A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control (NCT07095894)
A Randomized Placebo-controlled Trial of Spectacles With Highly Aspherical Lenslet Target (H.A.L.T.) MAX Technology or 0.05% Atropine to Slow Progression of Myopia in Children
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: UAB Pediatric Eye Care; Birmingham Health Care — Birmingham, Alabama
Age range: 5 Years to 11 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (17 Sites)
- UAB Pediatric Eye Care; Birmingham Health Care — Birmingham, Alabama
- University of Arizona — Tucson, Arizona
- Marshall B. Ketchum University — Fullerton, California
- Stanford University — Palo Alto, California
- Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois
- Illinois College of Optometry — Chicago, Illinois
- Boston Children's Hospital Waltham — Boston, Massachusetts
- Corewell Health — Grand Rapids, Michigan
- Duke University Eye Center — Durham, North Carolina
- Pediatric Ophthalmology Associates, Inc. — Columbus, Ohio
- Ohio State University College of Optometry — Columbus, Ohio
- Casey Eye Institute — Portland, Oregon
- Pennsylvania College of Optometry, Salus at Drexel University — Philadelphia, Pennsylvania
- Vanderbilt University Medical Center - Vanderbilt Eye Institute — Nashville, Tennessee
- University of Houston - College of Optometry — Houston, Texas
- Rocky Mountain Eye Care Associates — Salt Lake City, Utah
- Virginia Pediatric Eye Center — Norfolk, Virginia
📞 Contact the Study Coordinator
Phone: (813) 975-8690
Email: rkraker@jaeb.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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Explore by condition: All Myopia clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.