Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-27 @ 7:58 PM
Study NCT ID:
NCT05533450
Status:
UNKNOWN
Last Update Posted:
2022-10-19
First Post:
2022-09-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on the Efficacy and Safety of Multi-focal Scleral Contact Lens
Sponsor:
Shanghai Eye Disease Prevention and Treatment Center
Organization:
Study Overview
Official Title:
A Multicenter Randomized Controlled Study on the Efficacy and Safety of Multi-focal Scleral Contact Lens in the Treatment of Ultra-high Myopia in Children and Adolescents
Status:
UNKNOWN
Status Verified Date:
2022-10
Last Known Status:
NOT_YET_RECRUITING
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:
None
Brief Summary:
The rigid scleral contact lens with optical multi-focal design adopted in this study can focus the light in part of the optical area on the front of the retina to form myopic defocus, in order to delay the axial changes in children and adolescents with ultra-high myopia. In this study, RGP was used as a control, and a multicenter, randomized, controlled trial was conducted to verify the safety and effectiveness of multifocal scleral contact lenses for the correction of ultra-high myopia in children and adolescents.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: