Using 0.01% atropine to treat near work-induced myopia in children
a Parallel Assignment Prospective, Randomized, Double-blinded, Placebo-controlled Trial to Evaluate the Efficacy of 0.01% Atropine for Near Work-induced Transient Myopia and Myopic Progression
This study is testing if 0.01% atropine eye drops can help children aged 6 to 12 with temporary blurry vision from close-up work and slow down the worsening of their nearsightedness.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 6 Years to 12 Years |
| Sex | All |
| Sponsor | He Eye Hospital Academic / other |
| Locations | 2 sites (Shenyang, Liaoning and 1 other locations) |
| Trial ID | NCT06034366 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of 0.01% atropine eye drops in reducing near work-induced transient myopia (NITM) and slowing myopic progression in children aged 6 to 12 years. Participants will be randomly assigned to receive either the atropine treatment or a placebo once nightly for one year. Key measurements will include cycloplegic refraction, axial length, best-corrected visual acuity, intraocular pressure, and pupil diameter at various intervals throughout the study. The trial aims to assess both the short-term and long-term effects of atropine on myopia development in a pediatric population.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 to 12 years with specific myopic conditions and good visual acuity.
Not a fit: Patients with existing ocular diseases or systemic conditions that may interfere with the treatment are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the progression of myopia in children, potentially improving their long-term vision health.
How similar studies have performed: Previous studies have shown that atropine can effectively reduce myopic progression, suggesting a promising avenue for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 6 to 12 years * Subjects and their guardians agreed to participate in this study * Best-corrected visual acuity (BCVA) 0.1 (log minimum angle of resolution, LogMAR) or better. * Initial NITM (spherical equivalent) ≤ -0.25 D * Cycloplegic refractions ≥ -1.0 D and astigmatism ≤ 2.5 D in both eyes. * Anisometropia in both eyes ≤ 1.5 D Exclusion Criteria: * Children with existing systemic diseases including asthma, collagen disease, immune system disorders, prostate hypertrophy, spastic paralysis, Down's syndrome, severe cardiac, pulmonary, hepatic, and renal dysfunction. * Patients with glaucoma or high intraocular pressure, ocular inflammatory diseases, strabismus, amblyopia, corneal diseases, diseases of lens, retinal and optic neuropathy * Regular use of medications that may affect the efficacy of 0.01% atropine, including hairy fruit rutabaga eye drops, tropicamide eye drops, anticholinergic drugs such as pirenzepine and tropicamide, and cholinergic drugs such as carbachol and hairy fruit rutabaga. * Previous experiences with myopia control therapy. * A history of allergies to atropine. * Patients were deemed inappropriate for trial participation by the lead investigator.
Where this trial is running
Shenyang, Liaoning and 1 other locations
- He Eye Hospital — Shenyang, Liaoning, China (Recruiting)
- He Eye Specialist Hospital — Shenyang, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.