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

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, pachymetry, and visual function questionnaire.

• Study Type: Interventional
• Enrollment (Anticipated): 500
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • Recruiting
      • Goodman Eye Center
      • Contact: Daniel F Goodman, MD; Phone Number: 415-474-3333; Email: swong@goodmaneyecenter.com
      • Principal Investigator: Daniel F Goodman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulsed, accelerated; 4 mW, 10-15 sec on, 10-15sec off, 45 minutes of illumination Intervention: Combination Product: 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 crosslinking
Experimental: Pusled, accelerated; 8 mW, 10-15 sec on, 10-15 sec off, 22.5 minutes of illumination Intervention: Combination Product: 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 crosslinking

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best-contact corrected visual acuity (BSCVA)	Change in BSCVA compared to baseline.	3, 6, and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected visual acuity	Change in UCVA compared to baseline.	3, 6, and 12 months
Keratometry	Change in Kmax, compared to baseline.	1 year

Collaborators and Investigators

• Sponsor: Goodman Eye Center

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2019
• Primary Completion (Anticipated): October 19, 2024
• Study Completion (Anticipated): December 19, 2024

Study Registration Dates

• First Submitted: September 13, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (Actual): September 18, 2019

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 19, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Pathological Conditions, Anatomical; Keratoconus; Dilatation, Pathologic; Corneal Diseases; Physiological Effects of Drugs; Photosensitizing Agents; Dermatologic Agents; Micronutrients; Vitamins; Vitamin B Complex; Riboflavin
• Other Study ID Numbers: PXL-2211

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: No