PXL-330 Platinum device for crosslinking with Peschke riboflavin solution for Keratoconus
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.
- Keratoconus
- Corneal Ectasia
- Pellucid Marginal Corneal Degeneration
Treatment Effectiveness
Study Objectives
1 Primary · 2 Secondary · Reporting Duration: 12 months
Trial Safety
Trial Design
2 Treatment Groups
Conventional
1 of 2
Pulsed, Accelerated
1 of 2
Active Control
Experimental Treatment
300 Total Participants · 2 Treatment Groups
Primary Treatment: PXL-330 Platinum device for crosslinking with Peschke riboflavin solution · No Placebo Group · Phase 1 & 2
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age Any Age · All Participants · 5 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:Who else is applying?
What state do they live in?
| Missouri | 50.0% |
| Texas | 50.0% |
How old are they?
| 18 - 65 | 100.0% |
What site did they apply to?
| Colorado Eye Consultants/Corneal Consultants of Colorado | 100.0% |
What portion of applicants met pre-screening criteria?
| Met criteria | 100.0% |
Why did patients apply to this trial?
- "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."
How many prior treatments have patients received?
| 1 | 100.0% |
Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor