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

To determine whether the Peschke PXL-330 system is safe and effective in the treatment of corneal thinning conditions.

Study Overview

• Status: Recruiting
• Conditions: Keratoconus, Unstable; Bacterial Keratitis; Ectasia of Cornea
• Intervention / Treatment: Combination product: PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution

Detailed Description

Patients with progressive keratoconus, pellucid marginal degeneration, infectious keratitis, 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 visual function questionnaire.

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

Contacts and Locations

• Study Contact: Name: BALAMURALI AMBATI, MD, PhD; Phone Number: 541-343-5000; Email: bambati@pcvi.com
• Study Contact Backup: Name: Scott Cherne, MD; Phone Number: 541-343-5000; Email: scherne@pcvi.com

Study Locations

• United States
  • Oregon
    • Eugene, Oregon, United States, 97401
      • Recruiting
      • Pacific Clear Vision Institute
      • Contact: BALAMURALI AMBATI, MD; Phone Number: 706-231-3958; Email: bambati@pcvi.com
      • Contact: Scott K Cherne, MD; Phone Number: 5413435000; Email: scherne@pcvi.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 45 years (Child, 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. 12 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. Rizzutti's sign
   6. Apical Corneal scarring consistent with Bowman's breaks
   7. Scissoring of the retinoscopic reflex
   8. Crab-claw appearance on topography
5. Steepest keratometry (Kmax) value ≥ 47.20 D
6. I-S keratometry difference > 1.5 D on the Pentacam/Galilei/Orbscan/Cassini map or topography map
7. Posterior corneal elevation >16 microns
8. Thinnest corneal point <485 microns
9. Predicted Post LASIK/PRK stromal ablation depth <350 microns or expected keratometry >47.2 D, or patients undergoing PRK/SMILE in keratoconus suspect eyes
10. AvaGen (Avellino Labs) genetic testing keratoconus risk score of 67 or higher (high risk).
11. Bacterial or fungal corneal keratitis persistent and not responding despite > 2 weeks of standard antimicrobial therapy or with rapid progression of corneal thinning, with loss of >25% corneal thickness

12. 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 1 Week Soft Extended Wear 2 Weeks Soft Toric 3 Weeks Rigid gas permeable Scleral Lenses 2 Weeks per decade of wear Investigator Discretion

    Discontinuation of scleral lenses not required unless there is clinical evidence of corneal hypoxia (e.g. corneal neovascularization) at time of screening.

13. Signed written informed consent
14. Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria (any of the following are reasons for exclusion):

1. 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: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional; 9 mW, continuous 10 minutes of illumination	Combination product: PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution; Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea; Other Names: Corneal crosslinking
Experimental: Pulsed, accelerated; 18 mW, 5 sec, 5 sec off, 10 minutes of illumination	Combination product: PXL-330 Platinum device for crosslinking with Peschke ribofflavin 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
Mean keratometry in diopters	Average keratometry across the anterior topography of the cornea computed by a validated Scheimpflug topographer	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual acuity	Measurement of best corrected visual acuity on the validated early-treatment diabetic retinopathy study scale	1 year

Collaborators and Investigators

• Sponsor: Pacific Clear Vision Institute
• Investigators: Principal Investigator: BALAMURALI AMBATI, MD, PhD, PCVI

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Anticipated): June 1, 2029
• Study Completion (Anticipated): June 1, 2030

Study Registration Dates

• First Submitted: April 14, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 17, 2019

Study Record Updates

• Last Update Posted (Actual): January 3, 2023
• Last Update Submitted That Met QC Criteria: December 29, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratitis; Keratoconus
• Other Study ID Numbers: 1005312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Individual participant data will be help 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