Actively Recruiting
A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
Led by Jaeb Center for Health Research · Updated on 2026-02-11
238
Participants Needed
73
Research Sites
26 weeks
Total Duration
On this page
Sponsors
J
Jaeb Center for Health Research
Lead Sponsor
N
National Eye Institute (NEI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying children aged 4 to 7 years with amblyopia to compare two treatments: watching dichoptic movies or shows using the Luminopia headset versus patching the fellow eye. The goal is to see if the Luminopia headset treatment used one hour per day, six days per week, is not worse than patching for two hours per day, seven days per week, in improving vision in the amblyopic eye over 26 weeks. This phase 3 randomized trial evaluates changes in distance visual acuity as the primary outcome. Participants will be randomly assigned to one of two groups. One group uses the Luminopia headset to watch dichoptic content for one hour daily (which can be split into shorter sessions) six days a week, wearing optical correction if needed. The other group uses an eye patch on the fellow eye for two hours daily (also split into shorter sessions) seven days a week, with optical correction as needed. After 26 weeks, those initially in the patching group who still have significant vision difference may be offered the Luminopia treatment and followed for an additional 26 weeks. Throughout the study, participants will undergo clinical assessments at 13 and 26 weeks, with follow-up visits at 39 and 52 weeks for those switching to Luminopia. Researchers will measure changes in distance visual acuity in the amblyopic eye, tracking treatment effects over time. Parents will maintain communication with the study team, and participants will continue using required spectacles or contact lenses. The total study duration varies up to 52 weeks depending on treatment response and group assignment.
CONDITIONS
Brief Title
Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 4 to 7 years
- Amblyopic eye visual acuity between 20/40 and 20/200 inclusive
- Age-normal visual acuity in the fellow eye
- Interocular visual acuity difference of 3 or more logMAR lines
- Amblyopia caused by strabismus, anisometropia, or both
- No more than 2 weeks of prior dichoptic treatment
- No cycloplegic eyedrop treatment in the past 2 weeks
- Wearing required refractive correction based on recent cycloplegic refraction
- Willingness to wear the Luminopia headset
- Willingness to continue full-time spectacles or contact lens wear if needed
- Acceptance of random assignment to either treatment for 26 weeks
- Interpupillary distance between 52mm and 72mm
- Investigator agrees to prescribe treatment per protocol
- Parent understands protocol and accepts randomization
- Parent has phone access and agrees to contact
- No anticipated relocation outside study area within 52 weeks
You will not qualify if you...
- Heterotropia greater than 5 prism diopters at distance or near
- Need for prism lenses at enrollment
- Current bifocal spectacles (unless discontinued 2 weeks prior)
- Myopia worse than -6.00 diopters spherical equivalent in either eye
- Previous intraocular or refractive surgery
- Known skin reactions to patches or adhesives
- Ocular conditions reducing visual acuity (except nystagmus if vision criteria met)
- Diplopia occurring more than once per week in the last week
- History of light-induced seizures
- Severe developmental delay interfering with treatment or evaluation
- Prior participation in patching studies for amblyopia
- Immediate family member of study personnel or JAEB Center employees
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 26 weeks
Participants receive either dichoptic treatment using the Luminopia headset for 1 hour per day, 6 days a week, or patching treatment of the fellow eye for 2 hours per day, 7 days a week, both with optical correction if needed.
Clinical assessments at 13 and 26 weeks post-randomization
Duration - Up to 26 additional weeks
Participants initially assigned to patching with an interocular difference of 1 logMAR line or more at 26 weeks may begin Luminopia dichoptic therapy if they accept.
Clinical assessments at 39 and 52 weeks post-randomization
Trial Site Locations
Total: 73 locations
1
UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Midwestern University Eye Institute
Glendale, Arizona, United States, 85308
Actively Recruiting
3
Phoenix Children's Medical Group - Ophthalmology
Scottsdale, Arizona, United States, 85255
Actively Recruiting
4
University of Arizona
Tucson, Arizona, United States, 85711
Actively Recruiting
5
Arkansas Childrens
Little Rock, Arkansas, United States, 72202
Actively Recruiting
6
McFarland Eye Care Center
Little Rock, Arkansas, United States, 72205
Actively Recruiting
7
Univ. of California- Berkeley
Berkeley, California, United States, 94720
Actively Recruiting
8
Southern California College of Optometry
Fullerton, California, United States, 92831-1699
Actively Recruiting
9
Univ of California, Irvine- Gavin Herbert Eye Institute
Irvine, California, United States, 92697
Actively Recruiting
10
Children's Hospital of Los Angeles (CHLA)
Los Angeles, California, United States, 90027
Actively Recruiting
11
Jules Stein Eye Institute at the University of California, Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
12
Stanford University
Palo Alto, California, United States, 94303
Actively Recruiting
13
Western University College of Optometry
Pomona, California, United States, 91766
Actively Recruiting
14
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
