A Randomized Trial to Evaluate Sequential vs Simultaneous Patching
NCT ID: NCT04378790
Last Updated: 2026-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
544 participants
INTERVENTIONAL
2020-12-08
2028-05-01
Brief Summary
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Detailed Description
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Participants not found to be eligible in their new spectacles will end study participation. Participants eligible for the study will be randomly allocated to one of two treatment groups: Sequential (spectacles alone) and then patching if needed (monitored by ODM), or Simultaneous (spectacles and patching monitored by ODM).
After randomization, follow-up visits will occur at 8-week intervals through 56 weeks. At each visit on or after the 8-week visit, participants will be classified as either: stable/worsening or improving; those stable/worsening are then classified as having either resolved or residual amblyopia, provided that the current and most recent previous visit were completed at least 6-weeks apart (target 8 weeks) and provided the required test and retest VA testing was completed. Participants who are stable/worsening and have residual amblyopia in the sequential group will start patching (monitored by ODM) and continue to be followed every 8 weeks. Participants in the simultaneous group, or in the sequential group after having advanced to patching, who are stable/worsening but have residual amblyopia will be released to treatment at investigator discretion.
All participants continue 8-weekly visits until 56 weeks when Study participation ends.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Sequential treatment
full-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)
Patching
Procedure in which the eye is covered utilizing a patch to increase the strength of the uncovered eye.
Glasses
Eye Glasses are created and worn by patient to improve vision
Simultaneous treatment
full-time spectacle correction and part-time patching for 2 hours per day/7 days per week
Patching
Procedure in which the eye is covered utilizing a patch to increase the strength of the uncovered eye.
Glasses
Eye Glasses are created and worn by patient to improve vision
Interventions
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Patching
Procedure in which the eye is covered utilizing a patch to increase the strength of the uncovered eye.
Glasses
Eye Glasses are created and worn by patient to improve vision
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. 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:
* 1.00 D difference between eyes in spherical equivalent (SE)
* 1.50 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)
* 1.00 D difference between eyes in spherical equivalent OR ≥1.50 D difference in astigmatism between corresponding meridians in the two eyes
3. No previous treatment for amblyopia, including no more than 24 hours of spectacle wear.
4. 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:
1. Full correction of anisometropia
2. Full correction of astigmatism with the same axis found by the cycloplegic refraction
3. Full correction of any myopia
4. Hyperopia must not be under corrected by more than 1.50 D, and reduction in plus sphere must be symmetric in the two eyes.
5. At enrollment, single VA measured in each eye assessed in trial frames with the spectacle correction the investigator plans to prescribe, using the investigator's routine method as follows:
* VA in the amblyopic eye 20/40 to 20/200 inclusive.
* Age-normal VA in the fellow eye:40,41
* 3 years: 0.4 logMAR (20/50) or better
* 4 years: 0.3 logMAR (20/40) or better
* 5-6 years: 0.2 logMAR (20/32) or better
* 7-12 years: 0.12 logMAR (78 letters) or better
* Interocular difference ≥ 3 logMAR lines (0.3 logMAR) or ≥ 15 letters o When participants return for the Spectacle Baseline / Randomization Visit with their new spectacles, they will need to meet the same criteria as above using the ATS-HOTV or E-ETDRS protocol after wearing the new spectacles for at least 10 minutes (based upon the mean of a test and retest of VA in those new spectacles).
6. Investigator is willing to prescribe spectacle wear followed sequentially by patching or simultaneous spectacles and patching treatment per protocol.
7. Parent understands the protocol and is willing to accept randomization.
8. Parent has phone (or access to phone) and is willing to be contacted by Jaeb Center staff or other study staff.
9. Relocation outside of area of an active PEDIG site for this study within the next 56 weeks is not anticipated.
Exclusion Criteria
2. Previous intraocular or refractive surgery.
3. Planned strabismus surgery in the next 56 weeks.
4. Any previous treatment for amblyopia (patching, atropine, Bangerter filter, vision therapy, or binocular treatment).
5. Previous spectacle or contact lens wear for more than 24 hours.
6. Parent and participant willing to forego option of contact lens wear for the duration of the study.
7. 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).
8. 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.
