Actively Recruiting
A Randomized Trial of Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
Led by Jaeb Center for Health Research · Updated on 2026-02-11
252
Participants Needed
58
Research Sites
17 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 evaluating dichoptic treatments for children aged 8 to 12 years with amblyopia, a condition affecting vision. This phase 3 randomized trial compares two types of virtual reality-based dichoptic therapy, Luminopia and Vivid Vision, against continued use of optical correction alone. The study aims to understand how these treatments impact vision improvement, specifically measuring changes in the amblyopic eye's visual acuity. Participants are randomly assigned to one of three groups: Luminopia, involving watching dichoptic movies or shows using a headset for 1 hour daily six days a week; Vivid Vision, playing dichoptic video games with a headset for about 25 minutes daily six days a week; or continuing optical correction with glasses or contact lenses alone. Those initially assigned to optical correction alone who show limited improvement after 18 weeks may be re-randomized to receive one of the dichoptic therapies, with follow-up visits extending to 36 weeks. During the study, participants attend clinical assessments at 9 and 18 weeks after starting treatment, with additional visits at 27 and 36 weeks for some. Researchers measure visual acuity changes in the amblyopic eye using the logMAR scale and assess quality of life related to vision through a pediatric eye questionnaire. The study includes monitoring adherence to treatment, willingness to wear the headset and optical correction, and safety considerations throughout the 18 to 36-week participation period.
CONDITIONS
Brief Title
Dichoptic Treatment for Amblyopia in Children 8 to 12 Years of Age
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 8 and less than 13 years
- Visual acuity in the amblyopic eye from 20/40 to 20/200 inclusive
- Visual acuity in the fellow eye 20/25 or better
- Interocular difference of 3 or more logMAR lines (at least 15 letters)
- Amblyopia associated with strabismus, anisometropia, or both
- No more than 2 weeks of prior dichoptic treatment
- No cycloplegic eyedrops in the past 2 weeks
- Refractive correction required for specific levels of hypermetropia, myopia, astigmatism, or anisometropia
- Willingness to wear a headset and continue full-time spectacles or contact lenses if needed
- Interpupillary distance between 52mm and 72mm inclusive
- Investigator willing to prescribe necessary optical correction or dichoptic device
- Willing to accept random assignment to treatment groups for 19 weeks
- Parent understands the study and agrees to randomization
- Parent has phone access and agrees to contact
- No planned relocation outside study area within 36 weeks
You will not qualify if you...
- Heterotropia greater than 5 prism diopters at distance or near
- Prism correction greater than 8 diopters horizontal or 1 diopter vertical
- Current use of bifocal spectacles (unless discontinued 2 weeks prior)
- Myopia worse than -6.00 diopters spherical equivalent in either eye
- Eye conditions that may reduce visual acuity (except nystagmus if criteria met)
- Diplopia occurring more than once per week in the last week
- History of light-induced seizures
- Known simulator sickness
- Severe developmental delay interfering with treatment or evaluation
- 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 - 19 weeks
Participants receive dichoptic treatment using virtual reality headsets or continue optical correction as prescribed.
Weekly visits for monitoring and assessments
Trial Site Locations
Total: 58 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
University Eye Center at Ketchum Health
Anaheim, California, United States, 92807
Actively Recruiting
8
Univ. of California- Berkeley
Berkeley, California, United States, 94720
Actively Recruiting
9
Univ of California, Irvine- Gavin Herbert Eye Institute
Irvine, California, United States, 92697
Actively Recruiting
10
Stanford University
Palo Alto, California, United States, 94303
Actively Recruiting
11
Western University College of Optometry
Pomona, California, United States, 91766
Actively Recruiting
12
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
13
University of California San Francisco Department of Ophthalmology
San Francisco, California, United States, 94143
Actively Recruiting
14
Nova Southeastern University College of Optometry, The Eye Institute
Fort Lauderdale, Florida, United States, 33382
Actively Recruiting
15
University of South Florida (USF) Eye
Tampa, Florida, United States, 33620
Actively Recruiting
16
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
17
Illinois College of Optometry
Chicago, Illinois, United States, 60616
Actively Recruiting
18
Midwestern University Eye Institute
Downers Grove, Illinois, United States, 60515
Actively Recruiting
19
Progressive Eye Care
Lisle, Illinois, United States, 60532
Actively Recruiting
20
Indiana School of Optometry
Bloomington, Indiana, United States, 47405
Actively Recruiting
21
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
22
University of Kansas Dept of Ophthalmology
Prairie Village, Kansas, United States, 66208
Actively Recruiting
23
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204-5809
Actively Recruiting
24
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287-9028
Actively Recruiting
25
New England College of Optometry
Boston, Massachusetts, United States, 02115
Actively Recruiting
26
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
27
Boston Children's Hospital Waltham
Boston, Massachusetts, United States, 02453
Actively Recruiting
28
Michigan College of Optometry at Ferris State Univ
Big Rapids, Michigan, United States, 49307
Actively Recruiting
29
Pediatric Ophthalmology, P.C.
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
30
Zenith Vision Development Center
Duluth, Minnesota, United States, 55811
Actively Recruiting
31
University of Minnesota-Minnesota Lions Children's Eye Clinic
Minneapolis, Minnesota, United States, 55454
Actively Recruiting
32
Mayo Clinic Department of Ophthalmology
Rochester, Minnesota, United States, 55905
Actively Recruiting
33
PineCone Vision Center
Sartell, Minnesota, United States, 56377
Actively Recruiting
34
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
35
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68114
Actively Recruiting
36
NYU Langone Health
New York, New York, United States, 10017
Actively Recruiting
37
State University of New York, College of Optometry
New York, New York, United States, 10036
Actively Recruiting
38
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
39
Duke University Eye Center
Durham, North Carolina, United States, 27710
Actively Recruiting
40
University of North Dakota
Grand Forks, North Dakota, United States, 58202
Actively Recruiting
41
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
42
Cole Eye Institute
Cleveland, Ohio, United States, 44195
Actively Recruiting
43
Ohio State University College of Optometry
Columbus, Ohio, United States, 43210-1280
Actively Recruiting
44
Rainbow Babies and Children's Hospital Dept of Ophth
Mayfield Heights, Ohio, United States, 44124
Actively Recruiting
45
River View Family Eyecare
Albany, Oregon, United States, 97321
Actively Recruiting
46
OHSU Casey Eye Institute
Portland, Oregon, United States, 97239
Actively Recruiting
47
Pediatric Ophthalmology of Erie
Erie, Pennsylvania, United States, 16501
Actively Recruiting
48
Conestoga Eye
Lancaster, Pennsylvania, United States, 17601
Actively Recruiting
49
Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
50
Salus University/Pennsylvania College of Optometry
Philadelphia, Pennsylvania, United States, 19141
Actively Recruiting
51
Storm Eye Institute
Mt. Pleasant, South Carolina, United States, 29464
Actively Recruiting
52
Southern College of Optometry
Memphis, Tennessee, United States, 38104
Actively Recruiting
53
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
54
University of Houston - College of Optometry
Houston, Texas, United States, 77204
Actively Recruiting
55
University of Houston College of Optometry
Houston, Texas, United States, 77204
Actively Recruiting
56
San Antonio Eye Center
San Antonio, Texas, United States, 78215
Actively Recruiting
57
Virginia Pediatric Eye Center
Norfolk, Virginia, United States, 23502
Actively Recruiting
58
Spokane Eye Clinical Research
Spokane, Washington, United States, 99204
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
3
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