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

NCT ID: NCT02872766

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-01-31

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.

Conditions

Myopia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

CXL Myopia

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Glaukos Corporation

INDUSTRY

Sponsor Role: collaborator

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

François MALECAZE, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Toulouse University Hospital

Toulouse, , France

Countries

France

Other Identifiers

15 7714 03

Identifier Type: -

Identifier Source: org_study_id