Clinical trial NCT02872766: Evaluation of the Safety and Efficacy of Corneal Cross Linking for the Treatment of Myopia.
Official title: A Pilot Evaluation of the Safety and Efficacy of Topographically Customized Corneal Cross Linking for the Treatment of Myopia.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Myopia
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
Collaborators: name: Glaukos Corporation
First posted: 2016-08-19
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Best corrected visual acuity
timeFrame: 1 month
measure: Best corrected visual acuity
timeFrame: 3 months
measure: Best corrected visual acuity
timeFrame: 6 months
measure: Best corrected visual acuity
timeFrame: 12 months
measure: Best corrected visual acuity
timeFrame: 24 months
Secondary outcomes:
measure: Adverse events
timeFrame: 1 month
measure: Adverse events
timeFrame: 3 months
measure: Adverse events
timeFrame: 6 months
measure: Adverse events
timeFrame: 12 months
measure: Adverse events
timeFrame: 24 months
measure: Uncorrected visual acuity
timeFrame: 3 months
measure: Mean change in manifest refraction spherical equivalent from baseline
timeFrame: 3 months
measure: Mean change in corneal curvature from baseline
timeFrame: 3 months
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse University Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: François MALECAZE, MD
role: PRINCIPAL_INVESTIGATOR
References: