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

NCT07095894 | Not Yet Recruiting Phase 3 DMC FDA Drug FDA Device

• 1 other identifier: MTS2
• Study Type: interventional
• Target: 348
• Locations: 0 countries
• Sites: N/A

Brief 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 lenslets (HAL) 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

Keywords

myopia; spectacles; atropine; pediatric

Outcome Measures

Primary Outcomes (1)

• Primary efficacy outcome - change in axial length

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

  24 months.

Study Arms (4)

Atropine Group

EXPERIMENTAL

Daily low-concentration atropine (0.05%) eyedrops plus spectacles with single vision lenses (SVL)

Drug: Atropine

Placebo Group

PLACEBO COMPARATOR

Daily placebo eyedrops plus spectacles with single-vision lenses (SVL)

Drug: Placebo Eyedrops

HAL Group

EXPERIMENTAL

Daily placebo eyedrops plus spectacles with highly aspherical lenslets

Device: Spectacles with HAL; Drug: Placebo Eyedrops

Combined Group

EXPERIMENTAL

Daily low-concentration atropine (0.05%) eyedrops plus spectacles with highly aspherical lenslets

Drug: Atropine; Device: Spectacles with HAL

Interventions

Atropine DRUG

Daily 0.05% atropine eyedrops

Atropine Group; Combined Group

Spectacles with HAL DEVICE

Spectacle lenses with highly aspherical lenslets (HAL)

Combined Group; HAL Group

Placebo Eyedrops DRUG

Daily placebo eyedrops

HAL Group; Placebo Group

Eligibility Criteria

• Age: 5 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 5 years to \<12 years at time of enrollment. Children within 4 weeks of their 12th birthday are not eligible.
• Refractive error meeting the following by cycloplegic autorefraction:
• 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
• 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
• years: approximately 20/32 or better, ≤ 0.24 logMAR, ≥ 73 letters
• years: approximately 20/25 or better, ≤ 0.14 logMAR, ≥ 78 letters
• Interocular difference ≤2 logMAR lines (0.2 logMAR) or ≤ 10 letters
• Gestational age ≥ 32 weeks.
• Birth weight \>1500 g.
• Parent(s) and assenting child understand the study procedures and are willing to accept randomization to atropine 0.05%, HAL lenses, atropine combined with HAL lenses, or placebo (i.e., neither active treatment).
• Parent is willing to participate in a 2- to 4-week run-in phase using nightly artificial tear eyedrops in both eyes.
• Family can return in 2 to 4 weeks for possible randomization.

You may not qualify if:

• Current or previous pharmacologic or light therapy used for myopia treatment.
• Current or prior contact lens wear more than 7 days in the past 12 months
• Current or previous use of bifocals, progressive-addition lenses, multi-focal contact lenses, or focus- or contrast-modifying spectacle lenses.
• Current or previous use of orthokeratology, rigid gas permeable, or other contact lenses used to slow myopia progression.
• Current or previous myopia control treatment or other uses of atropine, pirenzepine or other anti-muscarinic agents.
• Known atropine allergy
• Abnormality of the cornea, lens, central retina, iris, or ciliary body
• Current constant or intermittent strabismus (phorias are acceptable)
• Verified history of amblyopia or nystagmus.
• Prior strabismus, intraocular, or refractive surgery
• Down syndrome or cerebral palsy
• Diseases known to affect accommodation, vergence, or ocular motility (e.g., multiple sclerosis, Graves' disease, myasthenia gravis, diabetes mellitus)
• Any condition that, in the judgment of the investigator, could influence refractive error development.
• Existing conditions in the opinion of the investigator that may affect the long-term health of the eye or require regular pharmacologic treatment that may adversely interact with study medication (e.g., JIA, glaucoma, pre-diabetes).
• Inability to comprehend and/or perform any study-related procedures.

Sponsors & Collaborators

• Jaeb Center for Health Research: lead

MeSH Terms

Conditions

Myopia

Interventions

Atropine; Eyeglasses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Lori Ann F Kehler, OD

  Vanderbilt University Medical Center

  STUDY CHAIR

• Katherine A Lee, MD, PhD

  Jaeb Center for Health Research

  STUDY CHAIR

Central Study Contacts

Raymond T Kraker, MSPH

CONTACT

813-975-8690; rkraker@jaeb.org

Courtney L Conner

CONTACT

813-975-8690; cconner@jaeb.org

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 31, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF