Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06411717
Status:
RECRUITING
Last Update Posted:
2024-05-14
First Post:
2024-05-08
Brief Title:
A Clinical Trial to Evaluate the Efficacy and Safety of Defocusing Lenses in Delaying Myopia Progression
Sponsor:
Suzhou Kerui Medical Technology Co Ltd
Organization:
Suzhou Kerui Medical Technology Co Ltd
Study Overview
Official Title:
A Prospective Single-center Randomized Double-blind Controlled Optimal Clinical Study to Evaluate the Efficacy and Safety of Defocusing Lenses in Delaying Myopia Progression
Status:
RECRUITING
Status Verified Date:
2024-05
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:
None
Brief Summary:
The objective of this clinical trial was to evaluate the efficacy and safety of defocusing lenses for delaying myopia progression in children and adolescents A total of 156 subjects meeting the requirements of the study protocol were included During the study subjects were required to wear the test product defocus lens A or defocus lens B or the control product aspheric lens for 12 months and regular follow-up was required during the wearing process including various ophthalmological examinations and subjective feelings about wearing the lens During the study period the product status ocular conditions adverse events and serious adverse events were continuously observed to evaluate the safety and effectiveness of the test product in clinical use
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