Safety and Effectiveness of the PXL-Platinum 330 System

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

To evaluate the safety and effectiveness of the PXL Platinum 330 system for performing corneal cross-linking (CXL) for the treatment of ectatic disorders.

Study Overview

• Status: Recruiting
• Conditions: Keratoconus; Corneal Ectasia; Pellucid Marginal 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, intraocular pressure, and pachymetry.

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Shivam Patel, BS; Phone Number: 720-709-7523; Email: spatel@corneaonline.com
• Study Contact Backup: Name: Wendy Bigger; Phone Number: 720-709-7533; Email: wbigger@corneaonline.com

Study Locations

• United States
  • Colorado
    • Littleton, Colorado, United States, 80120
      • Recruiting
      • Colorado Eye Consultants/Corneal Consultants of Colorado
      • Contact: Shivam Patel, BS; Phone Number: 720-709-7523; Email: spatel@corneaonline.com
      • Contact: Wendy Bigger; Phone Number: 720-709-7533; Email: wbigger@corneaonline.com
      • Principal Investigator: S. Lance Forstot, M.D.
      • Sub-Investigator: Robert I Fish, M.D.
      • Sub-Investigator: Karen M Repine, M.D.
  • Illinois
    • Highland Park, Illinois, United States, 60035
      • Active, not recruiting
      • Chicago Cornea Consultants, Ltd.
  • Ohio
    • Brecksville, Ohio, United States, 44141
      • Recruiting
      • Cleveland Eye Clinic
      • Sub-Investigator: William Wiley, MD
      • Sub-Investigator: Kathleen Jee, MD
      • Sub-Investigator: Jeffrey Augustine, OD
      • Sub-Investigator: Kayla Karpuk, OD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Diagnosis of keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid marginal degeneration, forme fruste pellucid marginal degeneration, history of radial keratotomy with fluctuating vision, Terrien's marginal degeneration.
2. Must have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form.
3. Must be willing and able to return for scheduled treatment and follow-up examinations for the duration of the study.
4. Must be at least 8 years of age.
5. Non-consenting/impaired individuals with a LAR's signature

Exclusion Criteria:

1. Corneal thickness < 300 microns measured by ultrasound or Pentacam.
2. Contraindications or sensitivities to any study medications or their components.
3. Pregnancy or breastfeeding.
4. Any history of Herpes simplex corneal disease in an eye to be treated.
5. Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment.
6. Inability to cooperate with diagnostic tests.
7. Current enrollment in another ophthalmic clinical trial.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Pulsed, Accelerated; 5 mW, 10 sec on, 10 sec off, 24 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution	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 cross-linking
ACTIVE_COMPARATOR: Conventional; 4 mW, 10 sec on, 10 sec off, 30 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution	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 cross-linking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corrected distance visual acuity	Change in corrected distance visual acuity (CDVA) at the last required study visit (6 months post-op), compared to baseline.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected visual acuity	Change in UCVA at 6 months, compared to baseline.	6 months
Keratometry	Change in Kmax, compared to baseline.	12 months

Collaborators and Investigators

• Sponsor: Colorado Eye Consultants/Cornea Consultants of Colorado
• Investigators: Principal Investigator: S. Lance Forstot, M.D., Colorado Eye Consultants/Corneal Consultants of Colorado

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2020
• Primary Completion (ANTICIPATED): June 30, 2022
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: May 20, 2020
• First Submitted That Met QC Criteria: May 20, 2020
• First Posted (ACTUAL): May 26, 2020

Study Record Updates

• Last Update Posted (ACTUAL): January 25, 2022
• Last Update Submitted That Met QC Criteria: January 24, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

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

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: Yes
• product manufactured in and exported from the U.S.: No