N/A
N=117
Luminopia One Amblyopia Vision Improvement Study
Amblyopia
Bottom Line
View on ClinicalTrials.gov: NCT03608150 ↗Enrolled (actual)
117
Serious AEs
0.0%
Results posted
Mar 2024
Primary outcome: Primary: Best-Corrected Visual Acuity of Amblyopic Eye — 1.77; 0.85 Lines of visual acuity improvement
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Luminopia One (Device); Refractive Correction (Device)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Luminopia
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Best-Corrected Visual Acuity of Amblyopic Eye |
1.48; 0.95 | — |
| PRIMARY Best-Corrected Visual Acuity of Fellow Eye |
0.30; 0.17 | — |
| SECONDARY Adherence |
85 | — |
| SECONDARY Best-Corrected Visual Acuity of Amblyopic Eye |
1.48; 0.95 | — |
| SECONDARY Best-Corrected Visual Acuity of Amblyopic Eye |
1.48; 0.95 | — |
| SECONDARY Stereoacuity |
1.0; 0.8 | — |
Summary
The objective of the study is to demonstrate the safety and efficacy of Luminopia One in amblyopia patients with amblyopia associated with anisometropia and/or with mild strabismus.
Eligibility Criteria
Inclusion Criteria
- Age 4 to 7 years at the time of consent.
- Amblyopia associated with anisometropia and/or mild strabismus.
- Current refractive correction worn for at least 16 weeks or until 2 consecutive visual acuity measurements at least 8 weeks apart do not change by more than 1 logMAR lines.
- Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive.
- Fellow eye BCVA 20/32 or better.
- Interocular difference ≥ 3 logMAR lines.
- Heterotropia ≤ 5 prism diopters in current refractive correction at distance measured by SPCT.
Exclusion Criteria
- Atropine treatment in the past 2 weeks.
- Prior amblyopia treatment (other than refractive correction) for > 12 months in total.
- High myopia, previous intraocular / refractive surgery, severe ocular co-morbidities or development / cognitive delay.
- History of low adherence with amblyopia treatment or light-induced seizures.
Data sourced from ClinicalTrials.gov (NCT03608150). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.