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

NCT04213885 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-08-29

No results posted yet for this study

Summary

To determine whether the Peschke PXL-330 is safe and effective in the treatment of corneal thinning conditions.

Conditions

  • Keratoconus, Unstable
  • Ectasia Corneal
  • Bacterial Keratitis

Interventions

COMBINATION_PRODUCT

PXL 330 Platinum device/Riboflavin

30mW, 5 sec, 5 sec off, 10 minutes of illumination

Sponsors & Collaborators

  • Eye Specialists of Indiana

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-04
Primary Completion
2024-08-05
Completion
2024-08-05
FDA Drug
Yes
FDA Device
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 NCT04213885 on ClinicalTrials.gov