Actively Recruiting
A Randomized Trial to Evaluate Sequential vs Simultaneous Spectacles Plus Patching for Amblyopia in Children 3 to <13 Years Old
Led by Jaeb Center for Health Research · Updated on 2026-02-11
544
Participants Needed
68
Research Sites
N/A
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
This research aims to compare two approaches for treating previously untreated amblyopia in children aged 3 to under 13 years. It evaluates whether using glasses and patching at the same time leads to similar improvements in vision as first using glasses alone, followed by patching only if needed. The trial focuses on children with amblyopia caused by differences in eye alignment or prescription errors. Children will be assigned randomly to one of two treatment groups: one group will wear glasses full-time and add patching for 2 hours daily only if there is no improvement after glasses alone; the other group will wear glasses and patch the weaker eye for 2 hours daily at the same time from the start. Vision tests will be done at baseline and follow-up visits every 8 weeks for up to 56 weeks. Participants will have their distance visual acuity measured with trial frames before and after getting their glasses to confirm eligibility. During the study, vision will be monitored to classify improvement or stability, guiding whether patching is needed in the sequential group. Outcomes include changes in vision clarity after 56 weeks and quality-of-life assessments. Regular visits help track progress and safety until study completion.
CONDITIONS
Brief Title
A Randomized Trial to Evaluate Sequential vs Simultaneous Patching
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 3 to <13 years at the time of randomization
- Amblyopia caused by anisometropia, strabismus, or both
- For strabismic amblyopia: presence or history of eye misalignment that may have caused amblyopia
- For anisometropia: at least 1.00 D difference in spherical equivalent or 1.50 D difference in astigmatism between eyes
- For combined amblyopia: criteria for strabismus plus anisometropia
- No previous amblyopia treatment, including no more than 24 hours of wearing glasses
- Investigator plans to prescribe full spectacle correction based on recent cycloplegic refraction
- Visual acuity in amblyopic eye between 20/40 and 20/200; age-normal vision in fellow eye
- Parent understands and agrees to study procedures and randomization
- Parent has phone access and agrees to study contact
- No plans to relocate outside study area during 56-week study period
You will not qualify if you...
- Myopia worse than -6.00 D spherical equivalent in either eye
- Previous eye surgery affecting vision
- Planned strabismus surgery within 56 weeks
- Any prior amblyopia treatment such as patching, atropine, vision therapy, or binocular treatment
- More than 24 hours of prior spectacle or contact lens wear
- Willingness to avoid contact lenses during the study
- Eye conditions that reduce vision other than amblyopia
- Severe developmental delays interfering with treatment or assessment
- Known allergy to adhesive patches or silicone materials
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) for enrollment and initial eligibility assessment
Duration - Up to 24 hours
Participants are prescribed spectacles and wear them for the first time to confirm final eligibility before randomization.
1 spectacle baseline visit (in-person)
Duration - 56 weeks
Participants receive either sequential treatment with spectacles alone initially and patching added if needed, or simultaneous treatment with spectacles and patching together.
Follow-up visits every 8 weeks during treatment
Duration - Up to 56 weeks concurrent with treatment
Participants continue follow-up visits every 8 weeks to monitor vision status and treatment response until study participation ends at 56 weeks.
Follow-up visits every 8 weeks
Trial Site Locations
Total: 68 locations
1
UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
3
Midwestern University Eye Institute
Glendale, Arizona, United States, 85308
Actively Recruiting
4
Arizonia Pediatric Eye Specialists
Phoenix, Arizona, United States, 85006
Actively Recruiting
5
University of Arizona
Tucson, Arizona, United States, 85711
Actively Recruiting
6
Univ. of California- Berkeley
Berkeley, California, United States, 94720
Actively Recruiting
7
Marshall B. Ketchum University
Fullerton, California, United States, 92831
Actively Recruiting
8
Univ of California, Irvine- Gavin Herbert Eye Institute
Irvine, California, United States, 92697
Actively Recruiting
9
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California, United States, 92354
Actively Recruiting
10
Children's Hospital of Los Angeles (CHLA)
Los Angeles, California, United States, 90027
Actively Recruiting
11
Stanford University
Palo Alto, California, United States, 94303
Actively Recruiting
12
Western University College of Optometry
Pomona, California, United States, 91766
Actively Recruiting
13
University of California, Davis
Sacramento, California, United States, 95817
Actively Recruiting
14
University of California San Francisco Department of Ophthalmology
San Francisco, California, United States, 94143
Actively Recruiting
15
Eye Physicians & Surgeons, PC
Milford, Connecticut, United States, 06460
Actively Recruiting
16
Nova Southeastern University College of Optometry, The Eye Institute
Fort Lauderdale, Florida, United States, 33382
Actively Recruiting
17
Nemours Children's Clinic
Jacksonville, Florida, United States, 32207
Actively Recruiting
18
University of South Florida (USF) Eye
Tampa, Florida, United States, 33620
Actively Recruiting
19
St Luke's Hospital
Boise, Idaho, United States, 83702
Actively Recruiting
20
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
21
Ticho Eye Associates
Chicago Ridge, Illinois, United States, 60415
Actively Recruiting
22
Midwestern U Chicago College of Optometry
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
Indiana University School of Optometry
Indianapolis, Indiana, United States, 47405
Actively Recruiting
26
Wolfe Eye Clinic
West Des Moines, Iowa, United States, 50266
Actively Recruiting
27
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287-9028
Actively Recruiting
28
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
29
Boston Children's Hospital Waltham
Boston, Massachusetts, United States, 02453
Actively Recruiting
30
Corewell Health
Grand Rapids, Michigan, United States, 49503
Actively Recruiting
31
Pediatric Ophthalmology, P.C.
