What is atropine studying for myopia in children?

This trial is studying how low-concentration atropine eyedrops and special spectacle lenses may slow the progression of myopia in children aged 5 to under 12 years. Researchers want to evaluate if these treatments can reduce eye growth linked to worsening nearsightedness. The Jaeb Center for Health Research is leading this study to improve options for myopia control in children.

Who may be eligible for this myopia clinical trial?

Children between 5 and 11 years old with myopia between 0.75 and 6.00 diopters in both eyes may be eligible. Participants must have worn single-vision spectacles regularly, have normal visual acuity for their age, and not have used prior myopia control treatments or contact lenses extensively. Please review eligibility criteria for more details.

Is there any cost to participate in this myopia clinical trial?

Study-related care, including the study eyedrops, spectacle lenses, and all trial visits, is provided at no cost. However, personal travel expenses to attend visits may vary and are not guaranteed to be covered. Participants can expect regular clinic visits for assessments throughout the study.

Actively Recruiting

Phase 3

Age: 5Years - 11Years

All Genders

ID07095894

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

Research Sites

26 weeks

Total Duration

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

Age: 5Years - 11Years

All Genders

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

Research Team

Raymond T Kraker, MSPH

Courtney L Conner

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