Luminopia One Amblyopia Vision Improvement Study

Amblyopia Clinical Trial

Official title:

Luminopia One Amblyopia Vision Improvement Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03608150
• Other study ID #: C-AM-2
• Status: Completed
• Phase: N/A
• Start date: January 16, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: February 2024
• Source: Luminopia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Amblyopia

Intervention

Device:
• Luminopia One
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.
• Refractive Correction
Standard of care refractive correction (ex. spectacles)

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Luminopia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Adherence	Mean adherence with the therapeutic in treatment group.	12 weeks
Secondary	Best-Corrected Visual Acuity of Amblyopic Eye	Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 4 weeks using electronic ATS-HOTV protocol.	4 weeks
Secondary	Best-Corrected Visual Acuity of Amblyopic Eye	Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 8 weeks using electronic ATS-HOTV protocol.	8 weeks
Secondary	Stereoacuity	Mean stereoacuity improvement from baseline after 12 weeks.	12 weeks