Safety and Effectiveness Study of the VEGA UV-A System for Cross-linking in Eyes With Keratoconus and Ectasia

Long Term Safety and Effectiveness of the VEGA UV-A System for Corneal Collagen Cross-Linking in Eyes With Keratoconus or Post-Refractive Corneal Ectasia

The purpose of this research study is to evaluate the long tern safety and effectiveness of cross-linking in eyes with keratoconus and ectasia.

Inclusion Criteria:

• 12 years of age or older
• Diagnosis of Keratoconus or Ectasia
• Central or Inferior steepening on the Pentacam map
• Topography consistent with Keratoconus or Ectasia
• BSCVA 20/20 or worse
• Removal of contact lenses for required period of time
• Signed written informed consent
• Willingness and ability to comply with schedule for follow up visits

Exclusion Criteria

• For Keratoconus, a history of previous corneal surgery
• Corneal pachymentry equal to or greater and 400
• Previous ocular condition in the eyes to be treated that may predispose the eye for future complications
• A history of chemical injury or delayed healing
• Pregnancy
• A known sensitivity to the study medications
• Nystagmus or any other condition that would prevent a steady gaze during treatment or other diagnostic tests
• Presence or history of any other condition or finding that makes the patient unsuitable as a candidate