Luminopia One Pilot Study
NCT02782117 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84
Last updated 2020-07-09
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.
Conditions
- Amblyopia
Interventions
- DEVICE
-
Luminopia One
Luminopia One is a digital therapeutic that allows patients to watch videos with therapeutic modifications applied.
Sponsors & Collaborators
- collaborator OTHER
-
Luminopia
lead INDUSTRY
Principal Investigators
-
David Hunter, MD PhD · Boston Children's Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 4 Years
- Max Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-08-01
- Primary Completion
- 2019-02-06
- Completion
- 2019-02-06
- FDA Device
- Yes
Countries
- United States
Study Locations
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