safety and effectiveness of the pxl-platinum 330 system for corneal cross-linking

Conditions: Keratoconus, Unstable; Bacterial Keratitis; Ectasia of Cornea

Summary: to determine whether the peschke pxl-330 system is safe and effective in the treatment of corneal thinning conditions.

patients with progressive keratoconus, pellucid marginal degeneration, infectious keratitis, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the peschke pxl-330 system using pulsed, accelerated energy delivery. patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, intraocular pressure, and visual function questionnaire.

Eligibility criteria:
inclusion criteria: subjects who have one or both eyes that meet criteria 1 \& 2 and 1 or more of the following criteria will be considered candidates for this study. * 12 years of age or older * evidence of progressive keratoconus (based on the discretion of the physician as evidenced by an increase in astigmatism, asymmetry, or worsening vision in the last 3 or more months) * presence of central or inferior steepening. * axial topography consistent with keratoconus * presence of one or more findings associated with keratoconus 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 * avagen (avellino labs) genetic testing keratoconus risk score of 67 or higher (high risk). * signed written informed consent * willingness and ability to comply with schedule for follow-up visits * for 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 * scleral lenses * 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): * eyes classified as either normal or atypical normal on the severity grading scheme. * corneal pachymetry at the screening exam that is \<330 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 active medical implants (e.g. cardiac pacemakers)' * patients who are aphakic/ pseudophakic