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A Randomized Trial to Evaluate Sequential vs Simultaneous Patching

RecruitingPhase 3

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

Who can join

Ages 3 to 13 · All sexes

Full eligibility criteria
Inclusion Criteria:

1. 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:

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.

About the study

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.

What is being tested

Sponsor: Jaeb Center for Health Research · Participants: 544 · Started: Dec 8, 2020

Contact the study team

Official record on ClinicalTrials.gov — NCT04378790

Locations in the U.S.

AlabamaUAB Pediatric Eye Care; Birmingham Health Care, Birmingham
University of Alabama at Birmingham, Birmingham
ArizonaMidwestern University Eye Institute, Glendale
Arizonia Pediatric Eye Specialists, Phoenix
University of Arizona, Tucson
CaliforniaUniv. of California- Berkeley, Berkeley
Marshall B. Ketchum University, Fullerton
Univ of California, Irvine- Gavin Herbert Eye Institute, Irvine
Loma Linda University Health Care, Dept. of Ophthalmology, Loma Linda
Children's Hospital of Los Angeles (CHLA), Los Angeles
Stanford University, Palo Alto
Western University College of Optometry, Pomona
University of California, Davis, Sacramento
University of California San Francisco Department of Ophthalmology, San Francisco
ConnecticutEye Physicians & Surgeons, PC, Milford
FloridaNova Southeastern University College of Optometry, The Eye Institute, Fort Lauderdale
Nemours Children's Clinic, Jacksonville
University of South Florida (USF) Eye, Tampa
IdahoSt Luke's Hospital, Boise
IllinoisAnn & Robert H. Lurie Children's Hospital of Chicago, Chicago
Ticho Eye Associates, Chicago Ridge
Midwestern U Chicago College of Optometry, Downers Grove
Progressive Eye Care, Lisle
IndianaIndiana School of Optometry, Bloomington
Indiana University School of Optometry, Indianapolis
IowaWolfe Eye Clinic, West Des Moines
MarylandWilmer Eye Institute, Baltimore
MassachusettsBoston Children's Hospital Waltham, Boston
Boston Medical Center, Boston
MichiganCorewell Health, Grand Rapids
Pediatric Ophthalmology, P.C., Grand Rapids
MinnesotaZenith Vision Development Center, Duluth
Mayo Clinic, Rochester
PineCone Vision Center, Sartell
MissouriChildren's Mercy Hospitals and Clinics, Kansas City
St. Louis Children's Hospital Eye Center, St Louis
U of MO St. Louis College of Optometry, St Louis
NebraskaUniversity of Nebraska Medical Center, Omaha
New YorkRoss Eye Institute, University of Buffalo, Med School Dept Ophthalmology, Buffalo
NYU Langone Health, New York
State University of New York, College of Optometry, New York
North CarolinaUniversity of North Carolina, Chapel Hill
Duke University Eye Center, Durham
OhioAkron Children's Hospital, Akron
Cincinnati Children's Hospital, Cincinnati
Ohio State University College of Optometry, Columbus
OklahomaDean A. McGee Eye Institute, Oklahoma City
OregonRiver View Family Eyecare, Albany
Casey Eye Institute, Portland
PennsylvaniaPediatric Ophthalmology of Erie, Erie
Conestoga Eye, Lancaster
Salus University/Pennsylvania College of Optometry, Philadelphia
Wills Eye Hospital, Philadelphia
UPMC Children's Eye Center of Children's Hospital of Pittsburgh, Pittsburgh
South CarolinaPrisma Health, Columbia
TennesseeSouthern College of Optometry, Memphis
Vanderbilt University Medical Center - Vanderbilt Eye Institute, Nashville
TexasPediatric Eye Specialists, LLP, Fort Worth
Baylor College of Medicine, Houston
Texas Tech University Health Science Center, Lubbock
San Antonio Eye Center, San Antonio
University of Incarnate Word Rosenberg School of Optometry, San Antonio
University of the Incarnate Word, San Antonio
UtahRocky Mountain Eye Care Associates, Salt Lake City
VirginiaVirginia Pediatric Eye Center, Norfolk
WashingtonSeattle Children's Hospital, University of Washington, Seattle
Spokane Eye Clinical Research, Spokane
WyomingSnowy Range Vision Center, Laramie

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.