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Safety and Efficacy of Corneal Crosslinking Using the PXL-Platinum 330 for Eyes With Corneal Ectatic Conditions

NCT04240457 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2024-12-12

Study results available
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Summary

To evaluate the safety and effectiveness of the PXL Platinum 330 device for performing Corneal Crosslinking in patients with corneal thinning conditions.

Conditions

  • Keratoconus
  • Cornea Ectasia

Interventions

COMBINATION_PRODUCT

Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.

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

  • Arbor Center for Eye Care

    lead OTHER

Principal Investigators

  • David Lubeck, MD · Arbor Center for Eye Care

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-08
Primary Completion
2023-02-18
Completion
2023-02-18
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 NCT04240457 on ClinicalTrials.gov