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

Study Overview
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Brief Summary
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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.

Official Title
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A Pilot Evaluation of the Safety and Efficacy of Topographically Customized Corneal Cross Linking for the Treatment of Myopia.

Conditions
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Myopia

Intervention / Treatment
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* Device: CXL Myopia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Corneal cross linking (CXL)<br>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 Myopia<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best corrected visual acuity |  | 1 month | 
| Best corrected visual acuity |  | 3 months | 
| Best corrected visual acuity |  | 6 months | 
| Best corrected visual acuity |  | 12 months | 
| Best corrected visual acuity |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events | Clinical examination and slit lamp biomicroscopy | 1 month | 
| Adverse events | Clinical examination and slit lamp biomicroscopy | 3 months | 
| Adverse events | Clinical examination and slit lamp biomicroscopy | 6 months | 
| Adverse events | Clinical examination and slit lamp biomicroscopy | 12 months | 
| Adverse events | Clinical examination and slit lamp biomicroscopy | 24 months | 
| 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 |