Safety and Efficacy of Corneal Crosslinking Using the PXL-Platinum 330 for Eyes With Corneal Ectatic Conditions

Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Crosslinking in Eyes With Corneal Ectatic Conditions

To evaluate the safety and effectiveness of the PXL Platinum 330 device for performing Corneal Crosslinking in patients with corneal thinning conditions.

Study Overview

• Status: Terminated
• Conditions: Keratoconus; Cornea Ectasia
• Intervention / Treatment: Combination product: Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.

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 visual function questionnaire assessments.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Orland Park, Illinois, United States, 60467
      • Arbor Center for Eye Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inclusion Criteria: Criterion 1,2,3 are required for all participants. Participants must also meet one or more of criteria 4-12 . Criterion 13 is relevant only for contact lens wearers

Subjects who have one or both eyes that meet criteria 1 and one 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 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 in keratoconus suspect eyes

10. Contact Lens Wearers Only:

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

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

13. 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 1 Week, Soft Extended Wear 2 Weeks, Soft Toric 3 Weeks, Rigid Gas Permeable 2 Weeks per decade of wear

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

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, acanthamoeba, 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: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pulsed, accelerated; 18mW, 5 seconds on, 5 seconds off, 10 minutes of illumination.	Combination product: Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.; 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.
Active Comparator: Conventional; 9mW continuous, 10 minutes of illumination.	Combination product: Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.; 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.

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 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: Arbor Center for Eye Care

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2020
• Primary Completion (Actual): February 18, 2023
• Study Completion (Actual): February 18, 2023

Study Registration Dates

• First Submitted: January 22, 2020
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (Actual): January 27, 2020

Study Record Updates

• Last Update Posted (Actual): March 31, 2023
• Last Update Submitted That Met QC Criteria: March 29, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Keratoconus
• Other Study ID Numbers: 330019

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