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A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control

NCT07095894 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2026-04-07

No results posted yet for this study

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).

Conditions

  • Myopia

Interventions

DRUG

Atropine

Daily 0.05% atropine eyedrops

DEVICE

Spectacles with HAL

Spectacle lenses with highly aspherical lenslets (HAL)

DRUG

Placebo Eyedrops

Daily placebo eyedrops

Sponsors & Collaborators

  • Jaeb Center for Health Research

    lead OTHER

Principal Investigators

  • Lori Ann F Kehler, OD · Vanderbilt University Medical Center

  • Katherine A Lee, MD, PhD · Jaeb Center for Health Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2028-12-01
Completion
2029-06-01
FDA Drug
Yes
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07095894 on ClinicalTrials.gov