Myopia
Conditions
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.
Interventions
DEVICECXL 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.
Sponsors
Glaukos Corporation
University Hospital, Toulouse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Best corrected visual acuity | 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 1 month | Clinical examination and slit lamp biomicroscopy |
| Uncorrected visual acuity | 3 months | — |
| Mean change in manifest refraction spherical equivalent from baseline | 3 months | — |
| Mean change in corneal curvature from baseline | 3 months | — |
Countries
France
Outcome results
None listed