Actively Recruiting
A Randomized Trial to Evaluate Sequential vs Simultaneous Patching
Led by Jaeb Center for Health Research · Updated on 2026-02-11
544
Participants Needed
68
Research Sites
385 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
A randomized trial to determine whether simultaneous treatment with spectacles and patching has an equivalent VA outcome compared with sequential treatment, first with spectacles alone followed by patching (if needed), for previously untreated amblyopia in children 3 to \<13 years of age.
CONDITIONS
Official Title
A Randomized Trial to Evaluate Sequential vs Simultaneous Patching
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 3 to under 13 years at randomization
- Amblyopia due to anisometropia, strabismus, or both
- For strabismic amblyopia: presence of eye misalignment or past history possibly causing amblyopia
- For anisometropia: 1.00 D difference in spherical equivalent or 1.50 D difference in astigmatism between eyes
- For combined amblyopia: criteria for strabismus plus anisometropia criteria
- No prior amblyopia treatment except no more than 24 hours of spectacle wear
- Investigator plans to start full spectacle correction based on recent cycloplegic refraction
- Visual acuity in amblyopic eye between 20/40 and 20/200 at enrollment
- Age-normal vision in the fellow eye
- Interocular visual acuity difference of at least 3 logMAR lines or 15 letters
- Parent willing to accept randomization and understands the protocol
- Parent has phone access and agrees to contact
- No expected relocation outside study area during 56 weeks
You will not qualify if you...
- Myopia worse than -6.00 diopters in either eye
- Previous intraocular or refractive surgery
- Planned strabismus surgery within 56 weeks
- Any previous amblyopia treatment including patching, atropine, filters, vision therapy, or binocular treatment
- More than 24 hours of previous spectacle or contact lens wear
- Willingness to avoid contact lens wear during study
- Eye conditions that may reduce vision other than amblyopia
- Severe developmental delay interfering with treatment or evaluation
- Known allergy to adhesive patches or silicone
- Nystagmus is allowed if vision criteria are met
- Mild speech delay, learning disabilities, or ADHD are not excluded
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
B
Brooke P Fimbel
CONTACT
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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