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

Status: Recruiting
Location: See all (64) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 4
Maximum Age: 7
Healthy Volunteers: f
View:

• Age 4 to 7 years.

• 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:

∙ VA in the amblyopic eye 20/40 to 20/200 inclusive.

‣ 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

‣ Interocular difference ≥ 3 logMAR lines (i.e., amblyopic eye VA at least 3 logMAR lines worse than fellow eye VA).

• Amblyopia associated with strabismus, anisometropia, or both (previously treated or untreated).

∙ 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).

‣ 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: 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.

• No more than 2 weeks (cumulative) of prior dichoptic treatment.

• No treatment with cycloplegic eyedrops (e.g., atropine) in the past 2 weeks; other treatments allowed up to enrollment but then must be discontinued.

• 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).

‣ 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.

‣ 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.

• Participant is willing to wear the Luminopia headset.

• Participant is willing to continue full-time spectacles/contact lens wear (if needed).

• 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.

⁃ Interpupillary distance of 52mm to 72mm inclusive.

⁃ Investigator is willing to prescribe Luminopia or patching per protocol.

⁃ Parent understands the protocol and is willing to accept randomization.

⁃ Parent has phone (or access to phone) and is willing to be contacted by JAEB Center.

⁃ 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.

• Heterotropia more than 5∆ at distance or near (measured by SPCT in current correction)

• Prism lenses or need of a prism prescription at enrollment.

• Current bifocal spectacles (eligible only if bifocal discontinued 2 weeks prior to enrollment).

• Myopia greater than -6.00D spherical equivalent in either eye.

• Previous intraocular or refractive surgery.

• Known skin reactions to patch or bandage adhesives.

• 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).

• Diplopia more than once per week over the last week prior to enrollment by parental report.

• History of light-induced seizures.

⁃ 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.

⁃ Participation in a prior study involving patching for amblyopia

⁃ 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.

Locations
United States
Alabama
UAB Pediatric Eye Care; Birmingham Health Care
RECRUITING
Birmingham
Arkansas
Arkansas Childrens
RECRUITING
Little Rock
McFarland Eye Care Center
RECRUITING
Little Rock
Arizona
Midwestern University Eye Institute
RECRUITING
Glendale
University of Arizona
RECRUITING
Tucson
California
Univ. of California- Berkeley
RECRUITING
Berkeley
Southern California College of Optometry
RECRUITING
Fullerton
Univ of California, Irvine- Gavin Herbert Eye Institute
RECRUITING
Irvine
Children's Hospital of Los Angeles (CHLA)
RECRUITING
Los Angeles
Jules Stein Eye Institute at the University of California, Los Angeles
RECRUITING
Los Angeles
Stanford University
RECRUITING
Palo Alto
Western University College of Optometry
RECRUITING
Pomona
University of California, Davis
RECRUITING
Sacramento
University of California San Francisco Department of Ophthalmology
RECRUITING
San Francisco
Connecticut
Yale University
RECRUITING
New Haven
Florida
University of South Florida (USF) Eye
RECRUITING
Tampa
Iowa
University of Iowa
RECRUITING
Iowa City
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Illinois College of Optometry
RECRUITING
Chicago
Progressive Eye Care
RECRUITING
Lisle
Indiana
Indiana School of Optometry
RECRUITING
Bloomington
Massachusetts
Specialized Pediatric Eye Care
RECRUITING
Beverly
Boston Children's Hospital Waltham
RECRUITING
Boston
Boston Medical Center
RECRUITING
Boston
New England College of Optometry
RECRUITING
Boston
Maryland
Greater Baltimore Medical Center
RECRUITING
Baltimore
Wilmer Eye Institute
RECRUITING
Baltimore
Michigan
Michigan College of Optometry at Ferris State Univ
RECRUITING
Big Rapids
Corewell Health
RECRUITING
Grand Rapids
Pediatric Ophthalmology, P.C.
RECRUITING
Grand Rapids
Children's Eye Care PC
RECRUITING
West Bloomfield
Minnesota
Zenith Vision Development Center
RECRUITING
Duluth
University of Minnesota
RECRUITING
Minneapolis
Mayo Clinic Department of Ophthalmology
RECRUITING
Rochester
PineCone Vision Center
RECRUITING
Sartell
Missouri
Children's Mercy Hospitals and Clinics
RECRUITING
Kansas City
Children's Mercy Hospitals and Clinics
RECRUITING
Kansas City
North Carolina
Duke University Eye Center
RECRUITING
Durham
North Dakota
University of North Dakota
RECRUITING
Grand Forks
Nebraska
University of Nebraska Medical Center
RECRUITING
Omaha
New York
Ross Eye Institute, University of Buffalo, Med School Dept Ophthalmology
RECRUITING
Buffalo
NYU Langone Health
RECRUITING
New York
State University of New York, College of Optometry
RECRUITING
New York
Ohio
Cincinnati Children's Hospital
RECRUITING
Cincinnati
Cole Eye Institute
RECRUITING
Cleveland
Ohio State University College of Optometry
RECRUITING
Columbus
Pediatric Ophthalmology Associates, Inc.
RECRUITING
Columbus
Rainbow Babies and Children's Hospital Dept of Ophth
RECRUITING
Mayfield Heights
Eye Care Associates, Inc.
RECRUITING
Poland
Oregon
Casey Eye Institute
RECRUITING
Portland
Pennsylvania
Pediatric Ophthalmology of Erie
RECRUITING
Erie
Conestoga Eye
RECRUITING
Lancaster
Wills Eye Hospital
RECRUITING
Philadelphia
South Carolina
Prisma Health
RECRUITING
Columbia
Tennessee
Southern College of Optometry
RECRUITING
Memphis
Vanderbilt Children's Hospital
RECRUITING
Nashville
Texas
Texas Children's Hospital - Dept. Of Ophthalmology
RECRUITING
Houston
Texas Tech University Health Science Center
RECRUITING
Lubbock
University of the Incarnate Word
RECRUITING
San Antonio
Virginia
Earl R. Crouch, III
RECRUITING
Norfolk
Virginia Pediatric Eye Center
RECRUITING
Norfolk
Washington
Seattle Children's Hospital, University of Washington
RECRUITING
Seattle
Spokane Eye Clinical Research
RECRUITING
Spokane
Wisconsin
Gundersen Health System
RECRUITING
La Crosse
Contact Information
Primary
Raymond T Kraker, MSPH
rkraker@jaeb.org
813-975-8690
Backup
Brooke P Fimbel
bfimmel@jaeb.org
813-975-8690
Time Frame
Start Date: 2024-07-11
Estimated Completion Date: 2027-05-01
Participants
Target number of participants: 238
Treatments
Experimental: Luminopia Group
watching dichoptic movies/shows wearing the Luminopia headset prescribed 1 hour per day (treatment time can be split into shorter sessions totaling 1 hour each day) 6 days a week with optical correction, if needed.
Active_comparator: Patching Group
patching of the fellow eye 2 hours per day (treatment time can be split into shorter sessions totaling 2 hours each day) 7 days per week with optical correction, if needed.
Related Therapeutic Areas
Sponsors
Collaborators: Pediatric Eye Disease Investigator Group, National Eye Institute (NEI)
Leads: Jaeb Center for Health Research

This content was sourced from clinicaltrials.gov

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