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 Sex
- 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 4049979, Alabama 4829764 35294
Birmingham 4049979, Alabama 4829764 35294
University of Alabama at Birmingham
Birmingham 4049979, Alabama 4829764 35294
Birmingham 4049979, Alabama 4829764 35294
Midwestern University Eye Institute
Glendale 5295985, Arizona 5551752 85308
Glendale 5295985, Arizona 5551752 85308
Arizonia Pediatric Eye Specialists
Phoenix 5308655, Arizona 5551752 85006
Phoenix 5308655, Arizona 5551752 85006
University of Arizona
Tucson 5318313, Arizona 5551752 85711
Tucson 5318313, Arizona 5551752 85711
Univ. of California- Berkeley
Berkeley 5327684, California 5332921 94720
Berkeley 5327684, California 5332921 94720
Marshall B. Ketchum University
Fullerton 5351247, California 5332921 92831
Fullerton 5351247, California 5332921 92831
Univ of California, Irvine- Gavin Herbert Eye Institute
Irvine 5359777, California 5332921 92697
Irvine 5359777, California 5332921 92697
Loma Linda University Health Care, Dept. of Ophthalmology
Loma Linda 5367696, California 5332921 92354
Loma Linda 5367696, California 5332921 92354
Children's Hospital of Los Angeles (CHLA)
Los Angeles 5368361, California 5332921 90027
Los Angeles 5368361, California 5332921 90027
Stanford University
Palo Alto 5380748, California 5332921 94303
Palo Alto 5380748, California 5332921 94303
Western University College of Optometry
Pomona 5384170, California 5332921 91766
Pomona 5384170, California 5332921 91766
University of California, Davis
Sacramento 5389489, California 5332921 95817
Sacramento 5389489, California 5332921 95817
University of California San Francisco Department of Ophthalmology
San Francisco 5391959, California 5332921 94143
San Francisco 5391959, California 5332921 94143
Eye Physicians & Surgeons, PC
Milford 4838652, Connecticut 4831725 06460
Milford 4838652, Connecticut 4831725 06460
Nova Southeastern University College of Optometry, The Eye Institute
Fort Lauderdale 4155966, Florida 4155751 33382
Fort Lauderdale 4155966, Florida 4155751 33382
Nemours Children's Clinic
Jacksonville 4160021, Florida 4155751 32207
Jacksonville 4160021, Florida 4155751 32207
University of South Florida (USF) Eye
Tampa 4174757, Florida 4155751 33620
Tampa 4174757, Florida 4155751 33620
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago 4887398, Illinois 4896861 60611
Chicago 4887398, Illinois 4896861 60611
Ticho Eye Associates
Chicago Ridge 4887492, Illinois 4896861 60415
Chicago Ridge 4887492, Illinois 4896861 60415
Midwestern U Chicago College of Optometry
Downers Grove 4890119, Illinois 4896861 60515
Downers Grove 4890119, Illinois 4896861 60515
Progressive Eye Care
Lisle 4900080, Illinois 4896861 60532
Lisle 4900080, Illinois 4896861 60532
Indiana School of Optometry
Bloomington 4254679, Indiana 4921868 47405
Bloomington 4254679, Indiana 4921868 47405
Indiana University School of Optometry
Indianapolis 4259418, Indiana 4921868 47405
Indianapolis 4259418, Indiana 4921868 47405
Wolfe Eye Clinic
West Des Moines 4881346, Iowa 4862182 50266
West Des Moines 4881346, Iowa 4862182 50266
Wilmer Eye Institute
Baltimore 4347778, Maryland 4361885 21287-9028
Baltimore 4347778, Maryland 4361885 21287-9028
Boston Medical Center
Boston 4930956, Massachusetts 6254926 02118
Boston 4930956, Massachusetts 6254926 02118
Boston Children's Hospital Waltham
Boston 4930956, Massachusetts 6254926 02453
Boston 4930956, Massachusetts 6254926 02453
Corewell Health
Grand Rapids 4994358, Michigan 5001836 49503
Grand Rapids 4994358, Michigan 5001836 49503
Pediatric Ophthalmology, P.C.
Grand Rapids 4994358, Michigan 5001836 49546
Grand Rapids 4994358, Michigan 5001836 49546
Zenith Vision Development Center
Duluth 5024719, Minnesota 5037779 55811
Duluth 5024719, Minnesota 5037779 55811
Mayo Clinic
Rochester 5043473, Minnesota 5037779 55905
Rochester 5043473, Minnesota 5037779 55905
PineCone Vision Center
Sartell 5046001, Minnesota 5037779 56377
Sartell 5046001, Minnesota 5037779 56377
Children's Mercy Hospitals and Clinics
Kansas City 4393217, Missouri 4398678 64108
Kansas City 4393217, Missouri 4398678 64108
St. Louis Children's Hospital Eye Center
St Louis 4407066, Missouri 4398678 63110
St Louis 4407066, Missouri 4398678 63110
U of MO St. Louis College of Optometry
St Louis 4407066, Missouri 4398678 63121
St Louis 4407066, Missouri 4398678 63121
University of Nebraska Medical Center
Omaha 5074472, Nebraska 5073708 68114
Omaha 5074472, Nebraska 5073708 68114
Ross Eye Institute, University of Buffalo, Med School Dept Ophthalmology
Buffalo 5110629, New York 5128638 14209
Buffalo 5110629, New York 5128638 14209
NYU Langone Health
New York 5128581, New York 5128638 10017
New York 5128581, New York 5128638 10017
State University of New York, College of Optometry
New York 5128581, New York 5128638 10036
New York 5128581, New York 5128638 10036
University of North Carolina
Chapel Hill 4460162, North Carolina 4482348 27599
Chapel Hill 4460162, North Carolina 4482348 27599
Duke University Eye Center
Durham 4464368, North Carolina 4482348 27710
Durham 4464368, North Carolina 4482348 27710
Akron Children's Hospital
Akron 5145476, Ohio 5165418 44308
Akron 5145476, Ohio 5165418 44308
Cincinnati Children's Hospital
Cincinnati 4508722, Ohio 5165418 45229
Cincinnati 4508722, Ohio 5165418 45229
Ohio State University College of Optometry
Columbus 4509177, Ohio 5165418 43210-1280
Columbus 4509177, Ohio 5165418 43210-1280
Dean A. McGee Eye Institute
Oklahoma City 4544349, Oklahoma 4544379 73104
Oklahoma City 4544349, Oklahoma 4544379 73104
River View Family Eyecare
Albany 5710756, Oregon 5744337 97321
Albany 5710756, Oregon 5744337 97321
Casey Eye Institute
Portland 5746545, Oregon 5744337 97239
Portland 5746545, Oregon 5744337 97239
Pediatric Ophthalmology of Erie
Erie 5188843, Pennsylvania 6254927 16501
Erie 5188843, Pennsylvania 6254927 16501
Conestoga Eye
Lancaster 5197079, Pennsylvania 6254927 17601
Lancaster 5197079, Pennsylvania 6254927 17601
Wills Eye Hospital
Philadelphia 4560349, Pennsylvania 6254927 19107
Philadelphia 4560349, Pennsylvania 6254927 19107
Salus University/Pennsylvania College of Optometry
Philadelphia 4560349, Pennsylvania 6254927 19141
Philadelphia 4560349, Pennsylvania 6254927 19141
UPMC Children's Eye Center of Children's Hospital of Pittsburgh
Pittsburgh 5206379, Pennsylvania 6254927 15224
Pittsburgh 5206379, Pennsylvania 6254927 15224
Prisma Health
Columbia 4575352, South Carolina 4597040 29203
Columbia 4575352, South Carolina 4597040 29203
Southern College of Optometry
Memphis 4641239, Tennessee 4662168 38104
Memphis 4641239, Tennessee 4662168 38104
Vanderbilt University Medical Center - Vanderbilt Eye Institute
Nashville 4644585, Tennessee 4662168 37232
Nashville 4644585, Tennessee 4662168 37232
Pediatric Eye Specialists, LLP
Fort Worth 4691930, Texas 4736286 76014
Fort Worth 4691930, Texas 4736286 76014
Contact:
Michael G Hunt, MD
Michael G Hunt, MD
Baylor College of Medicine
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 77030
Contact:
Irene T Tung, MD
832-822-3230
Irene T Tung, MD
832-822-3230
Texas Tech University Health Science Center
Lubbock 5525577, Texas 4736286 79430
Lubbock 5525577, Texas 4736286 79430
University of the Incarnate Word
San Antonio 4726206, Texas 4736286 78209
San Antonio 4726206, Texas 4736286 78209
San Antonio Eye Center
San Antonio 4726206, Texas 4736286 78215
San Antonio 4726206, Texas 4736286 78215
University of Incarnate Word Rosenberg School of Optometry
San Antonio 4726206, Texas 4736286 78229
San Antonio 4726206, Texas 4736286 78229
Rocky Mountain Eye Care Associates
Salt Lake City 5780993, Utah 5549030 84107
Salt Lake City 5780993, Utah 5549030 84107
Virginia Pediatric Eye Center
Norfolk 4776222, Virginia 6254928 23502
Norfolk 4776222, Virginia 6254928 23502
Seattle Children's Hospital, University of Washington
Seattle 5809844, Washington 5815135 98105
Seattle 5809844, Washington 5815135 98105
Spokane Eye Clinical Research
Spokane 5811696, Washington 5815135 99204
Spokane 5811696, Washington 5815135 99204
Snowy Range Vision Center
Laramie 5830062, Wyoming 5843591 82070
Laramie 5830062, Wyoming 5843591 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.