A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Public ClinicalTrials.gov record NCT07095894. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT07095894
- Recruitment status
- Recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 348 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 5 Years to 11 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2026
- Primary completion
- Nov 30, 2028
- Completion
- May 31, 2029
- Last update posted
- Jun 25, 2026
2026 – 2029
United States locations
- U.S. sites
- 17
- U.S. states
- 14
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UAB Pediatric Eye Care; Birmingham Health Care | Birmingham | Alabama | 35294 | Recruiting |
| University of Arizona | Tucson | Arizona | 85711 | Recruiting |
| Marshall B. Ketchum University | Fullerton | California | 92831 | Recruiting |
| Stanford University | Palo Alto | California | 94303 | Recruiting |
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | Recruiting |
| Illinois College of Optometry | Chicago | Illinois | 60616 | Recruiting |
| Boston Children's Hospital Waltham | Boston | Massachusetts | 02453 | Recruiting |
| Corewell Health | Grand Rapids | Michigan | 49503 | Recruiting |
| Duke University Eye Center | Durham | North Carolina | 27710 | Recruiting |
| Pediatric Ophthalmology Associates, Inc. | Columbus | Ohio | 43205 | Recruiting |
| Ohio State University College of Optometry | Columbus | Ohio | 43210-1280 | Recruiting |
| Casey Eye Institute | Portland | Oregon | 97239 | Recruiting |
| Pennsylvania College of Optometry, Salus at Drexel University | Philadelphia | Pennsylvania | 19141 | Recruiting |
| Vanderbilt University Medical Center - Vanderbilt Eye Institute | Nashville | Tennessee | 37232 | Recruiting |
| University of Houston - College of Optometry | Houston | Texas | 77204 | Recruiting |
| Rocky Mountain Eye Care Associates | Salt Lake City | Utah | 84107 | Recruiting |
| Virginia Pediatric Eye Center | Norfolk | Virginia | 23502 | Recruiting |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT07095894, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 25, 2026 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT07095894 live on ClinicalTrials.gov.