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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02872766
• Date of registration: 16/08/2016
• Prospective Registration: No
• Primary sponsor: University Hospital, Toulouse
• Public title: Evaluation of the Safety and Efficacy of Corneal Cross Linking for the Treatment of Myopia. CXLMyopie
• Scientific title: A Pilot Evaluation of the Safety and Efficacy of Topographically Customized Corneal Cross Linking for the Treatment of Myopia.
• Date of first enrolment: January 2016
• Target sample size: 24
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02872766
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

France

Contacts

• Name: François MALECAZE, MD
• Affiliation: University Hospital, Toulouse

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Myopia

Intervention(s)

Device: CXL Myopia

Primary Outcome(s)

Best corrected visual acuity [Time Frame: 1 month]

Best corrected visual acuity [Time Frame: 12 months]

Best corrected visual acuity [Time Frame: 24 months]

Best corrected visual acuity [Time Frame: 3 months]

Best corrected visual acuity [Time Frame: 6 months]

Secondary Outcome(s)

Adverse events [Time Frame: 24 months]

Adverse events [Time Frame: 3 months]

Adverse events [Time Frame: 6 months]

Adverse events [Time Frame: 1 month]

Adverse events [Time Frame: 12 months]

Mean change in corneal curvature from baseline [Time Frame: 3 months]

Mean change in manifest refraction spherical equivalent from baseline [Time Frame: 3 months]

Uncorrected visual acuity [Time Frame: 3 months]

Secondary ID(s)

15 7714 03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Avedro, Inc.