A Randomized Trial to Evaluate Sequential vs Simultaneous Patching
ATS22
2 other identifiers
interventional
544
1 country
68
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2020
Longer than P75 for phase_3
68 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2020
CompletedFirst Posted
Study publicly available on registry
May 7, 2020
CompletedStudy Start
First participant enrolled
December 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
February 11, 2026
February 1, 2026
7.4 years
May 5, 2020
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Change in Amblyopic Eye logMAR distance Visual Acuity
1. Amblyopic eye VA (calculated as mean of test and retest) at the last visit that was the basis for a "stable resolved" or "stable residual" determination (in the sequential group, stable residual amblyopia criteria can be reached only after patching has been instituted); or 2. 56-week visit amblyopic-eye VA (calculated as mean of test and retest) in those completing a 56-week visit without ever meeting criteria for "stable resolved" or "stable residual" amblyopia (if retest missing at 56 weeks, the single test value will be used).
56 weeks
Secondary Outcomes (7)
Pediatric Eye Questionnaire (PedEyeQ)
56 weeks
Proportion Achieving Stable Resolved Outcome with Spectacles Alone
56 Weeks
Proportion of participants who achieve Binary distance visual acuity outcomes
56 weeks
Time to Stable Resolved Amblyopia
56 weeks
Difference in Mean Change of Distance Visual Acuity after 8 Weeks on Randomized Treatment
56 Weeks
- +2 more secondary outcomes
Study Arms (2)
Sequential treatment
ACTIVE COMPARATORfull-time spectacle correction first, with subsequent patching for 2 hours per day/7 days per week only if needed (no improvement (stable/worsening) and residual)
Simultaneous treatment
EXPERIMENTALfull-time spectacle correction and part-time patching for 2 hours per day/7 days per week
Interventions
Procedure in which the eye is covered utilizing a patch to increase the strength of the uncovered eye.
Eye Glasses are created and worn by patient to improve vision
Eligibility Criteria
You may qualify if:
- Age 3 to \<13 years at the time of randomization
- Amblyopia associated with anisometropia, strabismus, or both
- o Criteria for strabismic amblyopia: At least one of the following must be met:
- Presence of a heterotropia on examination at distance or near fixation (with or without optical correction)
- Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia)
- Criteria for anisometropia: At least one of the following criteria must be met:
- D difference between eyes in spherical equivalent (SE)
- D difference in astigmatism between corresponding meridians in the two eyes
- Criteria for combined-mechanism amblyopia: Both of the following criteria must be met:
- Criteria for strabismus are met (see above)
- D difference between eyes in spherical equivalent OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes
- No previous treatment for amblyopia, including no more than 24 hours of spectacle wear.
- Investigator planning to initiate spectacle correction of refractive error meeting the following criteria based on a cycloplegic refraction that has been performed within 30 days:
- Full correction of anisometropia
- Full correction of astigmatism with the same axis found by the cycloplegic refraction
- +14 more criteria
You may not qualify if:
- Myopia greater than -6.00 D spherical equivalent in either eye.
- Previous intraocular or refractive surgery.
- Planned strabismus surgery in the next 56 weeks.
- Any previous treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy, or binocular treatment).
- Previous spectacle or contact lens wear for more than 24 hours.
- Parent and participant willing to forego option of contact lens wear for the duration of the study.
- Ocular co-morbidity that may reduce VA determined by an ocular examination performed within the past 7 months (Note: nystagmus per se does not exclude the participant if the above VA criteria are met).
- Severe developmental delay that would interfere with treatment or evaluation (in the opinion of the investigator). Participants with mild speech delay or reading and/or learning disabilities or attention deficit hyperactivity disorder (ADHD) are not excluded.
- Known allergy to adhesive patches.
