Treating Corneal Thinning Conditions With CCL Vario Riboflavin (CXL)
Treating Corneal Thinning Conditions With CCL Vario Riboflavin (CXL)
Study is testing the efficacy of treating corneal thinning conditions with Vitamin B2
 (Riboflavin) and the application on UV Light.
Corneal thinning conditions, i.e. keratoconus or ectasia, weaken the cornea which then causes
 the front of the eye to bulge out. This results in distorted vision and could eventually
 result in the need for a cornea transplant. This study proposes to conclude that saturating
 the cornea with vitamin B2 (Riboflavin) and then applying 365nm wavelength of Ultra Violet
 Light will result in the various layers of corneal tissue linking together. This cross
 linking results in a stronger cornea which is designed to halt the progression of keratoconus
 or ectasia. This treatment is already being successfully used in Europe.
Inclusion Criteria:

 -  Presence of central or inferior corneal steepening

 -  Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid
 marginal degeneration

 -  Presence of one or more findings associated with keratoconus or pellucid marginal
 degeneration, such as:

 -  Fleischer ring

 -  Vogt's striae

 -  Decentered corneal apex

 -  Munson's sign

 -  Rizutti's sign

 -  Apical corneal scarring consistent with Bowman's breaks

 -  Scissoring of the retinoscopic reflex

 -  Crab-claw appearance on topography

 -  Steepest keratometry (Kmax) value > or = 47.20 D

 -  I-S keratometry difference > 1.5 D on the Orbscan map

 -  Posterior corneal elevation > 16 microns

 -  Thinnest corneal point < 485 microns

 -  Post LASIK/PRK stromal ablation depth < 300 microns or expected keratometry > 47.2 D,
 or post-PRK/SMILE in keratoconus suspect eyes

 -  Bacterial or fungal corneal keratitis persistent and not responding despite > 2 weeks
 of standard antimicrobial therapy or with rapid progression of corneal thinning, with
 loss of > 25% corneal thickness

 -  Contact Lens Wearers Only:

 -  Removal of contact lenses for the required period of time prior to the screening
 refraction:

 Contact Lens Type Minimum Discontinuation Time Soft 1 Week Soft Extended Wear 2 Weeks Soft
 Toric 3 Weeks Rigid Gas Permeable 2 Weeks per decade of wear

 -  Signed written informed consent

 -  Willingness and ability to comply with schedule for follow-up visits

 Exclusion Criteria:

 -  Eyes classified as either normal or atypical normal on the severity grading scheme

 -  Corneal pachymetry at the screening exam that is < 400 microns at the thinnest point
 in the eye(s) to be treated when the transepithelial (isotonic) riboflavin solution
 alone will be used or < 300 microns when the hypotonic riboflavin will be used.

 -  Previous ocular condition (other than refractive error) in the eye(s) to be treated
 that may predispose the eye for future complications, for example:

 1. History of or active corneal disease (e.g., herpes simplex, herpes zoster
 keratitis, recurrent erosion syndrome, acanthamoeba, etc.)

 2. Clinically significant corneal scarring in the CXL treatment zone that is not
 related to keratoconus or, in the investigator's opinion, will interfere with the
 cross linking procedure

 -  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 physician's opinion, would interfere
 with or prolong epithelial healing