9. Known allergy to adhesive patches.
10. Known allergy to silicone.
3 Years
13 Years
ALL
No
Sponsors
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National Eye Institute (NEI)
NIH
Pediatric Eye Disease Investigator Group
NETWORK
Jaeb Center for Health Research
OTHER
Responsible Party
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Principal Investigators
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Vivian Manh
Role: STUDY_CHAIR
Seattle Children's Hospital, University of Washington
Michael Gray
Role: STUDY_CHAIR
Children's Hospital Medical Center, Cincinnati
Locations
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UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama, United States
University of Alabama at Birmingham
Birmingham, Alabama, United States
Midwestern University Eye Institute
Glendale, Arizona, United States
Arizonia Pediatric Eye Specialists
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
Univ. of California- Berkeley
Berkeley, California, United States
Marshall B. Ketchum University
Fullerton, California, United States
Univ of California, Irvine- Gavin Herbert Eye Institute
Irvine, California, United States
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California, United States
Children's Hospital of Los Angeles (CHLA)
Los Angeles, California, United States
Stanford University
Palo Alto, California, United States
Western University College of Optometry
Pomona, California, United States
University of California, Davis
Sacramento, California, United States
University of California San Francisco Department of Ophthalmology
San Francisco, California, United States
Eye Physicians & Surgeons, PC
Milford, Connecticut, United States
Nova Southeastern University College of Optometry, The Eye Institute
Fort Lauderdale, Florida, United States
Nemours Children's Clinic
Jacksonville, Florida, United States
University of South Florida (USF) Eye
Tampa, Florida, United States
St Luke's Hospital
Boise, Idaho, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
Ticho Eye Associates
Chicago Ridge, Illinois, United States
Midwestern U Chicago College of Optometry
Downers Grove, Illinois, United States
Progressive Eye Care
Lisle, Illinois, United States
Indiana School of Optometry
Bloomington, Indiana, United States
Indiana University School of Optometry
Indianapolis, Indiana, United States
Wolfe Eye Clinic
West Des Moines, Iowa, United States
Wilmer Eye Institute
Baltimore, Maryland, United States
Boston Medical Center
Boston, Massachusetts, United States
Boston Children's Hospital Waltham
Boston, Massachusetts, United States
Corewell Health
Grand Rapids, Michigan, United States
Pediatric Ophthalmology, P.C.
Grand Rapids, Michigan, United States
Zenith Vision Development Center
Duluth, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
PineCone Vision Center
Sartell, Minnesota, United States
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States
St. Louis Children's Hospital Eye Center
St Louis, Missouri, United States
U of MO St. Louis College of Optometry
St Louis, Missouri, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Ross Eye Institute, University of Buffalo, Med School Dept Ophthalmology
Buffalo, New York, United States
NYU Langone Health
New York, New York, United States
State University of New York, College of Optometry
New York, New York, United States
University of North Carolina
Chapel Hill, North Carolina, United States
Duke University Eye Center
Durham, North Carolina, United States
Akron Children's Hospital
Akron, Ohio, United States
Cincinnati Children's Hospital
Cincinnati, Ohio, United States
Ohio State University College of Optometry
Columbus, Ohio, United States
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, United States
River View Family Eyecare
Albany, Oregon, United States
Casey Eye Institute
Portland, Oregon, United States
Pediatric Ophthalmology of Erie
Erie, Pennsylvania, United States
Conestoga Eye
Lancaster, Pennsylvania, United States
Wills Eye Hospital
Philadelphia, Pennsylvania, United States
Salus University/Pennsylvania College of Optometry
Philadelphia, Pennsylvania, United States
UPMC Children's Eye Center of Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States
Prisma Health
Columbia, South Carolina, United States
Southern College of Optometry
Memphis, Tennessee, United States
Vanderbilt University Medical Center - Vanderbilt Eye Institute
Nashville, Tennessee, United States
Pediatric Eye Specialists, LLP
Fort Worth, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Texas Tech University Health Science Center
Lubbock, Texas, United States
University of the Incarnate Word
San Antonio, Texas, United States
San Antonio Eye Center
San Antonio, Texas, United States
University of Incarnate Word Rosenberg School of Optometry
San Antonio, Texas, United States
Rocky Mountain Eye Care Associates
Salt Lake City, Utah, United States
Virginia Pediatric Eye Center
Norfolk, Virginia, United States
Seattle Children's Hospital, University of Washington
Seattle, Washington, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
Snowy Range Vision Center
Laramie, Wyoming, United States
Countries
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Central Contacts
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Brooke P Fimbel
Role: CONTACT
Facility Contacts
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Michael G Hunt, MD
Role: primary
Irene T Tung, MD
Role: primary
Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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ATS22
Identifier Type: -
Identifier Source: org_study_id
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