Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523504
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Atropine 002 004 Combined With Defocus DIMS for Moderate and High Myopia Control
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Efficacy and Safety of Low-concentration Atropine Eye Drops 002 004 Combined With Defocus Incorporated Multiple Segments DIMS for Moderate and High Myopia Control
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 dropsand 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 SPSS26 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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None