NCT06523504

Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control

Efficacy and Safety of Low-concentration Atropine Eye Drops (0.02%, 0.04%) Combined With Defocus Incorporated Multiple Segments (DIMS) for Moderate and High Myopia Control

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 410 (estimated)
• Sponsor: Ruihua Wei · Academic / Other
• Sex: All
• Age: 6 Years – 12 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the effectiveness and safety of DIMS, low concentration atropine eye drops,and atropine combined with DIMS in controlling axial length and refraction in children with moderate to high myopia.

Detailed description

In this study, stratified block randomization was employed for random grouping, and the total sample size required as calculated was 410 individuals. Firstly, 410 subjects were assigned ID numbers ranging from 1 to 410. SPSS.26 statistical software was utilized to apply the "random number generator" by setting the "fixed seed number" to "20231121", and subsequently generate random numbers. Once the random numbers were obtained, random sampling and grouping were conducted. This study was a multicenter trial, with block randomization stratified by center. The total sample size of 410 was distributed across 4 cities, and the samples collected in each city were randomly allocated into 5 treatment groups (groups A, B, C, D, and E), with approximately 20 individuals in each group.

Conditions

• Myopia

Interventions

Type	Name	Description
DEVICE	DIMS	wear DIMS ,and use placebo,once nightly, both eye
DRUG	The 0.02% ATP Group	wear SP, and use 0.02%ATP eye drops, once nightly, both eye
DRUG	The 0.04% ATP Group	wear SP, and use 0.04%ATP eye drops, once nightly, both eye
COMBINATION_PRODUCT	0.02%ATP+DIMS	wear DIMS, and use 0.02%ATP eye drops, once nightly, both eye
COMBINATION_PRODUCT	0.04%ATP+DIMS	wear DIMS, and use 0.04%ATP eye drops, once nightly, both eye

Timeline

• Start date: 2024-02-01
• Primary completion: 2026-03-31
• Completion: 2026-03-31
• First posted: 2024-07-26
• Last updated: 2025-09-08

Locations

1 site across 1 country: China