PXL-330 Platinum device for crosslinking with Peschke riboflavin solution for Keratoconus

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Goodman Eye Center, San Francisco, CAKeratoconus+2 MorePXL-330 Platinum device for crosslinking with Peschke riboflavin solution - CombinationProduct
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test a new system for corneal cross-linking, a treatment for ectatic disorders. The goal is to see if it is safe and effective.

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

Treatment Effectiveness

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: 1 year

1 year
Keratometry
Month 12
Best-contact corrected visual acuity (BSCVA)
Uncorrected visual acuity
6 months
Corrected distance visual acuity

Trial Safety

Trial Design

2 Treatment Groups

Pulsed, accelerated
1 of 2
Pusled, accelerated
1 of 2

Experimental Treatment

500 Total Participants · 2 Treatment Groups

Primary Treatment: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution · No Placebo Group · Phase 2

Pulsed, accelerated
CombinationProduct
Experimental Group · 1 Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution · Intervention Types: CombinationProduct
Pusled, accelerated
CombinationProduct
Experimental Group · 1 Intervention: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution · Intervention Types: CombinationProduct
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Platinum
Not yet FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year

Who is running the clinical trial?

Goodman Eye CenterLead Sponsor

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

What state do they live in?
Missouri100.0%
What site did they apply to?
Goodman Eye Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
Why did patients apply to this trial?
  • "I have progressive KC in both eyes treated left in 2018 and needing treatment in right after condition worsening. Ideally help can keep me from further issues and help others dealing with my illness."
How many prior treatments have patients received?
1100.0%

Frequently Asked Questions

How many people are included in this research project?

"That is correct, the listing on clinicaltrials.gov does reveal that this trial has an open call for participants. This particular trial was first made public on October 19th, 2019 and had new information posted as recently as August 19th, 2020. They are looking to enroll 500 individuals at a single location." - Anonymous Online Contributor

Unverified Answer

Has the PXL-330 Platinum device received FDA approval to be used in conjunction with Peschke riboflavin solution?

"The PXL-330 Platinum device for crosslinking with Peschke riboflavin solution is a new medical intervention, and as such has received a score of 2 in terms of safety." - Anonymous Online Contributor

Unverified Answer

How is the PXL-330 Platinum device most commonly used in conjunction with Peschke riboflavin solution?

"The PXL-330 Platinum device, when used in conjunction with Peschke riboflavin solution, is a popular tool for dietary and nutritional therapies. However, it has also shown therapeutic value for treating vitamin deficiency, joint pain, and other ailments." - Anonymous Online Contributor

Unverified Answer

Are patients being signed up for this clinical trial right now?

"This clinical trial is currently seeking participants. The trial was first posted on October 19, 2019 and was last updated on August 19, 2020." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.