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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 : Recruiting
First Posted : August 19, 2016
Last Update Posted : November 1, 2017
Sponsor:
Collaborator:
Avedro, Inc.
Information provided by (Responsible Party):
University Hospital, Toulouse

Study Description
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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.


Condition or disease Intervention/treatment Phase
Myopia Device: CXL Myopia Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
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
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : January 2020

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Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Best corrected visual acuity [ Time Frame: 1 month ]
  2. Best corrected visual acuity [ Time Frame: 3 months ]
  3. Best corrected visual acuity [ Time Frame: 6 months ]
  4. Best corrected visual acuity [ Time Frame: 12 months ]
  5. Best corrected visual acuity [ Time Frame: 24 months ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: 1 month ]
    Clinical examination and slit lamp biomicroscopy

  2. Adverse events [ Time Frame: 3 months ]
    Clinical examination and slit lamp biomicroscopy

  3. Adverse events [ Time Frame: 6 months ]
    Clinical examination and slit lamp biomicroscopy

  4. Adverse events [ Time Frame: 12 months ]
    Clinical examination and slit lamp biomicroscopy

  5. Adverse events [ Time Frame: 24 months ]
    Clinical examination and slit lamp biomicroscopy

  6. Uncorrected visual acuity [ Time Frame: 3 months ]
  7. Mean change in manifest refraction spherical equivalent from baseline [ Time Frame: 3 months ]
  8. Mean change in corneal curvature from baseline [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
Contact: Laura BOGDANOVITCH 561778437 ext +33 bogdanovitch.l@chu-toulouse.fr

Locations
France
Toulouse University Hospital Recruiting
Toulouse, France
Contact: François MALECAZE, Pr    561779999 ext +33    malecaze.f@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Avedro, Inc.
Investigators
Principal Investigator: François MALECAZE, MD University Hospital, Toulouse
More Information
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Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02872766     History of Changes
Other Study ID Numbers: 15 7714 03
First Posted: August 19, 2016    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases