the Efficacy of 0.01% Atropine for Near Work-induced Transient Myopia and Myopic Progression

• Status: Recruiting
• Trial end date: 2025-05-31
• Target enrollment: 0
• Participant gender: All

Summary

Near work-induced transient myopia (NITM) is an important factor in permanent myopia (PM) development and progression. Atropine eye drop is beneficial in reducing initial NITM and slowing down myopic progression.Participants were randomly assigned in a 1:1 ratio to receive 0.01% atropine or placebo eye drop once nightly bilaterally for one year. Initial NITM, cycloplegic refraction, axial length (AL), best-corrected visual acuity (BCVA), intraocular pressure (IOP), and pupil diameter will be measured at baseline, 4-week, 12-week, 24-week, 36-week, and 48-week. Visual Function Questionnaire was administered at baseline and each follow-up visit. Adverse events also will be monitored and documented at each subsequent follow-up visit. This study investigates the efficacy of 0.01% atropine in the treatment of NITM and its possible association with the progression of refractive change in Chinese myopic children.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: He Eye Hospital
• Treatments: Atropine

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.