A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Start Date
6/1/2026
Completion Date
6/1/2029
Summary
To date, randomized trials of low-concentration atropine eyedrops and specially designed spectacle lenses to slow the progression of myopia are limited in number and results are inconsistent in non-Asian children. Although results of some recent randomized clinical trials outside the US are promising, additional studies in children are needed to test the safety and efficacy of low-concentration atropine and specially designed spectacle lenses as treatments to slow the progression of myopia during the peak years for eye growth. After a run-in phase to demonstrate adherence with nightly eyedrops (artificial tears) and spectacle correction, children 5 to \<12 years old with myopia of 0.75D to 6.00D cycloplegic spherical equivalent refractive error (SER) and at least 0.75D myopia in both principal meridians of each eye will be randomized in a 2x2 factorial design to treatment with 1) nightly 0.05% atropine or placebo eyedrops, and 2) spectacles with highly aspherical lenslet target (H.A.L.T.) MAX technology or single vision spectacles, and followed every six months for 24 months. Change in axial length over 24 months and change in SER over 24 months are the primary and secondary outcomes, respectively. All children will return for a visit at 30 months (after 6 months of no treatment other than single-vision spectacles alone between 24 and 30 months). The study is funded by the National Eye Institute, part of the NIH, and coordinated by the Jaeb Center for Health Research on behalf of PEDIG. Essilor International, a subsidiary of EssilorLuxottica, the manufacturer of Spectacle lenses with H.A.L.T.\* MAX technology, is providing the eyeglasses and financial support for the study. The 0.05% atropine eye drops used in the study are manufactured by Imprimis Rx, a subsidiary of Harrow, Inc.
Eligibility Criteria
Age Range: 5 years to 11 years
Interventions
Atropine
Spectacles with HAL
Placebo Eyedrops
Conditions
Locations
UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama 35294
United States
University of Arizona
Tucson, Arizona 85711
United States
Marshall B. Ketchum University
Fullerton, California 92831
United States
Stanford University
Palo Alto, California 94303
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
Boston Children's Hospital Waltham
Boston, Massachusetts 02453
United States
Corewell Health
Grand Rapids, Michigan 49503
United States
Duke University Eye Center
Durham, North Carolina 27710
United States
Pediatric Ophthalmology Associates, Inc.
Columbus, Ohio 43205
United States
Ohio State University College of Optometry
Columbus, Ohio 43210-1280
United States
Casey Eye Institute
Portland, Oregon 97239
United States
Pennsylvania College of Optometry, Salus at Drexel University
Philadelphia, Pennsylvania 19141
United States
Vanderbilt University Medical Center - Vanderbilt Eye Institute
Nashville, Tennessee 37232
United States
University of Houston - College of Optometry
Houston, Texas 77204
United States
Rocky Mountain Eye Care Associates
Salt Lake City, Utah 84107
United States
Virginia Pediatric Eye Center
Norfolk, Virginia 23502
United States