Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking

Launched by PACIFIC CLEAR VISION INSTITUTE · Apr 16, 2019

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a new treatment called the PXL-330 system for people with corneal thinning conditions, such as keratoconus and unstable bacterial keratitis. Keratoconus is a condition where the cornea, the clear front part of the eye, becomes thin and bulges out, which can cause vision problems. The trial is open to individuals aged 12 and older who have specific signs of these conditions, like steepening of the cornea or other related eye findings.

Participants can expect to undergo treatment with the PXL-330 system, and they will be closely monitored throughout the study. To be eligible, participants must meet certain criteria, such as having a minimum corneal thickness and specific topography results. It's important to note that individuals with certain eye diseases or conditions, or those who are pregnant or breastfeeding, cannot join the trial. If you're interested in learning more, this trial is currently recruiting participants, and your eye care provider can help determine if you might qualify.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subjects who have one or both eyes that meet criteria 1 \& 2 and 1 or more of the following criteria will be considered candidates for this study.
• • 12 years of age or older
• • Evidence of progressive keratoconus (based on the discretion of the physician as evidenced by an increase in astigmatism, asymmetry, or worsening vision in the last 3 or more months)
• • Presence of central or inferior steepening.
• • Axial topography consistent with keratoconus
• * Presence of one or more findings associated with keratoconus 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
• • I-S keratometry difference \> 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map
• • Posterior corneal elevation \>16 microns
• • Thinnest corneal point \<485 microns
• • AvaGen (Avellino Labs) genetic testing keratoconus risk score of 67 or higher (high risk).
• • Signed written informed consent
• • Willingness and ability to comply with schedule for follow-up visits
• * For 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
• • Scleral Lenses
• • Investigator Discretion \[Discontinuation of scleral lenses not required unless there is clinical evidence of corneal hypoxia (e.g. corneal neovascularization) at time of screening\]
• • Signed written informed consent
• • Willingness and ability to comply with schedule for follow-up visits
• Exclusion Criteria (any of the following are reasons for exclusion):
• • Eyes classified as either normal or atypical normal on the severity grading scheme.
• • Corneal pachymetry at the screening exam that is \<330 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 nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests.
• • Patients with active medical implants (e.g. cardiac pacemakers)'
• • Patients who are aphakic/ pseudophakic