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Safety and Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

NCT04177082 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-10-19

No results posted yet for this study

Summary

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

Conditions

  • Keratoconus
  • Pellucid Marginal Corneal Degeneration
  • 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

  • Cornea Associates of Texas

    lead OTHER

Principal Investigators

  • Tyrone McCall, MD · Cornea Associates of Texas

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-10
Primary Completion
2022-05-05
Completion
2022-05-05
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 NCT04177082 on ClinicalTrials.gov