Clinical trial NCT03608150: Luminopia One Amblyopia Vision Improvement Study
Official title: Luminopia One Amblyopia Vision Improvement Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amblyopia
Lead sponsor: Luminopia
Sponsor class: INDUSTRY
First posted: 2018-07-31
Enrollment: 117
Sex: ALL
Minimum age (years): 4
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: The proposed study is a multi-center randomized controlled clinical trial which compares the mean change in amblyopic eye Best Corrected Visual Acuity from baseline with Luminopia One ("therapeutic") to refractive correction ("control"). One-hundred and forty participants (n = 140) aged 4-7 years will be enrolled. Participants will be randomized 1:1 to the "therapeutic group ", to use Luminopia One, or the "control group", to undergo continued refractive correction, for 12 weeks of treatment.

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.

Primary outcomes:
measure: Best-Corrected Visual Acuity of Amblyopic Eye
timeFrame: 12 weeks
measure: Best-Corrected Visual Acuity of Fellow Eye
timeFrame: 12 weeks
Secondary outcomes:
measure: Adherence
timeFrame: 12 weeks
measure: Best-Corrected Visual Acuity of Amblyopic Eye
timeFrame: 4 weeks
measure: Best-Corrected Visual Acuity of Amblyopic Eye
timeFrame: 8 weeks
measure: Stereoacuity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Jules Stein Eye Institute
state: California
city: Gainesville
country: United States
facility: Family Focus Eye Care
state: Florida
city: Maitland
country: United States
facility: Eye Physicians of Central Florida
state: Florida
city: Chicago
country: United States
facility: Lurie Children's Hospital
state: Illinois
city: Bloomington
country: United States
facility: IU School of Optometry
state: Indiana
city: Frederick
country: United States
facility: Kids Eye Care of Maryland
state: Maryland
city: Beverly
country: United States
facility: Specialized Pediatric Eye Care
state: Massachusetts
city: Dearborn
country: United States
facility: Children's Eye Care of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis University
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: OSU College of Optometry
state: Ohio
city: Erie
country: United States
facility: Pediatric Ophthalmology of Erie
state: Pennsylvania
city: Lancaster
country: United States
facility: Conestoga Eye
state: Pennsylvania
city: Philadelphia
country: United States
facility: Children's Hospital Of Philadelphia
state: Pennsylvania
city: Southampton
country: United States
facility: Tri-County Eye Physicians
state: Pennsylvania
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital (BCM)
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Salt Lake City
country: United States
facility: Rocky Mountain Eye Care
state: Utah
city: Virginia Beach
country: United States
facility: Virginia Pediatric Eye Center
state: Virginia
Study officials:
affiliation: Luminopia
name: Scott Xiao
role: STUDY_DIRECTOR
References: