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Study of Spectacles or Atropine Eyedrops for Myopia Control

This study is testing two ways to slow down myopia (nearsightedness) in children: special spectacle lenses with highly aspherical lenslets (HAL) or daily 0.05% atropine eyedrops. Researchers want to see if these treatments are safe and effective for children aged 5 to under 12 years old who have myopia ranging from 0.75D to 6.00D. A third group will receive placebo eyedrops. The main goal is to measure how much the eye's length changes over 24 months, as this indicates myopia progression. This research is important because current studies on these treatments in non-Asian children have had mixed results, and more information is needed.

Study design
This is a randomized controlled trial, meaning participants will be assigned by chance to one of three groups. The study plans to enroll 348 children.
What's involved
Participants will need to demonstrate they can consistently use nightly eyedrops (artificial tears) and wear their spectacles before starting the study. The primary outcome will be measured at 24 months.
Compensation
Not stated in the trial record.
Follow-up
The main measurement of the study, change in axial length, will be taken at 24 months.

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NCT07095894

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

Recruiting
PHASE3Ages 5–11InterventionalTreatment
Jaeb Center for Health Research
~348 participants
Updated 2026-06-26 on ClinicalTrials.gov
What's tested:AtropineSpectacles with HALPlacebo Eyedrops

At a glance

Recruiting sites
17 of 17 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary efficacy outcome - change in axial length
Measured over 24 months.

Conditions

Myopia

Explore related trials

Myopia

Where it's being run

17 sites across 14 states
California2
Illinois2
Ohio2
Alabama1
Arizona1
Massachusetts1
Michigan1
North Carolina1

Study leadership

  • Lori Ann F Kehler, OD · STUDY_CHAIR · Vanderbilt University Medical Center
  • Katherine A Lee, MD, PhD · STUDY_CHAIR · Jaeb Center for Health Research

Who to contact

Raymond T Kraker, MSPH
[email protected]
813-975-8690
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Myopia of 0.75D to 6.00D SER and at least 0.75D in both principal meridians of each eye
Astigmatism \<2.50D both eyes
Anisometropia \<1.50D SER 3. Investigator has confirmed the following regarding best-corrected distance visual acuity (VA) in habitual spectacles or trial frames using the investigator's preferred VA testing method:
VA is age normal in both eyes1,2
5-6 years: approximately 20/32 or better, ≤ 0.24 logMAR, ≥ 73 letters
7-12 years: approximately 20/25 or better, ≤ 0.14 logMAR, ≥ 78 letters
Interocular difference ≤2 logMAR lines (0.2 logMAR) or ≤ 10 letters

What this trial measures

  • Primary efficacy outcome - change in axial length24 months.

    Change in axial length from baseline to 24 months (on-treatment) as measured by a masked examiner using cycloplegic biometry.