Evaluation of the Safety and Efficacy of Corneal Cross Linking for the Treatment of Myopia.

Myopia Clinical Trial

— CXLMyopie  

Official title:

A Pilot Evaluation of the Safety and Efficacy of Topographically Customized Corneal Cross Linking for the Treatment of Myopia.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02872766
• Other study ID #: 15 7714 03
• Status: Terminated
• Phase: N/A
• Start date: January 2016
• Est. completion date: January 2018

Study information

• Verified date: September 2019
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 24
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provide written informed consent

• Willingness to follow all instructions and comply with schedule for follow up visits

• Having myopia with manifest refraction spherical equivalent of -1.00 to -2.50 D, with cylindrical component pl to -0.75 D

• Social security insurance or equivalent

Exclusion Criteria:

• sensitivity to the use of the test article(s)

• hypersensitivity to local anesthesics

• Corneal pachymetry that is < 480 microns

• Eyes with keratoconus

• Eyes which are aphakic or with corneal intacs

• Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example: History of corneal disease (e.g., herpes simplex, recurrent erosion syndrome, corneal dystrophy, refractive keratotomy etc.), clinically significant corneal scarring in the crosslinking treatment zone

• Pregnancy or lactation

• Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing

• Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.

• Juridical protection

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• CXL Myopia
Applying riboflavin 0,22% to 0,25 % up to 20 minutes . Then, the eyes are exposed to UVA light with the KXL II system according to the programmed treatment pattern.

Locations

Country	Name	City	State
France	Toulouse University Hospital	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Toulouse	Avedro, Inc.

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity		1 month
Primary	Best corrected visual acuity		3 months
Primary	Best corrected visual acuity		6 months
Primary	Best corrected visual acuity		12 months
Primary	Best corrected visual acuity		24 months
Secondary	Adverse events	Clinical examination and slit lamp biomicroscopy	1 month
Secondary	Adverse events	Clinical examination and slit lamp biomicroscopy	3 months
Secondary	Adverse events	Clinical examination and slit lamp biomicroscopy	6 months
Secondary	Adverse events	Clinical examination and slit lamp biomicroscopy	12 months
Secondary	Adverse events	Clinical examination and slit lamp biomicroscopy	24 months
Secondary	Uncorrected visual acuity		3 months
Secondary	Mean change in manifest refraction spherical equivalent from baseline		3 months
Secondary	Mean change in corneal curvature from baseline		3 months