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Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking in Eyes With Corneal Ectasia | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT04094090•Goodman Eye Center

View on ClinicalTrials.gov

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.

Eligibility

Age

10 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

Goodman Eye Center

San Francisco, California, United States

Key Dates

Start Date

October 19, 2019

Primary Completion Date

October 19, 2029

Completion Date

October 19, 2029

Last Updated

October 20, 2025

Enrollment

500

ESTIMATED participants

Conditions

KeratoconusPellucid Marginal Corneal DegenerationCorneal Ectasia

Interventions

PXL-330 Platinum device for crosslinking with Peschke riboflavin solution

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 20, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

PRoTECT: Corneal Wavefront Guided PRK + Epi-off CXL vs. PTK+Epi-off CXL in Keratoconus

First in Human Study to Assess Safety and Efficacy of an Implantable Nitinol Device in the Treatment of Keratoconus

A Study to Test the Diagnostic Potential of Brillouin Microscopy for Corneal Ectasia

Scleral Lens Fitting Using Wide-Field OCT

OCT in Diagnosis of Irregular Corneas

Clinical Investigation for a Multifunction Ophthalmic Measurement Device