Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-01-01 @ 7:55 AM
Study NCT ID:
NCT04275635
Status:
UNKNOWN
Last Update Posted:
2020-03-16
First Post:
2020-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Validation of a Predictive Algorithm to Determine the Effectiveness of Orthokeratology for Myopia Control
Sponsor:
Sun Yat-sen University
Organization:
Study Overview
Official Title:
Validation of a Predictive Algorithm to Determine the Effectiveness of Orthokeratology for Myopia Control
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
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:
This is a prospective study to validate a predictive algorithm for identifying fast progressing myopes.
Detailed Description:
Orthokeratology (ortho-K) has been demonstrated to slow myopic progression and reduce axial elongation in young patients, but this treatment is limited by the need for contact lens wear, which is the common cause for keratitis in children, and therefore cautious use is recommended. There is a need to identify the patients that could benefit most from this treatment. In order to do so, we conduct a retrospective study and create a large database (n = 10,000) of de-identified data to train an algorithm for identifying fast progressing myopes. In addition, we will perform a prospective study to validate this predictive algorithm and determine the effectiveness of Orthokeratology among different individual patients in China.
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?:
None
Is an FDA AA801 Violation?: