Luminopia One Amblyopia Vision Improvement Study

Completed · Not applicable

Conditions studied: Amblyopia

In brief

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.

Key facts

Study ID

NCT03608150

Run by

Luminopia

People needed

117

Starts

2019-01-16

Expected to finish

2020-07-31

Last updated by the study team

2024-03-20

Who can join

Age: 4 and older, up to 7. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• UCLA Jules Stein Eye Institute — Los Angeles, California, United States
• Family Focus Eye Care — Gainesville, Florida, United States
• Eye Physicians of Central Florida — Maitland, Florida, United States
• Lurie Children's Hospital — Chicago, Illinois, United States
• IU School of Optometry — Bloomington, Indiana, United States
• Kids Eye Care of Maryland — Frederick, Maryland, United States
• Specialized Pediatric Eye Care — Beverly, Massachusetts, United States
• Children's Eye Care of Michigan — Dearborn, Michigan, United States
• Saint Louis University — St Louis, Missouri, United States
• University of Nebraska Medical Center — Omaha, Nebraska, United States
• Duke University — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• OSU College of Optometry — Columbus, Ohio, United States
• Pediatric Ophthalmology of Erie — Erie, Pennsylvania, United States
• Conestoga Eye — Lancaster, Pennsylvania, United States
• Children's Hospital Of Philadelphia — Philadelphia, Pennsylvania, United States
• Tri-County Eye Physicians — Southampton, Pennsylvania, United States
• Houston Eye Associates — Houston, Texas, United States
• Texas Children's Hospital (BCM) — Houston, Texas, United States
• Houston Eye Associates — Houston, Texas, United States
• Rocky Mountain Eye Care — Salt Lake City, Utah, United States
• Virginia Pediatric Eye Center — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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