Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia

Launched by GOODMAN EYE CENTER · Sep 16, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called the PXL Platinum 330 system, which is designed to help strengthen the cornea (the clear front part of the eye) in individuals with conditions like keratoconus, pellucid marginal degeneration, and other forms of corneal ectasia. These conditions can cause the cornea to become weak and bulge, affecting vision. The researchers want to find out if this new system is safe and effective for patients who have these eye issues.

To participate in the trial, candidates must be at least 10 years old and have specific eye characteristics related to their condition, such as steepening of the cornea or other signs of keratoconus. However, those with certain eye diseases, very thin corneas, or other health issues that could complicate treatment will not be eligible. Participants will undergo the corneal cross-linking procedure and will be monitored for their safety and how well the treatment works. It's important to note that this trial is currently recruiting participants, so if you or someone you know is interested, you might want to discuss it with an eye care specialist.

Gender

ALL

Eligibility criteria

• 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.