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

NCT04094090 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2025-10-17

No results posted yet for this study

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.

Conditions

  • Keratoconus
  • Pellucid Marginal Corneal Degeneration
  • Corneal Ectasia

Interventions

COMBINATION_PRODUCT

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

Sponsors & Collaborators

  • Goodman Eye Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-19
Primary Completion
2029-10-19
Completion
2029-10-19
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04094090 on ClinicalTrials.gov