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Procedure
PXL-330 Platinum device for crosslinking with Peschke riboflavin solution for Keratoconus
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
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
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