Ignite Creation Date:
2025-12-24 @ 9:09 PM
Ignite Modification Date:
2026-01-02 @ 9:27 AM
Study NCT ID:
NCT06523504
Status:
RECRUITING
Last Update Posted:
2025-09-08
First Post:
2024-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Atropine (0.02%, 0.04%) Combined With Defocus DIMS for Moderate and High Myopia Control
Sponsor:
Ruihua Wei
Organization:
Study Overview
Official Title:
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
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
atropine
Brief 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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2019yj001J-5 | OTHER_GRANT | Beijing Bethune Charitable Foundation | View |