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

Primary Purpose

Myopia

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
CXL Myopia
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Myopia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Toulouse University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Corneal cross linking (CXL)

Arm Description

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.

Outcomes

Primary Outcome Measures

Best corrected visual acuity
Best corrected visual acuity
Best corrected visual acuity
Best corrected visual acuity
Best corrected visual acuity

Secondary Outcome Measures

Adverse events
Clinical examination and slit lamp biomicroscopy
Adverse events
Clinical examination and slit lamp biomicroscopy
Adverse events
Clinical examination and slit lamp biomicroscopy
Adverse events
Clinical examination and slit lamp biomicroscopy
Adverse events
Clinical examination and slit lamp biomicroscopy
Uncorrected visual acuity
Mean change in manifest refraction spherical equivalent from baseline
Mean change in corneal curvature from baseline

Full Information

First Posted
August 16, 2016
Last Updated
September 27, 2019
Sponsor
University Hospital, Toulouse
Collaborators
Glaukos Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02872766
Brief Title
Evaluation of the Safety and Efficacy of Corneal Cross Linking for the Treatment of Myopia.
Acronym
CXLMyopie
Official Title
A Pilot Evaluation of the Safety and Efficacy of Topographically Customized Corneal Cross Linking for the Treatment of Myopia.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Terminated
Why Stopped
lack of efficacy
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse
Collaborators
Glaukos Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myopia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Corneal cross linking (CXL)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
CXL Myopia
Intervention Description
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.
Primary Outcome Measure Information:
Title
Best corrected visual acuity
Time Frame
1 month
Title
Best corrected visual acuity
Time Frame
3 months
Title
Best corrected visual acuity
Time Frame
6 months
Title
Best corrected visual acuity
Time Frame
12 months
Title
Best corrected visual acuity
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Adverse events
Description
Clinical examination and slit lamp biomicroscopy
Time Frame
1 month
Title
Adverse events
Description
Clinical examination and slit lamp biomicroscopy
Time Frame
3 months
Title
Adverse events
Description
Clinical examination and slit lamp biomicroscopy
Time Frame
6 months
Title
Adverse events
Description
Clinical examination and slit lamp biomicroscopy
Time Frame
12 months
Title
Adverse events
Description
Clinical examination and slit lamp biomicroscopy
Time Frame
24 months
Title
Uncorrected visual acuity
Time Frame
3 months
Title
Mean change in manifest refraction spherical equivalent from baseline
Time Frame
3 months
Title
Mean change in corneal curvature from baseline
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François MALECAZE, MD
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toulouse University Hospital
City
Toulouse
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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