Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-02-02 @ 6:39 PM
Study NCT ID:
NCT02872766
Status:
TERMINATED
Last Update Posted:
2019-10-01
First Post:
2016-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Safety and Efficacy of Corneal Cross Linking for the Treatment of Myopia.
Sponsor:
University Hospital, Toulouse
Organization:
Study Overview
Official Title:
A Pilot Evaluation of the Safety and Efficacy of Topographically Customized Corneal Cross Linking for the Treatment of Myopia.
Status:
TERMINATED
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CXLMyopie
Brief Summary:
43 Subjects (43 eyes) qualified for participation will undergo the required screening procedures to determine study eligibility. The surgical protocol involves applying riboflavin 0,22% to 0,25 % up to 20 minutes . Then, the eyes will be exposed to UVA (ultraviolet A) light with the KXL II system according to the programmed treatment pattern.
All use of the KXL II system will be in accordance with the general instructions in the operator's manual. All subjects will be evaluated at screening, Day 3, and 1, 3, 6 ,12 and 24 months after treatment.
Manual keratometry, manifest refraction, uncorrected visual acuity, best corrected visual acuity, slit lamp biomicroscopy, pentacam measurements and placido disc topography (TMS), will be obtained at baseline and at appropriate times after the treatment.
All use of the KXL II system will be in accordance with the general instructions in the operator's manual. All subjects will be evaluated at screening, Day 3, and 1, 3, 6 ,12 and 24 months after treatment.
Manual keratometry, manifest refraction, uncorrected visual acuity, best corrected visual acuity, slit lamp biomicroscopy, pentacam measurements and placido disc topography (TMS), will be obtained at baseline and at appropriate times after the treatment.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?: