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NCT06380517PHASE3Recruiting

Dichoptic Treatment for Amblyopia in Children 4 to 7 Years of Age

Jaeb Center for Health Research

Start Date

7/1/2024

Completion Date

1/1/2028

Summary

In children 4 to 7 years of age, to determine if treatment with 1 hour per day 6 days per week of watching dichoptic movies/shows wearing the Luminopia headset is non-inferior to treatment with 2 hours of patching per day 7 days per week with respect to change in amblyopic eye distance VA from randomization to 26 weeks.

Detailed Description

Participants eligible for the study will be randomly allocated (1:1) to receive either dichoptic treatment while wearing the Luminopia headset or patching treatment of the fellow eye for amblyopia with clinical assessments at 13, and 26-weeks post-randomization. At the 26-week primary outcome visit, participants who were randomly assigned to receive patching treatment with an IOD of 1 logMAR line or more, will be offered Luminopia dichoptic therapy and if they accept, followed forward with visits at 39- and 52-weeks post-randomization. The study will end for all other participants.

Eligibility Criteria

Age Range: 4 years to 7 years

At the time of enrollment, individuals must meet all the following inclusion criteria to be eligible to participate in the study. 1. Age 4 to 7 years. 2. Visual acuity, measured in each eye without cycloplegia in current refractive correction (if applicable) using the ATS-HOTV VA protocol on a study-approved device displaying single surrounded optotypes, as follows: 1. VA in the amblyopic eye 20/40 to 20/200 inclusive. 2. Age-normal VA in the fellow eye:44,45 • 4 years: 20/40 or better; 5-6 years: 20/32 or better; 7 years: 20/25 or better 3. Interocular difference ≥ 3 logMAR lines (i.e., amblyopic eye VA at least 3 logMAR lines worse than fellow eye VA). 3. Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated). 1. 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 optical correction), must be \<=5 prism diopters (∆) by SPCT at distance and near fixation (see #7 below). * Documented history of strabismus which is no longer present (which in the judgment of the investigator could have caused amblyopia). 2. 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. 3. Criteria for combined-mechanism: Both of the following criteria must be met: * A criterion for strabismus is 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. 4. No more than 2 weeks (cumulative) of prior dichoptic treatment. 5. No treatment with cycloplegic eyedrops (e.g., atropine) in the past 2 weeks; other treatments allowed up to enrollment but then must be discontinued. 6. Refractive correction is required (single vision lenses or contact lenses) for any of the following refractive errors based on a cycloplegic refraction completed within the last 7 months: * Hypermetropia of 2.50 D or more by SE * Myopia of amblyopic eye of 0.50D or more SE * Astigmatism of 1.00D or more * Anisometropia of more than 0.50D SE NOTE: Monocular or binocular contact lens wear is allowed provided the contact lenses meet the refractive error correction requirements below. For each child, all testing must be performed using the same form of optical correction (i.e., no changing between contacts and spectacles). 1. Spectacles/contact lens correction prescribing instructions referenced to the cycloplegic refraction completed within the last 7 months: * SE must be within 0.50D of fully correcting the anisometropia (if new glasses are prescribed, reduction in plus sphere must be symmetric in the two eyes). * SE must not be under corrected by more than 1.50D SE. * Cylinder power in both eyes must be within 0.50D of fully correcting the astigmatism. * Axis must be within +/- 10 degrees if cylinder power is ≤1.00D, and within +/- 5 degrees if cylinder power is \>1.00D. * Myopia must not be under corrected by more than 0.25D or over corrected by more than 0.50D SE, and any change must be symmetrical in the two eyes. 2. Spectacles/contact lens correction (with or without other treatment such as patching) meeting the above criteria must be worn: * For at least 18 weeks OR until VA stability is documented (defined as \<0.1 logMAR change by the same testing method measured on 2 consecutive exams at least 9 weeks apart). * For determining VA stability (non-improvement): * The first of two measurements may be made 1) in current correction, or 2) in trial frames with or without cycloplegia or 3) without correction (if new correction is prescribed), * The second measurement must be made without cycloplegia in the correct spectacles/contact lens correction that has been worn for at least 9 weeks. * NOTE: Because this determination is a pre-randomization, the method of measuring VA is not mandated. 7. Participant is willing to wear the Luminopia headset. 8. Participant is willing to continue full-time spectacles/contact lens wear (if needed). 9. Participant is willing to accept assignment to either dichoptic shows (view 1 hour per day 6 days per week) OR part-time patching (2 hours per day 7 days per week) for 26 weeks. 10. Interpupillary distance of 52mm to 72mm inclusive. 11. Investigator is willing to prescribe Luminopia or patching per protocol. 12. Parent understands the protocol and is willing to accept randomization. 13. Parent has phone (or access to phone) and is willing to be contacted by JAEB Center. 14. Relocation outside area of active PEDIG site within the next 52 weeks is not anticipated. Individuals meeting any of the following criteria will be excluded from study participation. 1. Heterotropia more than 5∆ at distance or near (measured by SPCT in current correction) 2. Prism lenses or need of a prism prescription at enrollment. 3. Current bifocal spectacles (eligible only if bifocal discontinued 2 weeks prior to enrollment). 4. Myopia greater than -6.00D spherical equivalent in either eye. 5. Previous intraocular or refractive surgery. 6. Known skin reactions to patch or bandage adhesives. 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 visual acuity criteria are met using patch occlusion. Fogging is not permitted). 8. Diplopia more than once per week over the last week prior to enrollment by parental report. 9. History of light-induced seizures. 10. 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 are not excluded. 11. Participation in a prior study involving patching for amblyopia 12. Immediate family member (biological or legal guardian, child, sibling, parent) of investigative site personnel directly affiliated with this study or an employee of the JAEB center for Health Research.

