Safety and Effectiveness of the PXL-Platinum 330 System

Phase 1

• Conditions: Corneal Ectasia; Keratoconus; Pellucid Marginal Corneal Degeneration
• Interventions: Combination Product: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

• Registration Number: NCT04401865
• Lead Sponsor: Colorado Eye Consultants/Cornea Consultants of Colorado

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-05-20
• Study First Submitted QC: 2020-05-20
• Study First Posted: 2020-05-26
• Study Start: 2020-06-01
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-24
• Last Update Posted: 2022-01-25
• Primary Completion: 2022-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pulsed, Accelerated	PXL-330 Platinum device for crosslinking with Peschke riboflavin solution	5 mW, 10 sec on, 10 sec off, 24 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
Conventional	PXL-330 Platinum device for crosslinking with Peschke riboflavin solution	4 mW, 10 sec on, 10 sec off, 30 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Uncorrected visual acuity	6 months	Change in UCVA at 6 months, compared to baseline.
Keratometry	12 months	Change in Kmax, compared to baseline.

Trial Locations

Locations (3)

Colorado Eye Consultants/Corneal Consultants of Colorado; 🇺🇸 Littleton, Colorado, United States

Chicago Cornea Consultants, Ltd.; 🇺🇸 Highland Park, Illinois, United States

Cleveland Eye Clinic; 🇺🇸 Brecksville, Ohio, United States