Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Riboflavin/Dextran or Riboflavin/Methylcellulose
Sponsored by Cornea and Laser Eye Institute
About this trial
Last updated 2 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Started 4 years ago
What is this trial about?
What are the participation requirements?
Inclusion Criteria
- 12 years of age or older
- Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery
- Presence of central or inferior steepening on the Pentacam map
- Axial topography consistent with keratoconus or post-surgical corneal ectasia
- Contact lens wearers only: removal of contact lens for the required period of 1 week prior to the screening refraction
- Signed written informed consent
- Willingness and ability to comply with schedule for follow-up visits
Exclusion Criteria
- Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme
- Corneal pachymetry less than or equal to 300 microns at the thinnest point measured by Pentacam in the eye(s) to be treated
- Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example: History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) Clinically significant corneal scarring in the CXL treatment zone
- A history of chemical injury or delayed epithelial healing in the eye(s) to be treated
- Pregnancy (including plan to become pregnant) or lactation during the course of the study
- A known sensitivity to study medications
- Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests
- Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing