RECRUITING

A Randomized Trial to Evaluate Sequential vs Simultaneous Patching

Conditions

Amblyopia patching glasses spectacles simultaneous sequential

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Randomized Trial to Evaluate Sequential vs Simultaneous Spectacles Plus Patching for Amblyopia in Children 3 to <13 Years Old

Quick Facts

Study Start:2020-12-08

Study Completion:2028-05-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04378790

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:3 Years to 13 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Age 3 to \<13 years at the time of randomization 2. Amblyopia associated with anisometropia, strabismus, or both * 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.	1. 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.

Inclusion Criteria

Exclusion Criteria

1. Age 3 to \<13 years at the time of randomization
2. Amblyopia associated with anisometropia, strabismus, or both
* 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.

1. 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.

Contacts and Locations

Study Contact

Raymond T Kraker, MSPH

CONTACT

813-975-8690

rkraker@jaeb.org

Brooke P Fimbel

CONTACT

813-975-8690

Principal Investigator

Vivian Manh

STUDY_CHAIR

Seattle Children's Hospital, University of Washington

Michael Gray

STUDY_CHAIR

Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

University of Alabama at Birmingham

Birmingham, Alabama, 35294

United States

Midwestern University Eye Institute

Glendale, Arizona, 85308

United States

University of Arizona

Tucson, Arizona, 85711

United States

Marshall B. Ketchum University

Fullerton, California, 92831

United States

Loma Linda University Health Care, Dept. of Ophthalmology

Loma Linda, California, 92354

United States

Stanford University

Palo Alto, California, 94303

United States

Western University College of Optometry

Pomona, California, 91766

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

St Luke's Hospital

Boise, Idaho, 83702

United States

Ticho Eye Associates

Chicago Ridge, Illinois, 60415

United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611

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

Helen DeVos Children's Hospital Pediatric Ophthalmology

Grand Rapids, Michigan, 49503

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

Saint Louis, Missouri, 63110

United States

U of MO St. Louis College of Optometry

Saint 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

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

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

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

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

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

Collaborators and Investigators

Sponsor: Jaeb Center for Health Research

Vivian Manh, STUDY_CHAIR, Seattle Children's Hospital, University of Washington
Michael Gray, STUDY_CHAIR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-08

Study Completion Date2028-05-31

Study Record Updates

Study Start Date2020-12-08

Study Completion Date2028-05-31

Terms related to this study

Keywords Provided by Researchers

patching
glasses
spectacles
simultaneous
sequential

Additional Relevant MeSH Terms

Amblyopia