Interventions

DEVICE

Luminopia

OTHER

Eye Patch

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Conditions

Amblyopia

Locations

UAB Pediatric Eye Care; Birmingham Health Care

Birmingham, Alabama 35294

United States

Midwestern University Eye Institute

Glendale, Arizona 85308

United States

Phoenix Children's Medical Group - Ophthalmology

Scottsdale, Arizona 85255

United States

University of Arizona

Tucson, Arizona 85711

United States

Arkansas Childrens

Little Rock, Arkansas 72202

United States

McFarland Eye Care Center

Little Rock, Arkansas 72205

United States

Univ. of California- Berkeley

Berkeley, California 94720

United States

Southern California College of Optometry

Fullerton, California 92831-1699

United States

Univ of California, Irvine- Gavin Herbert Eye Institute

Irvine, California 92697

United States

Children's Hospital of Los Angeles (CHLA)

Los Angeles, California 90027

United States

Jules Stein Eye Institute at the University of California, Los Angeles

Los Angeles, California 90095

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

Rady Children's Hospital - San Diego Dept of Ophthalmology

San Diego, California 92123

United States

University of California San Francisco Department of Ophthalmology

San Francisco, California 94143

United States

Yale University

New Haven, Connecticut 06511

United States

University of South Florida (USF) Eye

Tampa, Florida 33620

United States

The Emory Eye Center

Atlanta, Georgia 30322

United States

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

Chicago, Illinois 60611

United States

Illinois College of Optometry

Chicago, Illinois 60616

United States

Midwestern University Eye Institute

Downers Grove, Illinois 60515

United States

Progressive Eye Care

Lisle, Illinois 60532

United States

Indiana School of Optometry

Bloomington, Indiana 47405

United States

University of Iowa

Iowa City, Iowa 52242

United States

University of Kansas Dept of Ophthalmology

Prairie Village, Kansas 66208

United States

Greater Baltimore Medical Center

Baltimore, Maryland 21204-5809

United States

Wilmer Eye Institute

Baltimore, Maryland 21287-9028

United States

Specialized Pediatric Eye Care

Beverly, Massachusetts 01915

United States

New England College of Optometry

Boston, Massachusetts 02115

United States

Boston Medical Center

Boston, Massachusetts 02118

United States

Boston Children's Hospital Waltham

Boston, Massachusetts 02453

United States

University of Michigan

Ann Arbor, Michigan 48105

United States

Michigan College of Optometry at Ferris State Univ

Big Rapids, Michigan 49307

United States

Corewell Health

Grand Rapids, Michigan 49503

United States

Pediatric Ophthalmology, P.C.

Grand Rapids, Michigan 49546

United States

Children's Eye Care PC

West Bloomfield, Michigan 48322

United States

Zenith Vision Development Center

Duluth, Minnesota 55811

United States

University of Minnesota

Minneapolis, Minnesota 55454

United States

Mayo Clinic Department of Ophthalmology

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

Children's Mercy Hospitals and Clinics

Kansas City, Missouri 64108

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

University of North Dakota

Grand Forks, North Dakota 58202

United States

Cincinnati Children's Hospital

Cincinnati, Ohio 45229

United States

Cole Eye Institute

Cleveland, Ohio 44195

United States

Pediatric Ophthalmology Associates, Inc.

Columbus, Ohio 43205

United States

Ohio State University College of Optometry

Columbus, Ohio 43210-1280

United States

Rainbow Babies and Children's Hospital Dept of Ophth

Mayfield Heights, Ohio 44124

United States

Eye Care Associates, Inc.

Poland, Ohio 44514

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

Pennsylvania College of Optometry, Salus at Drexel University

Philadelphia, Pennsylvania 19141

United States

Prisma Health

Columbia, South Carolina 29203

United States

Storm Eye Institute

Mt. Pleasant, South Carolina 29464

United States

Southern College of Optometry

Memphis, Tennessee 38104

United States

Vanderbilt Children's Hospital

Nashville, Tennessee 37232-8808

United States

Texas Children's Hospital - Dept. Of Ophthalmology

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

Earl R. Crouch, III

Norfolk, Virginia 23502-3942

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

Gundersen Health System

La Crosse, Wisconsin 54601

United States