15
Rady Children's Hospital - San Diego Dept of Ophthalmology
San Diego, California, United States, 92123
Actively Recruiting
16
University of California San Francisco Department of Ophthalmology
San Francisco, California, United States, 94143
Actively Recruiting
17
Yale University
New Haven, Connecticut, United States, 06511
Actively Recruiting
18
University of South Florida (USF) Eye
Tampa, Florida, United States, 33620
Actively Recruiting
19
The Emory Eye Center
Atlanta, Georgia, United States, 30322
Actively Recruiting
20
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
21
Illinois College of Optometry
Chicago, Illinois, United States, 60616
Actively Recruiting
22
Midwestern University Eye Institute
Downers Grove, Illinois, United States, 60515
Actively Recruiting
23
Progressive Eye Care
Lisle, Illinois, United States, 60532
Actively Recruiting
24
Indiana School of Optometry
Bloomington, Indiana, United States, 47405
Actively Recruiting
25
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
26
University of Kansas Dept of Ophthalmology
Prairie Village, Kansas, United States, 66208
Actively Recruiting
27
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204-5809
Actively Recruiting
28
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287-9028
Actively Recruiting
29
Specialized Pediatric Eye Care
Beverly, Massachusetts, United States, 01915
Actively Recruiting
30
New England College of Optometry
Boston, Massachusetts, United States, 02115
Actively Recruiting
31
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
32
Boston Children's Hospital Waltham
Boston, Massachusetts, United States, 02453
Actively Recruiting
33
University of Michigan
Ann Arbor, Michigan, United States, 48105
Actively Recruiting
34
Michigan College of Optometry at Ferris State Univ
Big Rapids, Michigan, United States, 49307
Actively Recruiting
35
Corewell Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
36
Pediatric Ophthalmology, P.C.
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
37
Children's Eye Care PC
West Bloomfield, Michigan, United States, 48322
Actively Recruiting
38
Zenith Vision Development Center
Duluth, Minnesota, United States, 55811
Actively Recruiting
39
University of Minnesota
Minneapolis, Minnesota, United States, 55454
Actively Recruiting
40
Mayo Clinic Department of Ophthalmology
Rochester, Minnesota, United States, 55905
Actively Recruiting
41
PineCone Vision Center
Sartell, Minnesota, United States, 56377
Actively Recruiting
42
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
43
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
44
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68114
Actively Recruiting
45
Ross Eye Institute, University of Buffalo, Med School Dept Ophthalmology
Buffalo, New York, United States, 14209
Actively Recruiting
46
NYU Langone Health
New York, New York, United States, 10017
Actively Recruiting
47
State University of New York, College of Optometry
New York, New York, United States, 10036
Actively Recruiting
48
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
49
Duke University Eye Center
Durham, North Carolina, United States, 27710
Actively Recruiting
50
University of North Dakota
Grand Forks, North Dakota, United States, 58202
Actively Recruiting
51
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
52
Cole Eye Institute
Cleveland, Ohio, United States, 44195
Actively Recruiting
53
Pediatric Ophthalmology Associates, Inc.
Columbus, Ohio, United States, 43205
Actively Recruiting
54
Ohio State University College of Optometry
Columbus, Ohio, United States, 43210-1280
Actively Recruiting
55
Rainbow Babies and Children's Hospital Dept of Ophth
Mayfield Heights, Ohio, United States, 44124
Actively Recruiting
56
Eye Care Associates, Inc.
Poland, Ohio, United States, 44514
Actively Recruiting
57
Casey Eye Institute
Portland, Oregon, United States, 97239
Actively Recruiting
58
Pediatric Ophthalmology of Erie
Erie, Pennsylvania, United States, 16501
Actively Recruiting
59
Conestoga Eye
Lancaster, Pennsylvania, United States, 17601
Actively Recruiting
60
Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
61
Pennsylvania College of Optometry, Salus at Drexel University
Philadelphia, Pennsylvania, United States, 19141
Actively Recruiting
62
Prisma Health
Columbia, South Carolina, United States, 29203
Actively Recruiting
63
Storm Eye Institute
Mt. Pleasant, South Carolina, United States, 29464
Actively Recruiting
64
Southern College of Optometry
Memphis, Tennessee, United States, 38104
Actively Recruiting
65
Vanderbilt Children's Hospital
Nashville, Tennessee, United States, 37232-8808
Actively Recruiting
66
Texas Children's Hospital - Dept. Of Ophthalmology
Houston, Texas, United States, 77030
Actively Recruiting
67
Texas Tech University Health Science Center
Lubbock, Texas, United States, 79430
Actively Recruiting
68
University of the Incarnate Word
San Antonio, Texas, United States, 78209
Actively Recruiting
69
Earl R. Crouch, III
Norfolk, Virginia, United States, 23502-3942
Actively Recruiting
70
Virginia Pediatric Eye Center
Norfolk, Virginia, United States, 23502
Actively Recruiting
71
Seattle Children's Hospital, University of Washington
Seattle, Washington, United States, 98105
Actively Recruiting
72
Spokane Eye Clinical Research
Spokane, Washington, United States, 99204
Actively Recruiting
73
Gundersen Health System
La Crosse, Wisconsin, United States, 54601
Actively Recruiting
Research Team
R
Raymond T Kraker, MSPH
B
Brooke P Fimbel
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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