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Safety and Effectiveness of the PXL-Platinum 330 System for Corneal Cross-Linking

NCT03918408 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-11-12

No results posted yet for this study

Summary

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

Conditions

  • Keratoconus, Unstable
  • Bacterial Keratitis
  • Ectasia of Cornea

Interventions

COMBINATION_PRODUCT

PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution

Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea

Sponsors & Collaborators

  • Pacific Clear Vision Institute

    lead OTHER

Principal Investigators

  • BALAMURALI AMBATI, MD, PhD · PCVI

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2029-12-31
Completion
2030-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03918408 on ClinicalTrials.gov