Actively Recruiting
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
Led by Jaeb Center for Health Research · Updated on 2026-06-04
348
Participants Needed
12
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying children aged 5 to under 12 years with myopia to evaluate the effects of nightly low-concentration atropine eyedrops and specially designed spectacle lenses on slowing the progression of myopia. The study aims to assess these treatments during peak eye growth years, as previous trials have shown inconsistent results in non-Asian children. This phase 3 randomized clinical trial uses a 2x2 factorial design to compare atropine eyedrops, spectacle lenses with highly aspherical lenslets, their combination, and placebo treatments. Children first complete a run-in phase to show they can follow nightly artificial tear eyedrop use and wear spectacles consistently. Then, they are randomly assigned to one of four groups: 0.05% atropine eyedrops with standard single vision lenses, placebo eyedrops with single vision lenses, placebo eyedrops with highly aspherical lenslets, or atropine eyedrops with highly aspherical lenslets. Treatments are given nightly and spectacle lenses are worn during the 24-month treatment period. After this, children return for a 30-month visit following 6 months of no treatment except single vision spectacles. Participants visit the clinic every six months for 24 months, with a final visit at 30 months. At each visit, researchers measure changes in axial length of the eye (primary outcome) and refractive error (secondary outcome) to assess myopia progression. Throughout the trial, adherence to eyedrops and spectacle wear is monitored. Safety is checked regularly, including pregnancy tests for participants who have started menstruation. This study lasts about 30 months, including treatment, follow-up, and observation periods.
CONDITIONS
Brief Title
A RCT of Spectacles With Aspherical Lenslets or 0.05% Atropine for Myopia Control
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 5 years to under 12 years at enrollment
- Myopia between 0.75D and 6.00D spherical equivalent refractive error with at least 0.75D in both principal meridians of each eye
- Astigmatism less than 2.50D in both eyes
- Anisometropia less than 1.50D spherical equivalent refractive error
- Best-corrected distance visual acuity at age-normal levels in both eyes
- Wearing single-vision spectacles at least 90% of waking hours for 30 days before enrollment
- Gestational age at least 32 weeks
- Birth weight greater than 1500 grams
- Parent and child willing to accept randomization and study procedures
- Willingness to complete a 2- to 4-week run-in with nightly artificial tear eyedrops
- Ability to return within 2 to 4 weeks for randomization
- Child willing to avoid contact lens use during the study
- Parent has phone access and agrees to be contacted
- No anticipated relocation from active study area for 32 months
You will not qualify if you...
- Current or previous treatments for myopia such as pharmacologic or light therapy
- Contact lens wear more than 7 days in the past 12 months
- Use of bifocals, progressive lenses, multi-focal contact lenses, or focus/contrast-modifying spectacles
- Use of orthokeratology or rigid gas permeable lenses for myopia control
- Prior use of atropine, pirenzepine, or other anti-muscarinic agents
- Known allergy to atropine or shellfish
- Abnormalities of cornea, lens, retina, iris, or ciliary body
- Constant or intermittent strabismus (except phorias)
- History of amblyopia or nystagmus
- Prior eye surgeries including strabismus or refractive surgery
- Diagnosis of Down syndrome or cerebral palsy
- Diseases affecting eye accommodation, vergence, or motility
- Conditions affecting long-term eye health or requiring certain pharmacologic treatments
- Inability to understand or perform study procedures
- Pregnancy, lactation, or intention to become pregnant within 30 months
- Immediate family members employed at the research center or involved in the study
- Sibling or household member currently enrolled in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - 2 to 4 weeks
Participants complete a 2- to 4-week run-in period using nightly artificial tear eyedrops.
1 to 2 visits depending on scheduling
Duration - 24 months
Participants receive their assigned intervention: daily 0.05% atropine eyedrops, spectacles with highly aspherical lenslets, placebo eyedrops, or a combination of atropine and spectacles with highly aspherical lenslets to slow myopia progression.
Regular visits as scheduled during the 24-month treatment period
Trial Site Locations
Total: 12 locations
1
UAB Pediatric Eye Care; Birmingham Health Care
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
Marshall B. Ketchum University
Fullerton, California, United States, 92831
Actively Recruiting
3
Stanford University
Palo Alto, California, United States, 94303
Actively Recruiting
4
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
Actively Recruiting
5
Illinois College of Optometry
Chicago, Illinois, United States, 60616
Actively Recruiting
6
Boston Children's Hospital Waltham
Boston, Massachusetts, United States, 02453
Actively Recruiting
7
Duke University Eye Center
Durham, North Carolina, United States, 27710
Actively Recruiting
8
Pediatric Ophthalmology Associates, Inc.
Columbus, Ohio, United States, 43205
Actively Recruiting
9
Ohio State University College of Optometry
Columbus, Ohio, United States, 43210-1280
Actively Recruiting
10
Casey Eye Institute
Portland, Oregon, United States, 97239
Actively Recruiting
11
Vanderbilt University Medical Center - Vanderbilt Eye Institute
Nashville, Tennessee, United States, 37232
Actively Recruiting
12
University of Houston - College of Optometry
Houston, Texas, United States, 77204
Actively Recruiting
Research Team
R
Raymond T Kraker, MSPH
C
Courtney L Conner
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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