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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 : Terminated (lack of efficacy)
First Posted : August 19, 2016
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Glaukos Corporation
Information provided by (Responsible Party):
University Hospital, Toulouse

Tracking Information
First Submitted Date  ICMJE August 16, 2016
First Posted Date  ICMJE August 19, 2016
Last Update Posted Date October 1, 2019
Study Start Date  ICMJE January 2016
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 16, 2016)
  • 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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 31, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: August 16, 2016)
  • Advers events [ Time Frame: 1 month ]
  • Advers events [ Time Frame: 3 months ]
  • Advers events [ Time Frame: 6 months ]
  • Advers events [ Time Frame: 12 months ]
  • Advers events [ Time Frame: 24 months ]
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Safety and Efficacy of Corneal Cross Linking for the Treatment of Myopia.
Official Title  ICMJE A Pilot Evaluation of the Safety and Efficacy of Topographically Customized Corneal Cross Linking for the Treatment of Myopia.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Myopia
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: CXL Myopia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 20, 2018)
24
Original Estimated Enrollment  ICMJE
 (submitted: August 16, 2016)
43
Actual Study Completion Date  ICMJE January 2018
Actual Primary Completion Date January 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02872766
Other Study ID Numbers  ICMJE 15 7714 03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Hospital, Toulouse
Study Sponsor  ICMJE University Hospital, Toulouse
Collaborators  ICMJE Glaukos Corporation
Investigators  ICMJE
Principal Investigator: François MALECAZE, MD University Hospital, Toulouse
PRS Account University Hospital, Toulouse
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP