Luminopia One Pilot Study
- Conditions
- Amblyopia
- Interventions
- Device: Luminopia One
- Registration Number
- NCT02782117
- Lead Sponsor
- Luminopia
- Brief Summary
A single-arm, multi-center, open-label pilot study to evaluate the feasibility, safety, and efficacy of the Luminopia One digital therapeutic in improving visual acuity in a pediatric amblyopia population.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 84
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Treatment Regimen A Luminopia One Treatment Regimen A will use the Luminopia device for an hour per day for 12 weeks.
- Primary Outcome Measures
Name Time Method Amblyopic eye best-corrected visual acuity 12 weeks Electronic ATS-HOTV protocol for participants \< 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age
- Secondary Outcome Measures
Name Time Method Amblyopic eye best-corrected visual acuity 4 weeks Electronic ATS-HOTV protocol for participants \< 7 years of age and electronic ETDRS protocol for participants ≥ 7 years of age
Adherence 12 weeks Duration spent using the device divided by duration of treatment prescribed (objectively monitored)
Trial Locations
- Locations (9)
Eye Physicians of Central Florida
🇺🇸Maitland, Florida, United States
Wheaton Eye Clinic
🇺🇸Chicago, Illinois, United States
Indiana University
🇺🇸Bloomington, Indiana, United States
Kids Eye Care of Maryland
🇺🇸Frederick, Maryland, United States
Children's Eye Care of Michigan
🇺🇸Dearborn, Michigan, United States
Conestoga Eye
🇺🇸Lancaster, Pennsylvania, United States
Virginia Pediatric Eye Center
🇺🇸Virginia Beach, Virginia, United States
Houston Eye Associates
🇺🇸Houston, Texas, United States
Concord Eye Center
🇺🇸Concord, New Hampshire, United States