RecruitingPhase 2NCT05516004

Safety and Effectiveness of the PXL-Platinum 330 System for Cornea Crosslinking in Eyes With Cornea Thinning

Safety and Effectiveness of the PXL -Platinum 330 System for Cornea Collagen Crosslinking in Eyes With Corneal Thinning Conditions

Sponsor

Cohen Laser and Vision Center

Enrollment

300 participants

Start Date

Jul 1, 2024

Study Type

INTERVENTIONAL

Conditions

Keratoconus

Summary

This study study is to determine the effectiveness of cornea cross linking in patients with Keratoconus or other cornea thinning conditions.

Eligibility

Min Age: 18 Years

Inclusion Criteria25

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:
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:
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 on simK or Pentacam
I-S keratometry difference > 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map
Posterior corneal elevation >16 microns (µm on Pentacam tomography)
Thinnest corneal point <485 microns (ultrasound pachymetry or Pentacam tomography)
Predicted Post LASIK/PRK stromal ablation depth <350 microns or expected keratometry >47.2 D, or patients undergoing 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 Criteria12

active infections, collagen vascular disease, allergic to product
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 cognitive or ambulatory conditions that would prevent eye drop compliance with 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.