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

Toulouse University Hospital

Status: Terminated

Conditions: Myopia

Treatments: Device: CXL Myopia

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02872766

15 7714 03

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

24 participants in 1 patient group

Corneal cross linking (CXL)

Experimental group

Description:

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.

Treatment:

Device: CXL Myopia