
2. Bohnsack B, Ghasia F, Hancock S, Warner N, Gaier E. Visual acuity gains maintained with dual-mechanism digital treatment in children with unilateral amblyopia: PUPiL Registry results. Presented at: American Association for Pediatric Ophthalmology and Strabismus 2026 Annual Meeting; March 18-22, 2026; Boston, Massachusetts.
3. Comparison of amblyopia outcomes with a digital therapeutic among children 3 to 12 years of age in clinical practice compared with IRIS Registry Benchmarks.Presented at: American Association for Pediatric Ophthalmology and Strabismus 2026 Annual Meeting; March 18-22, 2026; Boston, Massachusetts.