Evaluating the Safety and Efficacy of the KXL System for Corneal Collagen Cross-Linking in Eyes Having Keratoconus

This is an interventional treatment trial for Keratoconus focused on measuring Keraroconus, keratectasia, treatment Read More

Inclusion Criteria:

1. Age Limit for for keratoconus and Plec:18 years
2. Sign the informed consent.
3. Willingness and ability to follow all instructions and comply with schedule for follow-up visits;

4. Contact Lens Wearers Only:

   Minimum of 3 days

5. For KC subjects:

   1. Axial topography consistent with keratoconus(Pentacam )
   2. Presence of central or inferior steepening on the Pentacam map;
   3. Steepest keratometry (Kmax) value ≥ 47.00 D;
   4. May have corneal scarring up to and including CLEK grade 4.0 (any scarring up to a dense/opaque stromal scar consistent with KC)
   5. Keratoconus progressing over time ( evidenced by topography changes, visual acuity or refractive changes)

6. For PLEc subjects:

   1. Having a diagnosis of corneal ectasia after corneal refractive surgery (e.g., LASIK, PRK, epi-LASIK,LASEK,)
   2. Presence of central or inferior steepening on the Pentacam map.
   3. Axial topography consistent with corneal ectasia

Exclusion Criteria:

1. Contraindications, sensitivity or known allergy to the use of the test article(s) or their components;
2. If female, be pregnant, nursing or planning a pregnancy or have a positive urine pregnancy test at Visit 2 prior to randomization or during the course of the study;
3. For KC and PLEc subjects, corneal pachymetry that is < 400microns prior to epithelial debridement at the thinnest point measured by Pentacam in the eye to be treated;
4. A history of chemical injury or delayed epithelial healing in the eye(s) to be treated;
5. Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests;
6. Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing;
7. Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment,retinoic acid within 6 months of treatment

8. Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example:

   8.1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.); 8.2. Clinically significant corneal scarring in the cross-linking treatment zone or in the investigator's opinion, will interfere with the cross-linking procedure;

9. For KC subjects 9.1. Eyes which are aphakic; 9.2. Eyes that have the maximum corneal curvature (Kmax), as identified and measured by Pentacam, outside of the central 5mm zone; Note: In addition, the Investigator may exclude or discontinue any subject for any sound medical reason.