Clinical Trial

Low Concentration Atropine Combined With Soft Contact Lens in Controlling Myopia Progression in Children With High Myopia

Completed Phase 4
View on ClinicalTrials.gov →
Summary
Peripheral contact lens in controlling myopia progression in high myopia children(PAM)is a prospective, single-center, randomized controlled trial with three parallel arms conducted at Beijing Tongren Hospital. Chinese children aged 6-12 years with high myopia (spherical equivalent ≤-6.0D) and annual progression ≥0.75D will be enrolled. Participants will be randomized 40:40:40 to: (1) combination therapy group receiving atropine 0.04% plus soft peripheral defocus contact lenses; (2) atropine monotherapy group receiving atropine 0.04% plus spectacles; or (3) control group receiving atropine 0.01% plus spectacles. The primary outcome is change in axial length and cycloplegic refraction at 24 months. Secondary outcomes include changes in pupil diameter, and safety parameters.
Trial Details
NCT Number NCT07406399
Lead Sponsor Beijing Tongren Hospital
Conditions High Myopia, Low Concentration Atropine, Soft Contact Lens, Children
Enrollment 120 participants
Start Date 2023-06-30
Primary Completion 2025-11-30 (estimated)
Study Completion 2026-01-30 (estimated)
Updated on ClinicalTrials.gov 2026-02-12