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

Status: Recruiting
Location: See all (68) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 13
Healthy Volunteers: f
View:

• Age 3 to \<13 years at the time of randomization

• 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

• No previous treatment for amblyopia, including no more than 24 hours of spectacle wear.

• 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:

∙ Full correction of anisometropia

‣ Full correction of astigmatism with the same axis found by the cycloplegic refraction

‣ Full correction of any myopia

‣ Hyperopia must not be under corrected by more than 1.50 D, and reduction in plus sphere must be symmetric in the two eyes.

• 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

∙ 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).

• Investigator is willing to prescribe spectacle wear followed sequentially by patching or simultaneous spectacles and patching treatment 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 staff or other study staff.

• Relocation outside of area of an active PEDIG site for this study within the next 56 weeks is not anticipated.

Locations
United States
Alabama
UAB Pediatric Eye Care; Birmingham Health Care
RECRUITING
Birmingham
University of Alabama at Birmingham
RECRUITING
Birmingham
Arizona
Midwestern University Eye Institute
RECRUITING
Glendale
Arizonia Pediatric Eye Specialists
RECRUITING
Phoenix
University of Arizona
RECRUITING
Tucson
California
Univ. of California- Berkeley
RECRUITING
Berkeley
Marshall B. Ketchum University
RECRUITING
Fullerton
Univ of California, Irvine- Gavin Herbert Eye Institute
RECRUITING
Irvine
Loma Linda University Health Care, Dept. of Ophthalmology
RECRUITING
Loma Linda
Children's Hospital of Los Angeles (CHLA)
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
Eye Physicians & Surgeons, PC
RECRUITING
Milford
Florida
Nova Southeastern University College of Optometry, The Eye Institute
RECRUITING
Fort Lauderdale
Nemours Children's Clinic
RECRUITING
Jacksonville
University of South Florida (USF) Eye
RECRUITING
Tampa
Iowa
Wolfe Eye Clinic
RECRUITING
West Des Moines
Idaho
St Luke's Hospital
RECRUITING
Boise
Illinois
Ann & Robert H. Lurie Children's Hospital of Chicago
RECRUITING
Chicago
Ticho Eye Associates
RECRUITING
Chicago Ridge
Midwestern U Chicago College of Optometry
RECRUITING
Downers Grove
Progressive Eye Care
RECRUITING
Lisle
Indiana
Indiana School of Optometry
RECRUITING
Bloomington
Indiana University School of Optometry
RECRUITING
Indianapolis
Massachusetts
Boston Children's Hospital Waltham
RECRUITING
Boston
Boston Medical Center
RECRUITING
Boston
Maryland
Wilmer Eye Institute
RECRUITING
Baltimore
Michigan
Corewell Health
RECRUITING
Grand Rapids
Pediatric Ophthalmology, P.C.
RECRUITING
Grand Rapids
Minnesota
Zenith Vision Development Center
RECRUITING
Duluth
Mayo Clinic
RECRUITING
Rochester
PineCone Vision Center
RECRUITING
Sartell
Missouri
Children's Mercy Hospitals and Clinics
RECRUITING
Kansas City
St. Louis Children's Hospital Eye Center
RECRUITING
St Louis
U of MO St. Louis College of Optometry
RECRUITING
St Louis
North Carolina
University of North Carolina
RECRUITING
Chapel Hill
Duke University Eye Center
RECRUITING
Durham
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
Akron Children's Hospital
RECRUITING
Akron
Cincinnati Children's Hospital
RECRUITING
Cincinnati
Ohio State University College of Optometry
RECRUITING
Columbus
Oklahoma
Dean A. McGee Eye Institute
RECRUITING
Oklahoma City
Oregon
River View Family Eyecare
RECRUITING
Albany
Casey Eye Institute
RECRUITING
Portland
Pennsylvania
Pediatric Ophthalmology of Erie
RECRUITING
Erie
Conestoga Eye
RECRUITING
Lancaster
Salus University/Pennsylvania College of Optometry
RECRUITING
Philadelphia
Wills Eye Hospital
RECRUITING
Philadelphia
UPMC Children's Eye Center of Children's Hospital of Pittsburgh
RECRUITING
Pittsburgh
South Carolina
Prisma Health
RECRUITING
Columbia
Tennessee
Southern College of Optometry
RECRUITING
Memphis
Vanderbilt University Medical Center - Vanderbilt Eye Institute
RECRUITING
Nashville
Texas
Pediatric Eye Specialists, LLP
RECRUITING
Fort Worth
Baylor College of Medicine
RECRUITING
Houston
Texas Tech University Health Science Center
RECRUITING
Lubbock
San Antonio Eye Center
RECRUITING
San Antonio
University of Incarnate Word Rosenberg School of Optometry
RECRUITING
San Antonio
University of the Incarnate Word
RECRUITING
San Antonio
Utah
Rocky Mountain Eye Care Associates
RECRUITING
Salt Lake City
Virginia
Virginia Pediatric Eye Center
RECRUITING
Norfolk
Washington
Seattle Children's Hospital, University of Washington
RECRUITING
Seattle
Spokane Eye Clinical Research
RECRUITING
Spokane
Wyoming
Snowy Range Vision Center
RECRUITING
Laramie
Contact Information
Primary
Raymond T Kraker, MSPH
rkraker@jaeb.org
813-975-8690
Backup
Brooke P Fimbel
813-975-8690
Time Frame
Start Date: 2020-12-08
Estimated Completion Date: 2028-05-01
Participants
Target number of participants: 544
Treatments
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
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