Overview
To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.
Description
Patients with progressive keratoconus, pellucid marginal degeneration, 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, pachymetry, and visual function questionnaire.
Eligibility
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:
1.10 years of age or older 2. Presence of central or inferior steepening 3. Axial
topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal
degeneration 4. Presence of one or more findings associated with keratoconus or pellucid
marginal degeneration, such as:
1. Fleischer ring
2. Vogt's striae
3. Decentered corneal apex
4. Munson's sign
5. Apical Corneal scarring consistent with Bowman's breaks
6. Scissoring of the retinoscopic reflex
7. Crab-claw appearance on topography 5. Steepest keratometry (Kmax) value ≥ 47.20 D 6.
I-S keratometry difference > 1.5 D on the Pentacam map or topography map 7. Posterior
corneal elevation >16 microns 8. Thinnest corneal point >300 microns 9. 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 or Scleral 3 days Rigid gas
permeable 2 weeks
Exclusion Criteria:
All subjects meeting any of the following criteria will be excluded from this study:
1. Eyes classified as either normal or atypical normal on the severity grading scheme.
2. Corneal pachymetry at the screening exam that is <300 microns at the thinnest point in
the eye(s) to be treated.
3. 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, acanthomeoeba, 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.
4. Pregnancy (including plan to become pregnant) or lactation during the course of the
study
5. A known sensitivity to study medications
6. Patients with nystagmus or any other condition that would prevent a steady gaze during
the CXL treatment or other diagnostic tests.
7. Patients with a current condition that, in the physician's opinion, would interfere
with or prolong epithelial healing.