Evaluation of the Safety and Efficacy of Corneal Cross Linking for the Treatment of Myopia. (CXLMyopie)
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ClinicalTrials.gov Identifier: NCT02872766 |
Recruitment Status :
Terminated
(lack of efficacy)
First Posted : August 19, 2016
Last Update Posted : October 1, 2019
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Myopia | Device: CXL Myopia | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 24 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Pilot Evaluation of the Safety and Efficacy of Topographically Customized Corneal Cross Linking for the Treatment of Myopia. |
Study Start Date : | January 2016 |
Actual Primary Completion Date : | January 2018 |
Actual Study Completion Date : | January 2018 |

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.
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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. |
- Best corrected visual acuity [ Time Frame: 1 month ]
- Best corrected visual acuity [ Time Frame: 3 months ]
- Best corrected visual acuity [ Time Frame: 6 months ]
- Best corrected visual acuity [ Time Frame: 12 months ]
- Best corrected visual acuity [ Time Frame: 24 months ]
- Adverse events [ Time Frame: 1 month ]Clinical examination and slit lamp biomicroscopy
- Adverse events [ Time Frame: 3 months ]Clinical examination and slit lamp biomicroscopy
- Adverse events [ Time Frame: 6 months ]Clinical examination and slit lamp biomicroscopy
- Adverse events [ Time Frame: 12 months ]Clinical examination and slit lamp biomicroscopy
- Adverse events [ Time Frame: 24 months ]Clinical examination and slit lamp biomicroscopy
- Uncorrected visual acuity [ Time Frame: 3 months ]
- Mean change in manifest refraction spherical equivalent from baseline [ Time Frame: 3 months ]
- Mean change in corneal curvature from baseline [ Time Frame: 3 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872766
France | |
Toulouse University Hospital | |
Toulouse, France |
Principal Investigator: | François MALECAZE, MD | University Hospital, Toulouse |
Responsible Party: | University Hospital, Toulouse |
ClinicalTrials.gov Identifier: | NCT02872766 |
Other Study ID Numbers: |
15 7714 03 |
First Posted: | August 19, 2016 Key Record Dates |
Last Update Posted: | October 1, 2019 |
Last Verified: | September 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Myopia Refractive Errors Eye Diseases |