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

This study is currently recruiting participants.

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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 (IPD) Sharing Statement:
Plan to Share IPD:	No

Additional relevant MeSH terms:


Myopia Refractive Errors Eye Diseases

ClinicalTrials.gov processed this record on July 19, 2017

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