Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Keratoconus; Corneal Ectasia; Pellucid Marginal Corneal Degeneration; Corneal Degeneration
• Intervention / Treatment: Combination product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Detailed Description

Patients with progressive keratoconus, pellucid marginal degeneration, or at risk for post-refractive corneal ectasia will be recruited and undergo epithelial-on corneal crosslinking with the Peschke PXL-330 system using pulsed, accelerated energy delivery. Patients will undergo monitoring for 1 year, with serial measurements of corneal topography, visual acuity, pachymetry, and visual function.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Jennifer Seale, COT; Phone Number: 131 12146920146; Email: jseale@corneatexas.com
• Study Contact Backup: Name: Tyrone McCall, MD; Phone Number: 12146920146; Email: tyrone.mccall@gmail.com

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75231
      • Cornea Associates of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 8 years of age or older
• Signed written informed consent
• Willingness and ability to comply with schedule for follow-up visits
• Contact Lens Wearers Only:
• Removal of contact lenses (if applicable) for the required period of time prior to the screening refraction: Soft, discontinue 3 days; Soft Extended Wear, discontinue 3 days; Soft Toric, discontinue 3 days; Rigid gas permeable, discontinue 2 Weeks (subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses)

And one or more of the following:

• Presence of central or inferior steepening.
• Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
• Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, 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/Orbscan map or topography map
• Posterior corneal elevation >16 microns
• Thinnest corneal point >300 microns

Exclusion Criteria:

• Eyes classified as either normal or atypical normal on the severity grading scheme.
• Corneal thickness < 300 microns measured by ultrasonic pachymetry or pentacam.
• 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, 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 a current condition that, in the physician's opinion, would interfere with or prolong epithelial healing

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulsed 5mW/cm2; 5mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 36 minute total treatment time	Combination product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution; Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea; Other Names: Corneal Crosslinking
Experimental: Pulsed 8mW/cm2; 8mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 22 minute and 30 seconds total treatment time	Combination product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution; Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea; Other Names: Corneal Crosslinking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
K-Max	Change in K-Max measured by corneal topography, compared to baseline	12 Months
K-Mean	Change in K-Mean measured by corneal topography, compared to baseline	12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected Visual Acuity	Change in uncorrected corrected visual acuity using snellen measurements, compared to baseline	12 Months
Best Corrected Visual Acuity	Change in best corrected visual acuity using snellen measurements, compared to baseline	12 Months
Central Pachymetry	Change in central pachymetry, measured by Pentacam compared to baseline	12 Months

Collaborators and Investigators

• Sponsor: Cornea Associates of Texas

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): August 31, 2024

Study Registration Dates

• First Submitted: December 2, 2020
• First Submitted That Met QC Criteria: December 8, 2020
• First Posted (Actual): December 14, 2020

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 31, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Genetic Diseases, Inborn; Eye Diseases, Hereditary; Corneal Diseases; Keratoconus; Corneal Dystrophies, Hereditary; Physiological Effects of Drugs; Photosensitizing Agents; Dermatologic Agents; Micronutrients; Vitamins; Vitamin B Complex; Riboflavin
• Other Study ID Numbers: PXL-330-CAT-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No