Grand Rapids, Michigan, United States, 49546
Actively Recruiting
32
Zenith Vision Development Center
Duluth, Minnesota, United States, 55811
Actively Recruiting
33
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
34
PineCone Vision Center
Sartell, Minnesota, United States, 56377
Actively Recruiting
35
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
Actively Recruiting
36
St. Louis Children's Hospital Eye Center
St Louis, Missouri, United States, 63110
Actively Recruiting
37
U of MO St. Louis College of Optometry
St Louis, Missouri, United States, 63121
Actively Recruiting
38
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68114
Actively Recruiting
39
Ross Eye Institute, University of Buffalo, Med School Dept Ophthalmology
Buffalo, New York, United States, 14209
Actively Recruiting
40
NYU Langone Health
New York, New York, United States, 10017
Actively Recruiting
41
State University of New York, College of Optometry
New York, New York, United States, 10036
Actively Recruiting
42
University of North Carolina
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
43
Duke University Eye Center
Durham, North Carolina, United States, 27710
Actively Recruiting
44
Akron Children's Hospital
Akron, Ohio, United States, 44308
Actively Recruiting
45
Cincinnati Children's Hospital
Cincinnati, Ohio, United States, 45229
Actively Recruiting
46
Ohio State University College of Optometry
Columbus, Ohio, United States, 43210-1280
Actively Recruiting
47
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States, 73104
Actively Recruiting
48
River View Family Eyecare
Albany, Oregon, United States, 97321
Actively Recruiting
49
Casey Eye Institute
Portland, Oregon, United States, 97239
Actively Recruiting
50
Pediatric Ophthalmology of Erie
Erie, Pennsylvania, United States, 16501
Actively Recruiting
51
Conestoga Eye
Lancaster, Pennsylvania, United States, 17601
Actively Recruiting
52
Wills Eye Hospital
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
53
Salus University/Pennsylvania College of Optometry
Philadelphia, Pennsylvania, United States, 19141
Actively Recruiting
54
UPMC Children's Eye Center of Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
55
Prisma Health
Columbia, South Carolina, United States, 29203
Actively Recruiting
56
Southern College of Optometry
Memphis, Tennessee, United States, 38104
Actively Recruiting
57
Vanderbilt University Medical Center - Vanderbilt Eye Institute
Nashville, Tennessee, United States, 37232
Actively Recruiting
58
Pediatric Eye Specialists, LLP
Fort Worth, Texas, United States, 76014
Actively Recruiting
59
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
60
Texas Tech University Health Science Center
Lubbock, Texas, United States, 79430
Actively Recruiting
61
University of the Incarnate Word
San Antonio, Texas, United States, 78209
Actively Recruiting
62
San Antonio Eye Center
San Antonio, Texas, United States, 78215
Actively Recruiting
63
University of Incarnate Word Rosenberg School of Optometry
San Antonio, Texas, United States, 78229
Actively Recruiting
64
Rocky Mountain Eye Care Associates
Salt Lake City, Utah, United States, 84107
Actively Recruiting
65
Virginia Pediatric Eye Center
Norfolk, Virginia, United States, 23502
Actively Recruiting
66
Seattle Children's Hospital, University of Washington
Seattle, Washington, United States, 98105
Actively Recruiting
67
Spokane Eye Clinical Research
Spokane, Washington, United States, 99204
Actively Recruiting
68
Snowy Range Vision Center
Laramie, Wyoming, United States, 82070
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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