- Known allergy to silicone.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Eye Institute (NEI)collaborator
- Pediatric Eye Disease Investigator Groupcollaborator
- Jaeb Center for Health Researchlead
Study Sites (68)
UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama, 35294, United States
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Midwestern University Eye Institute
Glendale, Arizona, 85308, United States
Arizonia Pediatric Eye Specialists
Phoenix, Arizona, 85006, United States
University of Arizona
Tucson, Arizona, 85711, United States
Univ. of California- Berkeley
Berkeley, California, 94720, United States
Marshall B. Ketchum University
Fullerton, California, 92831, United States
Univ of California, Irvine- Gavin Herbert Eye Institute
Irvine, California, 92697, United States
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California, 92354, United States
Children's Hospital of Los Angeles (CHLA)
Los Angeles, California, 90027, United States
Stanford University
Palo Alto, California, 94303, United States
Western University College of Optometry
Pomona, California, 91766, United States
University of California, Davis
Sacramento, California, 95817, United States
University of California San Francisco Department of Ophthalmology
San Francisco, California, 94143, United States
Eye Physicians & Surgeons, PC
Milford, Connecticut, 06460, United States
Nova Southeastern University College of Optometry, The Eye Institute
Fort Lauderdale, Florida, 33382, United States
Nemours Children's Clinic
Jacksonville, Florida, 32207, United States
University of South Florida (USF) Eye
Tampa, Florida, 33620, United States
St Luke's Hospital
Boise, Idaho, 83702, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Ticho Eye Associates
Chicago Ridge, Illinois, 60415, United States
Midwestern U Chicago College of Optometry
Downers Grove, Illinois, 60515, United States
Progressive Eye Care
Lisle, Illinois, 60532, United States
Indiana School of Optometry
Bloomington, Indiana, 47405, United States
Indiana University School of Optometry
Indianapolis, Indiana, 47405, United States
Wolfe Eye Clinic
West Des Moines, Iowa, 50266, United States
Wilmer Eye Institute
Baltimore, Maryland, 21287-9028, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Boston Children's Hospital Waltham
Boston, Massachusetts, 02453, United States
Corewell Health
Grand Rapids, Michigan, 49503, United States
Pediatric Ophthalmology, P.C.
Grand Rapids, Michigan, 49546, United States
Zenith Vision Development Center
Duluth, Minnesota, 55811, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
PineCone Vision Center
Sartell, Minnesota, 56377, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108, United States
St. Louis Children's Hospital Eye Center
St Louis, Missouri, 63110, United States
U of MO St. Louis College of Optometry
St Louis, Missouri, 63121, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68114, United States
Ross Eye Institute, University of Buffalo, Med School Dept Ophthalmology
Buffalo, New York, 14209, United States
NYU Langone Health
New York, New York, 10017, United States
State University of New York, College of Optometry
New York, New York, 10036, United States
University of North Carolina
Chapel Hill, North Carolina, 27599, United States
Duke University Eye Center
Durham, North Carolina, 27710, United States
Akron Children's Hospital
Akron, Ohio, 44308, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229, United States
Ohio State University College of Optometry
Columbus, Ohio, 43210-1280, United States
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, 73104, United States
River View Family Eyecare
Albany, Oregon, 97321, United States
Casey Eye Institute
Portland, Oregon, 97239, United States
Pediatric Ophthalmology of Erie
Erie, Pennsylvania, 16501, United States
Conestoga Eye
Lancaster, Pennsylvania, 17601, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, 19107, United States
Salus University/Pennsylvania College of Optometry
Philadelphia, Pennsylvania, 19141, United States
UPMC Children's Eye Center of Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
Prisma Health
Columbia, South Carolina, 29203, United States
Southern College of Optometry
Memphis, Tennessee, 38104, United States
Vanderbilt University Medical Center - Vanderbilt Eye Institute
Nashville, Tennessee, 37232, United States
Pediatric Eye Specialists, LLP
Fort Worth, Texas, 76014, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
Texas Tech University Health Science Center
Lubbock, Texas, 79430, United States
University of the Incarnate Word
San Antonio, Texas, 78209, United States
San Antonio Eye Center
San Antonio, Texas, 78215, United States
University of Incarnate Word Rosenberg School of Optometry
San Antonio, Texas, 78229, United States
Rocky Mountain Eye Care Associates
Salt Lake City, Utah, 84107, United States
Virginia Pediatric Eye Center
Norfolk, Virginia, 23502, United States
Seattle Children's Hospital, University of Washington
Seattle, Washington, 98105, United States
Spokane Eye Clinical Research
Spokane, Washington, 99204, United States
Snowy Range Vision Center
Laramie, Wyoming, 82070, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Vivian Manh
Seattle Children's Hospital, University of Washington
- STUDY CHAIR
Michael Gray
Children's Hospital Medical Center, Cincinnati
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 5, 2020
First Posted
May 7, 2020
Study Start
December 8, 2020
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
February 11, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be made available after publication.
- Access Criteria
- Users accessing the data must enter an email address.
In accordance with the NIH data sharing policy, a de-identified database is placed in the public domain on the Pediatric Eye Disease Investigator Group (PEDIG) public website after the completion of each protocol and publication of the primary manuscript.