A Randomized Trial to Evaluate Sequential vs Simultaneous Patching
Purpose
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.
Condition
- Amblyopia
Eligibility
- Eligible Ages
- Between 3 Years and 13 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Age 3 to <13 years at the time of randomization 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
- Myopia greater than -6.00 D spherical equivalent in either eye. 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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator 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) |
|
|
Experimental Simultaneous treatment |
full-time spectacle correction and part-time patching for 2 hours per day/7 days per week |
|
Recruiting Locations
UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama 35294
Birmingham, Alabama 35294
University of Alabama at Birmingham
Birmingham, Alabama 35294
Birmingham, Alabama 35294
Midwestern University Eye Institute
Glendale, Arizona 85308
Glendale, Arizona 85308
Arizonia Pediatric Eye Specialists
Phoenix, Arizona 85006
Phoenix, Arizona 85006
University of Arizona
Tucson, Arizona 85711
Tucson, Arizona 85711
Univ. of California- Berkeley
Berkeley, California 94720
Berkeley, California 94720
Marshall B. Ketchum University
Fullerton, California 92831
Fullerton, California 92831
Univ of California, Irvine- Gavin Herbert Eye Institute
Irvine, California 92697
Irvine, California 92697
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda, California 92354
Loma Linda, California 92354
Children's Hospital of Los Angeles (CHLA)
Los Angeles, California 90027
Los Angeles, California 90027
Stanford University
Palo Alto, California 94303
Palo Alto, California 94303
Western University College of Optometry
Pomona, California 91766
Pomona, California 91766
University of California, Davis
Sacramento, California 95817
Sacramento, California 95817
University of California San Francisco Department of Ophthalmology
San Francisco, California 94143
San Francisco, California 94143
Eye Physicians & Surgeons, PC
Milford, Connecticut 06460
Milford, Connecticut 06460
Nova Southeastern University College of Optometry, The Eye Institute
Fort Lauderdale, Florida 33382
Fort Lauderdale, Florida 33382
Nemours Children's Clinic
Jacksonville, Florida 32207
Jacksonville, Florida 32207
Ticho Eye Associates
Chicago Ridge, Illinois 60415
Chicago Ridge, Illinois 60415
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois 60611
Chicago, Illinois 60611
Midwestern U Chicago College of Optometry
Downers Grove, Illinois 60515
Downers Grove, Illinois 60515
Progressive Eye Care
Lisle, Illinois 60532
Lisle, Illinois 60532
Indiana School of Optometry
Bloomington, Indiana 47405
Bloomington, Indiana 47405
Indiana University School of Optometry
Indianapolis, Indiana 47405
Indianapolis, Indiana 47405
Wolfe Eye Clinic
West Des Moines, Iowa 50266
West Des Moines, Iowa 50266
Wilmer Eye Institute
Baltimore, Maryland 21287-9028
Baltimore, Maryland 21287-9028
Boston Medical Center
Boston, Massachusetts 02118
Boston, Massachusetts 02118
Boston Children's Hospital Waltham
Boston, Massachusetts 02453
Boston, Massachusetts 02453
Helen DeVos Children's Hospital Pediatric Ophthalmology
Grand Rapids, Michigan 49503
Grand Rapids, Michigan 49503
Pediatric Ophthalmology, P.C.
Grand Rapids, Michigan 49546
Grand Rapids, Michigan 49546
PineCone Vision Center
Sartell, Minnesota 56377
Sartell, Minnesota 56377
Children's Mercy Hospitals and Clinics
Kansas City, Missouri 64108
Kansas City, Missouri 64108
St. Louis Children's Hospital Eye Center
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
U of MO St. Louis College of Optometry
Saint Louis, Missouri 63121
Saint Louis, Missouri 63121
University of Nebraska Medical Center
Omaha, Nebraska 68114
Omaha, Nebraska 68114
Ross Eye Institute, University of Buffalo, Med School Dept Ophthalmology
Buffalo, New York 14209
Buffalo, New York 14209
State University of New York, College of Optometry
New York, New York 10036
New York, New York 10036
University of North Carolina
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
Duke University Eye Center
Durham, North Carolina 27710
Durham, North Carolina 27710
Akron Children's Hospital
Akron, Ohio 44308
Akron, Ohio 44308
Cincinnati Children's Hospital
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
Ohio State University College of Optometry
Columbus, Ohio 43210-1280
Columbus, Ohio 43210-1280
River View Family Eyecare
Albany, Oregon 97321
Albany, Oregon 97321
Casey Eye Institute
Portland, Oregon 97239
Portland, Oregon 97239
Pediatric Ophthalmology of Erie
Erie, Pennsylvania 16501
Erie, Pennsylvania 16501
Conestoga Eye
Lancaster, Pennsylvania 17601
Lancaster, Pennsylvania 17601
Wills Eye Hospital
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
Salus University/Pennsylvania College of Optometry
Philadelphia, Pennsylvania 19141
Philadelphia, Pennsylvania 19141
Southern College of Optometry
Memphis, Tennessee 38104
Memphis, Tennessee 38104
Vanderbilt University Medical Center - Vanderbilt Eye Institute
Nashville, Tennessee 37232
Nashville, Tennessee 37232
Pediatric Eye Specialists, LLP
Fort Worth, Texas 76014
Fort Worth, Texas 76014
Contact:
Michael G Hunt, MD
Michael G Hunt, MD
Baylor College of Medicine
Houston, Texas 77030
Houston, Texas 77030
Contact:
Irene T Tung, MD
832-822-3230
Irene T Tung, MD
832-822-3230
Texas Tech University Health Science Center
Lubbock, Texas 79430
Lubbock, Texas 79430
University of the Incarnate Word
San Antonio, Texas 78209
San Antonio, Texas 78209
San Antonio Eye Center
San Antonio, Texas 78215
San Antonio, Texas 78215
University of Incarnate Word Rosenberg School of Optometry
San Antonio, Texas 78229
San Antonio, Texas 78229
Rocky Mountain Eye Care Associates
Salt Lake City, Utah 84107
Salt Lake City, Utah 84107
Virginia Pediatric Eye Center
Norfolk, Virginia 23502
Norfolk, Virginia 23502
Seattle Children's Hospital, University of Washington
Seattle, Washington 98105
Seattle, Washington 98105
Spokane Eye Clinical Research
Spokane, Washington 99204
Spokane, Washington 99204
Snowy Range Vision Center
Laramie, Wyoming 82070
Laramie, Wyoming 82070
More Details
- NCT ID
- NCT04378790
- Status
- Recruiting
- Sponsor
- Jaeb Center for Health Research
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.