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

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

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

Study Overview

• Status: Completed
• 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 (Actual): 200
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

Subjects who have one or both eyes that meet criteria 1-4 and also meet at least 1 or more of criteria 5-11 will be considered candidates for this study:

1. 8 years of age or older
2. Signed written informed consent
3. Willingness and ability to comply with schedule for follow-up visits

4. Contact Lens Wearers Only:

   1. Removal of contact lenses for the required period of time prior to the screening refraction:

      Contact Lens Type Minimum Discontinuation Time Soft 3 days Soft Extended Wear 3 days Soft Toric 3 days Rigid gas permeable 2 Weeks

   2. Subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses.
5. Presence of central or inferior steepening.
6. Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration

7. 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. Rizzutti's sign
   6. Apical Corneal scarring consistent with Bowman's breaks
   7. Scissoring of the retinoscopic reflex
   8. Crab-claw appearance on topography
8. Steepest keratometry (Kmax) value ≥ 47.20 D
9. I-S keratometry difference > 1.5 D on the Pentacam/Orbscan map or topography map
10. Posterior corneal elevation >16 microns
11. Thinnest corneal point >300 microns

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 6mW/cm2; 6mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 30 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 4mW/cm2; 4mW/cm2, with pulsed mode, 10 seconds on, 10 second off, for 45 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cornea Associates of Texas
• Investigators: Principal Investigator: Tyrone McCall, MD, Cornea Associates of Texas

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2020
• Primary Completion (Actual): May 5, 2022
• Study Completion (Actual): May 5, 2022

Study Registration Dates

• First Submitted: November 22, 2019
• First Submitted That Met QC Criteria: November 22, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 17, 2022
• Last Verified: September 1, 2022

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will be held in a secure location. While summary outcomes data will be provided on request to other researchers and periodically at scientific conferences, protected health information will not.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes