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

Phase 2

Recruiting

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

• Registration Number: NCT04094090
• Lead Sponsor: Goodman Eye Center

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, pachymetry, and visual function questionnaire.

Study Timeline

• Study First Submitted: 2019-09-13
• Study First Submitted QC: 2019-09-16
• Study First Posted: 2019-09-18
• Study Start: 2019-10-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2029-10-19
• Study Completion: 2029-10-19

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pulsed, accelerated	PXL-330 Platinum device for crosslinking with Peschke riboflavin solution	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
Pusled, accelerated	PXL-330 Platinum device for crosslinking with Peschke riboflavin solution	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

Primary Outcome Measures

Name	Time	Method
Best-contact corrected visual acuity (BSCVA)	3, 6, and 12 months	Change in BSCVA compared to baseline.

Secondary Outcome Measures

Name	Time	Method
Uncorrected visual acuity	3, 6, and 12 months	Change in UCVA compared to baseline.
Keratometry	1 year	Change in Kmax, compared to baseline.

Trial Locations

Locations (1)

Goodman Eye Center; 🇺🇸 San Francisco, California, United States