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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by University Hospital, Toulouse
Sponsor:
Collaborator:
Avedro, Inc.
Information provided by (Responsible Party):
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT02872766
First received: August 16, 2016
Last updated: NA
Last verified: August 2016
History: No changes posted
  Purpose

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 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 Intervention Phase
Myopia
Device: CXL Myopie
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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.

Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 43
Study Start Date: January 2016
Estimated Study Completion Date: January 2020
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Myopie
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.

  Eligibility

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

Inclusion Criteria:

  • Provide written informed consent
  • Willingness to folow 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 cylindral 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02872766

Contacts
Contact: Amandine HUGUET 561778490 ext +33 huguet.a@chu-toulouse.fr
Contact: Marie-Elise Llau 561778771 ext +33

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.
  More Information

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT02872766     History of Changes
Other Study ID Numbers: 15 7714 03
Study First Received: August 16, 2016
Last Updated: August 16, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Myopia
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 25, 2017