Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Subjects who have one or both eyes that meet criteria 1 and 1 or more of the following criteria will be considered candidates for this study:

12 years of age or older
Presence of central or inferior 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
Rizzutti's sign
Apical Corneal scarring consistent with Bowman's breaks
Scissoring of the retinoscopic reflex
Crab-claw appearance on topography
Steepest keratometry (Kmax) value ≥ 47.20 D
I-S keratometry difference > 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map
Posterior corneal elevation >16 microns
Thinnest corneal point <485 microns
Predicted Post LASIK/PRK stromal ablation depth <350 microns or expected keratometry >47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eyes
AvaGen (Avellino Labs) genetic testing keratoconus risk score of 67 or higher (high risk).
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:

a. 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 Scleral Lenses 2 Weeks per decade of wear Investigator Discretion

Discontinuation of scleral lenses not required unless there is clinical evidence of corneal hypoxia (e.g. corneal neovascularization) at time of screening.

Signed written informed consent
Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria (any of the following are reasons for exclusion):

1. All subjects meeting any of the following criteria will be excluded from this study:

Eyes classified as either normal or atypical normal on the severity grading scheme.
Corneal pachymetry at the screening exam that is <300 microns at the thinnest point 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 or active corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, acanthomeoeba, etc.)
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.