Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06431841
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-03-13
Brief Title:
Atropine and Spectacle Combination Treatment ASPECT 12-month Results of a Randomized Clinical Trial for Myopia Control
Sponsor:
Hospital San Carlos Madrid
Organization:
Hospital San Carlos Madrid
Study Overview
Official Title:
Postmarketing Parallel Randomized Clinical Trial to Determine the Efficacy and Safety of Atropine and DIMS Lenses in the Control of Myopia in a Pediatric Population
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
ASPECT
Brief Summary:
Phase IV clinical trial to evaluate whether there is a significant difference in the control of myopia progression in myopic children treated with 0025 atropine and DIMS spectacle lenses compared to 0025 atropine and single vision SV lenses Open-label randomized parallel clinical trial involving 50 subjects in each treatment arm 100 patients in total The primary efficacy endpoint will be the change in cycloplegic spherical equivalent refraction SER and axial length AL compared to baseline values
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None