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Procedure

Safety and Effectiveness of the PXL-Platinum 330 System

Phase 1 & 2
Waitlist Available
Led By S. Lance Forstot, M.D.
Research Sponsored by Colorado Eye Consultants/Cornea Consultants of Colorado
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a special light treatment called the PXL Platinum 330 system to help strengthen the cornea in patients with conditions that make it weak and misshapen. The treatment works by creating new bonds in the cornea to make it more stable. This method has been used for many years to stop the progression of keratoconus and other similar corneal diseases by strengthening the cornea using a combination of riboflavin and ultraviolet A light.

Eligible Conditions
  • Keratoconus
  • Pellucid Marginal Corneal Degeneration
  • Corneal Ectasia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Corrected distance visual acuity
Secondary study objectives
Keratometry
Uncorrected visual acuity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pulsed, AcceleratedExperimental Treatment1 Intervention
5 mW, 10 sec on, 10 sec off, 24 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
Group II: ConventionalActive Control1 Intervention
4 mW, 10 sec on, 10 sec off, 30 minutes of illumination Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PXL-330 Platinum device for crosslinking with Peschke riboflavin solution
2020
Completed Phase 1
~200

Find a Location

Who is running the clinical trial?

Colorado Eye Consultants/Cornea Consultants of ColoradoLead Sponsor
S. Lance Forstot, M.D.Principal InvestigatorColorado Eye Consultants/Corneal Consultants of Colorado
~55 spots leftby Dec 2025
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