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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
Diagnosis of keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid marginal degeneration, forme fruste pellucid marginal degeneration, history of radial keratotomy with fluctuating vision, Terrien's marginal degeneration.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights

Study Summary

This trial will test a new machine that uses a different method to do cross-linking, to see if it is effective and safe.

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have certain eye conditions including keratoconus, post-LASIK ectasia, pellucid marginal degeneration, or a history of radial keratotomy that can lead to unstable vision.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Corrected distance visual acuity
Secondary outcome measures
Keratometry
Uncorrected visual acuity

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit for enrolment in this research?

"Affirmative. The details hosted on clinicaltrials.gov verify that this clinical trial is actively seeking participants, and it was initially posted on June 1st 2020 before being updated lastly on January 24th 2022. This study requires 300 individuals to be recruited from two distinct locations."

Answered by AI

Has research been conducted on the efficacy of using a PXL-330 Platinum device in tandem with Peschke riboflavin solution for crosslinking?

"The PXL-330 Platinum device, combined with Peschke riboflavin solution for crosslinking, was first researched in 2002 at the National Cancer Centre of Chinese Academy of Medical Sciences (CAMS) and Peking Union Medical College (PUMC). To date, 121 trials have been completed while there are currently 177 clinical studies recruiting participants; many located in Brecksville, Ohio."

Answered by AI

What medical conditions tend to be treated with the PXL-330 Platinum device coupled with Peschke riboflavin solution?

"PXL-330 Platinum device combined with Peschke riboflavin solution is most commonly prescribed as nutritional therapy. It can also be taken to alleviate a range of conditions including vitamin deficiency, joint discomfort and supplementing vitamins."

Answered by AI

Are there any slots currently open for enrollment in this research endeavor?

"Affirmative. Clinicaltrials.gov documents confirm that this investigation was launched on June 1st 2020 and is accepting applicants at present. The trial site requires 300 volunteers from 2 locations to take part in the study."

Answered by AI

Who else is applying?

What state do they live in?
Missouri
Texas
Other
Virginia
How old are they?
18 - 65
What site did they apply to?
Colorado Eye Consultants/Corneal Consultants of Colorado
Cleveland Eye Clinic
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
0

Why did patients apply to this trial?

I’m hoping this clinical trial will help my medical condition. Currently I am using scleral lens. I learned of my diagnosis in October of 2022 and my vision changes started in 2015. I am currently a grad student in Florida for my DNP as a CRNA. The down time from epi-off CXL is to long with major risk at this point in my program.
PatientReceived 2+ prior treatments
I have progressive Keratoconus and received corneal cross linking in my left eye. Upon further testing I have been referred to treat my right eye. Expense is a concern. I want to help others with my condition to prevent further issues and prevent a corneal transplant in my future.
PatientReceived no prior treatments

What questions have other patients asked about this trial?

When does the study start and when would expectation be to have the study conducted?
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
Safety and Effectiveness of the PXL-Platinum 330 System
2020. "Safety and Effectiveness of the PXL-Platinum 330 System". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04401865.
~62 spots leftby Apr 2025
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