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

Launched by COHEN LASER AND VISION CENTER · Aug 23, 2022

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a treatment called cornea crosslinking for individuals with keratoconus, a condition where the cornea (the clear front part of the eye) becomes thin and irregularly shaped. The goal is to see if this treatment can help strengthen the cornea and improve vision. The study is currently recruiting participants aged 18 and older who meet specific criteria, including having certain signs of keratoconus and a minimum level of cornea thinning.

Eligible participants can expect to undergo various eye tests to confirm their condition, and if they qualify, they will receive the crosslinking treatment. Throughout the study, they will need to attend follow-up appointments to monitor their progress. It's important to note that individuals with certain eye conditions, active infections, or those who are pregnant or breastfeeding cannot participate. This trial aims to help improve treatment options for people with keratoconus, and participants will be contributing valuable information to this important area of research.

Gender

ALL

Eligibility criteria

• 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:
• • 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 Criteria:
• • 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.