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Luminopia One Amblyopia Vision Improvement Study

Primary Purpose

Amblyopia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Luminopia One
Refractive Correction
Sponsored by
Luminopia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Amblyopia

Eligibility Criteria

4 Years - 7 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA Jules Stein Eye Institute
  • Family Focus Eye Care
  • Eye Physicians of Central Florida
  • Lurie Children's Hospital
  • IU School of Optometry
  • Kids Eye Care of Maryland
  • Specialized Pediatric Eye Care
  • Children's Eye Care of Michigan
  • Saint Louis University
  • University of Nebraska Medical Center
  • Duke University
  • Cleveland Clinic
  • OSU College of Optometry
  • Pediatric Ophthalmology of Erie
  • Conestoga Eye
  • Children's Hospital Of Philadelphia
  • Tri-County Eye Physicians
  • Houston Eye Associates
  • Texas Children's Hospital (BCM)
  • Houston Eye Associates
  • Rocky Mountain Eye Care
  • Virginia Pediatric Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Therapeutic Group

Control Group

Arm Description

Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks.

Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Adherence
Mean adherence with the therapeutic in treatment group.
Best-Corrected Visual Acuity of Amblyopic Eye
Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 4 and 8 weeks using electronic ATS-HOTV protocol.
Stereoacuity
Mean stereoacuity improvement from baseline after 4, 8, and 12 weeks.

Full Information

First Posted
July 12, 2018
Last Updated
September 9, 2020
Sponsor
Luminopia
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1. Study Identification

Unique Protocol Identification Number
NCT03608150
Brief Title
Luminopia One Amblyopia Vision Improvement Study
Official Title
Luminopia One Amblyopia Vision Improvement Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Luminopia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
117 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Therapeutic Group
Arm Type
Experimental
Arm Description
Participants assigned to the therapeutic group will be prescribed Luminopia One for 1 hour per day, 6 days per week for 12 weeks.
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Participants assigned to the control group will wear their current refractive correction full-time for 12 weeks.
Intervention Type
Device
Intervention Name(s)
Luminopia One
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Refractive Correction
Intervention Description
Standard of care refractive correction (ex. spectacles)
Primary Outcome Measure Information:
Title
Best-Corrected Visual Acuity of Amblyopic Eye
Description
Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.
Time Frame
12 weeks
Title
Best-Corrected Visual Acuity of Fellow Eye
Description
Mean improvement in best-corrected visual acuity of fellow eye from baseline after 12 weeks of treatment using electronic ATS-HOTV protocol.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Adherence
Description
Mean adherence with the therapeutic in treatment group.
Time Frame
4, 8, and 12 weeks
Title
Best-Corrected Visual Acuity of Amblyopic Eye
Description
Mean improvement in best-corrected visual acuity of amblyopic eye from baseline after 4 and 8 weeks using electronic ATS-HOTV protocol.
Time Frame
4 and 8 weeks
Title
Stereoacuity
Description
Mean stereoacuity improvement from baseline after 4, 8, and 12 weeks.
Time Frame
4, 8, and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott Xiao
Organizational Affiliation
Luminopia
Official's Role
Study Director
Facility Information:
Facility Name
UCLA Jules Stein Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Family Focus Eye Care
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32605
Country
United States
Facility Name
Eye Physicians of Central Florida
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Lurie Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
IU School of Optometry
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47405
Country
United States
Facility Name
Kids Eye Care of Maryland
City
Frederick
State/Province
Maryland
ZIP/Postal Code
21703
Country
United States
Facility Name
Specialized Pediatric Eye Care
City
Beverly
State/Province
Massachusetts
ZIP/Postal Code
01915
Country
United States
Facility Name
Children's Eye Care of Michigan
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
OSU College of Optometry
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Pediatric Ophthalmology of Erie
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16501
Country
United States
Facility Name
Conestoga Eye
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17601
Country
United States
Facility Name
Children's Hospital Of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Tri-County Eye Physicians
City
Southampton
State/Province
Pennsylvania
ZIP/Postal Code
18966
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77025
Country
United States
Facility Name
Texas Children's Hospital (BCM)
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Houston Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77381
Country
United States
Facility Name
Rocky Mountain Eye Care
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Virginia Pediatric Eye Center
City
Virginia Beach
State/Province
Virginia
ZIP/Postal Code
23452
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Luminopia One Amblyopia Vision Improvement Study

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