Safety and Effectiveness of the PXL -Platinum 330 System for Cornea Collagen Crosslinking in Eyes With Corneal Thinning Conditions
Cohen Laser and Vision Center
Summary
This study study is to determine the effectiveness of cornea cross linking in patients with Keratoconus or other cornea thinning conditions.
Description
This study is an investigator initiated single center study that will be conducted over 10 years. Up to 300 patients with cornea thinning conditions will be enrolled. This is a prospective, single-arm, nonrandomized single site study to determine the safety and effectiveness of the PXL Platinum 330 system for performing collagen cross linking (CXL) in eyes with cornea thinning. Subjects with a history of keratoconus, pellucid marginal degeneration, thin corneas undergoing LASIK, PRK or INTACS will be evaluated for suitability as a candidate for CXL. Subjects that are candidates for CXL will be…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * healthy subjects with no other medical or ocular conditions 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: * 18 years of age or older * Presence of central or inferior steepening (on Pentacam topograph) * Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration (See keratoconus grading section 7.0 for details) * Presence of one or more findings associated with keratoconus or pellucid marginal degeneration on slit lamp exam such as…
Interventions
- DevicePXL Platinum 330 system
to determine the efficacy of riboflavin solution and UV light to treat cornea thinning conditions
Location
- Cohen Laser and Vision CenterBoca Raton, Florida