A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
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
1 other identifier
interventional
348
1 country
17
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2026
Typical duration for phase_3
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2025
CompletedFirst Posted
Study publicly available on registry
July 31, 2025
CompletedStudy Start
First participant enrolled
June 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
June 26, 2026
June 1, 2026
2.5 years
July 21, 2025
June 23, 2026
Conditions
Keywords
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
EXPERIMENTALDaily low-concentration atropine (0.05%) eyedrops plus spectacles with single vision lenses (SVL)
Placebo Group
PLACEBO COMPARATORDaily placebo eyedrops plus spectacles with single-vision lenses (SVL)
HAL Group
EXPERIMENTALDaily placebo eyedrops plus spectacles with highly aspherical lenslets
Combined Group
EXPERIMENTALDaily low-concentration atropine (0.05%) eyedrops plus spectacles with highly aspherical lenslets
Interventions
Spectacle lenses with highly aspherical lenslets (HAL)
Eligibility Criteria
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.
- +3 more criteria
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
- Known allergy to shellfish
- 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).
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama, 35294, United States
University of Arizona
Tucson, Arizona, 85711, United States
Marshall B. Ketchum University
Fullerton, California, 92831, United States
Stanford University
Palo Alto, California, 94303, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Illinois College of Optometry
Chicago, Illinois, 60616, United States
Boston Children's Hospital Waltham
Boston, Massachusetts, 02453, United States
Corewell Health
Grand Rapids, Michigan, 49503, United States
Duke University Eye Center
Durham, North Carolina, 27710, United States
Pediatric Ophthalmology Associates, Inc.
Columbus, Ohio, 43205, United States
Ohio State University College of Optometry
Columbus, Ohio, 43210-1280, United States
Casey Eye Institute
Portland, Oregon, 97239, United States
Pennsylvania College of Optometry, Salus at Drexel University
Philadelphia, Pennsylvania, 19141, United States
Vanderbilt University Medical Center - Vanderbilt Eye Institute
Nashville, Tennessee, 37232, United States
University of Houston - College of Optometry
Houston, Texas, 77204, United States
Rocky Mountain Eye Care Associates
Salt Lake City, Utah, 84107, United States
Virginia Pediatric Eye Center
Norfolk, Virginia, 23502, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Lori Ann F Kehler, OD
Vanderbilt University Medical Center
- STUDY CHAIR
Katherine A Lee, MD, PhD
Jaeb Center for Health Research
Central Study Contacts
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
June 1, 2026
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
June 1, 2029
Last Updated
June 26, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF