A Randomized Trial to Evaluate Sequential vs Simultaneous Patching
Start Date
12/8/2020
Completion Date
5/1/2028
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.
Detailed Description
At an enrollment visit, distance VA will be measured in trial frames with or without cycloplegia based on a cycloplegic refraction performed within 30 days. If still apparently eligible, children will be prescribed spectacles and will then return for a spectacle baseline visit, where they will wear their new spectacles for the first time for at least 10 minutes (but no more than 24 hours) and will be tested in those new spectacles to confirm final eligibility prior to randomization. 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.
Eligibility Criteria
Age Range: 3 years to 13 years
Interventions
Patching
Glasses
Conditions
Locations
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