Luminopia One Amblyopia Vision Improvement Study
1 other identifier
interventional
117
1 country
22
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 12, 2018
CompletedFirst Posted
Study publicly available on registry
July 31, 2018
CompletedStudy Start
First participant enrolled
January 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedResults Posted
Study results publicly available
March 20, 2024
CompletedMarch 20, 2024
February 1, 2024
1.5 years
July 12, 2018
April 4, 2022
February 24, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Best-Corrected Visual Acuity of Amblyopic Eye
Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.
12 weeks
Best-Corrected Visual Acuity of Fellow Eye
Mean improvement in best-corrected visual acuity of fellow eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.
12 weeks
Secondary Outcomes (4)
Adherence
12 weeks
Best-Corrected Visual Acuity of Amblyopic Eye
4 weeks
Best-Corrected Visual Acuity of Amblyopic Eye
8 weeks
Stereoacuity
12 weeks
Study Arms (2)
Therapeutic Group
EXPERIMENTALParticipants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks.
Control Group
ACTIVE COMPARATORParticipants assigned to the control group will wear their current refractive correction full-time for 12 weeks.
Interventions
Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Luminopialead
Study Sites (22)
UCLA Jules Stein Eye Institute
Los Angeles, California, 90095, United States
Family Focus Eye Care
Gainesville, Florida, 32605, United States
Eye Physicians of Central Florida
Maitland, Florida, 32751, United States
Lurie Children's Hospital
Chicago, Illinois, 60611, United States
IU School of Optometry
Bloomington, Indiana, 47405, United States
Kids Eye Care of Maryland
Frederick, Maryland, 21703, United States
Specialized Pediatric Eye Care
Beverly, Massachusetts, 01915, United States
Children's Eye Care of Michigan
Dearborn, Michigan, 48124, United States
Saint Louis University
St Louis, Missouri, 63104, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
Duke University
Durham, North Carolina, 27708, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
OSU College of Optometry
Columbus, Ohio, 43210, United States
Pediatric Ophthalmology of Erie
Erie, Pennsylvania, 16501, United States
Conestoga Eye
Lancaster, Pennsylvania, 17601, United States
Children's Hospital Of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Tri-County Eye Physicians
Southampton, Pennsylvania, 18966, United States
Houston Eye Associates
Houston, Texas, 77025, United States
Texas Children's Hospital (BCM)
Houston, Texas, 77030, United States
Houston Eye Associates
Houston, Texas, 77381, United States
Rocky Mountain Eye Care
Salt Lake City, Utah, 84107, United States
Virginia Pediatric Eye Center
Virginia Beach, Virginia, 23452, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
We evaluated the therapeutic alongside continued refractive correction alone over 12 weeks and we did not compare with patching or atropine penalization, so we do not know the relative safety and efficacy of the therapeutic versus patching or atropine, nor the durability of benefit from the therapeutic. The duration of our study was limited to 12 weeks, which may have biased the results toward superiority of one treatment over the other depending on the time course of responses.
Results Point of Contact
- Title
- VP of Clinical Development
- Organization
- Luminopia, Inc.
Study Officials
- STUDY DIRECTOR
Scott Xiao
Luminopia
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 12, 2018
First Posted
July 31, 2018
Study Start
January 16, 2019
Primary Completion
July 31, 2020
Study Completion
July 31, 2020
Last Updated
March 20, 2024
Results First Posted
March 20, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will not share