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

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

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.

Study Overview

• Status: Terminated
• Conditions: Myopia
• Intervention / Treatment: Device: CXL Myopia

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Toulouse, France
    • Toulouse University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Corneal cross linking (CXL); Applying riboflavin 0,22% to 0,25 % up to 20 minutes . Then, the eyes are exposed to Ultraviolet A light with the KXL II system according to the programmed treatment pattern.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Best corrected visual acuity	6 months
Best corrected visual acuity	24 months
Best corrected visual acuity	1 month
Best corrected visual acuity	3 months
Best corrected visual acuity	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	Clinical examination and slit lamp biomicroscopy	1 month
Adverse events	Clinical examination and slit lamp biomicroscopy	3 months
Adverse events	Clinical examination and slit lamp biomicroscopy	6 months
Adverse events	Clinical examination and slit lamp biomicroscopy	12 months
Adverse events	Clinical examination and slit lamp biomicroscopy	24 months
Uncorrected visual acuity		3 months
Mean change in manifest refraction spherical equivalent from baseline		3 months
Mean change in corneal curvature from baseline		3 months

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Collaborators: Glaukos Corporation
• Investigators: Principal Investigator: François Malecaze, MD, University Hospital, Toulouse

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): January 1, 2018
• Study Completion (Actual): January 1, 2018

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Actual): October 1, 2019
• Last Update Submitted That Met QC Criteria: September 27, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 15 7714 03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO