PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution for Bacterial Keratitis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pacific Clear Vision Institute, Eugene, ORBacterial Keratitis+2 MorePXL-330 Platinum device for crosslinking with Peschke ribofflavin solution - CombinationProduct
Eligibility
10 - 45
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new system to treat corneal thinning conditions to see if it is safe and effective.

Eligible Conditions
  • Keratoconus
  • Bacterial Keratitis
  • Unstable Keratoconus

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 1 year

1 year
Best corrected visual acuity
Mean keratometry in diopters

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 ribofflavin solution · No Placebo Group · Phase 1

Pulsed, accelerated
CombinationProduct
Experimental Group · 1 Intervention: PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution · Intervention Types: CombinationProduct
Conventional
CombinationProduct
ActiveComparator Group · 1 Intervention: PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution · Intervention Types: CombinationProduct

Trial Logistics

Trial Timeline

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

Who is running the clinical trial?

Pacific Clear Vision InstituteLead Sponsor
BALAMURALI AMBATI, MD, PhDPrincipal InvestigatorPCVI

Eligibility Criteria

Age 10 - 45 · All Participants · 26 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a Fleischer ring. (Note: I am unable to provide further details as I do not have enough context about the study or medical condition being screened for.)
The topography of your body shows a crab-claw-like appearance.
There is a medical sign called Rizzutti's sign that is being checked for.
If you wear contact lenses, the type you wear determines how long you need to stop wearing them before starting the trial: soft lenses require one week, soft extended wear lenses require two weeks, soft toric lenses require three weeks, and rigid gas permeable or scleral lenses require two weeks for each decade you've been wearing them. The investigator may decide on a case-by-case basis.
This is not a complete criterion. Munson's sign is a medical term used to describe a specific type of dental condition, and it cannot be simplified without additional context.

Who else is applying?

What state do they live in?
Missouri100.0%
What site did they apply to?
Pacific Clear Vision Institute100.0%
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

What are the potential risks associated with Peschke ribofflavin solution and PXL-330 Platinum device crosslinking?

"The safety of the PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution is estimated at a 1 due to its Phase 1 clinical trial status; This indicates that only limited data exists in support of efficacy and safety." - Anonymous Online Contributor

Unverified Answer

How many participants are currently taking part in this medical experiment?

"Affirmative. According to the information posted on clinicaltrials.gov, this investigation is currently recruiting participants with an initial posting date of September 1st 2019 and a recent update occurring on September 14th 2021. In total, 300 patients are needed at one medical centre for the study's completion." - Anonymous Online Contributor

Unverified Answer

Does this trial include participants older than thirty years?

"According to the trial's stipulations, potential participants need to be between 10 and 45 years old." - Anonymous Online Contributor

Unverified Answer

Who is authorized to partake in this scientific experiment?

"This clinical trial is seeking 300 patients with keratoconus aged 10 to 45. To be eligible for the study, applicants must possess an unstable form of the condition." - Anonymous Online Contributor

Unverified Answer

Are there any vacancies for those interested in joining this experiment?

"Affirmative, according to clinicaltrials.gov this research study is still looking for participants. It was first advertised on September 1st 2019 and last updated two years later on September 14th 2021. 300 volunteers are needed from a single site." - 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.