MedTrace Logo

Safety and Effectiveness of the PXL-Platinum 330 System

NCT04401865 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2022-01-25

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

  • Corneal Ectasia
  • Keratoconus
  • Pellucid Marginal Corneal Degeneration

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

  • Colorado Eye Consultants/Cornea Consultants of Colorado

    lead INDUSTRY

Principal Investigators

  • S. Lance Forstot, M.D. · Colorado Eye Consultants/Corneal Consultants of Colorado

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2022-06-30
Completion
2023-06-30
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 NCT04401865 on ClinicalTrials.gov