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Procedure
Corneal Collagen Crosslinking for Corneal Ulcer
Phase 2 & 3
Recruiting
Led By Bala Ambati
Research Sponsored by Peschke GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 2 (#+/- 2 study days).
Awards & highlights
Study Summary
This trial is being done to see if the PXL Platinum 330 System is safe and effective for performing corneal collagen crosslinking for the treatment of refractory corneal ulcers.
Who is the study for?
Adults with a central corneal ulcer or hypopyon that hasn't improved after 24 hours of standard antibiotic eye drops, or hasn't fully healed within a week. Participants must be willing to have their cornea cultured for bacteria and follow the visit schedule. Their corneas must be thicker than 300 μm. Those with perforated ulcers, other active infections, previous serious ocular conditions, uncontrolled systemic diseases, pregnancy/lactation, known drug sensitivities, or very deep ulcers are excluded.Check my eligibility
What is being tested?
The trial is testing the PXL Platinum 330 System combined with riboflavin solution against a sham treatment using artificial tears. The system uses UV-A light and riboflavin to strengthen the cornea by inducing collagen crosslinking (CXL), which could help heal stubborn corneal ulcers.See study design
What are the potential side effects?
Potential side effects may include discomfort in the eye during treatment, sensitivity to light post-treatment, temporary vision changes or blurring due to the procedure itself. There's also a risk of infection from any invasive eye procedure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 2 (#+/- 2 study days).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2 (#+/- 2 study days).
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The primary objective of this study is to evaluate the safety and effectiveness of corneal collagen CXL (performed using the PXL-Platinum 330 system with riboflavin solution) for treating refractory corneal ulcers.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Standard of care + CXL + Riboflavin 0.25% TE SolutionExperimental Treatment1 Intervention
Standard of care treatment and the experimental combination product. The PXL Platinum 330 Illumination System is a portable electronic medical device. The device's light emitting diode (LED) is used to deliver a metered dose of UV-A light to a targeted treatment area for illuminating the cornea during corneal collagen CXL. The riboflavin solution is an isotonic (0.9%) sodium chloride solution containing 0.25% riboflavin, 1% hydroxypropylmethylcellulose, and 0.007% benzalkonium chloride, adjusted to a pH of 7.0, and packaged in 2 mL sterile syringes for topical ophthalmic use.
Group II: Standard of care + Sham CXL + Artificial TearsPlacebo Group1 Intervention
Standard-of-care treatment and Sham CXL and administration of artificial tears.
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Who is running the clinical trial?
Peschke GmbHLead Sponsor
1 Previous Clinical Trials
468 Total Patients Enrolled
1 Trials studying Corneal Ulcer
468 Patients Enrolled for Corneal Ulcer
Yvette ViscusoStudy DirectorPeschke GmbH
1 Previous Clinical Trials
468 Total Patients Enrolled
1 Trials studying Corneal Ulcer
468 Patients Enrolled for Corneal Ulcer
Bala AmbatiPrincipal InvestigatorPacific Clear Vision Institute
1 Previous Clinical Trials
468 Total Patients Enrolled
1 Trials studying Corneal Ulcer
468 Patients Enrolled for Corneal Ulcer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to have a corneal culture for an eye infection.I have an eye infection, but it's not in the center of the cornea or causing pus in the eye.I have a hole in my cornea due to an ulcer.I am 18 years old or older.I have had an eye condition that could cause future problems.I do not have an uncontrolled systemic disease affecting my cornea.I have a severe ulcer in my eye.My eye infection hasn't improved with standard antibiotic drops.I have a deep corneal ulcer.I am suspected to have an eye infection needing special eye drops.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of care + Sham CXL + Artificial Tears
- Group 2: Standard of care + CXL + Riboflavin 0.25% TE Solution
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
At how many different hospitals is this research study being conducted?
"This trial has sites in Indianapolis, Indiana; Littleton, Colorado; Columbia, South carolina; and 12 other locations."
Answered by AI
Are people still being accepted into the program?
"The trial is actively recruiting patients, as can be seen from the information available on clinicaltrials.gov. The trial was posted on 3/14/2022 and was most recently edited on 10/26/2022. They are looking for 488 patients at 12 locations."
Answered by AI
What is the cut-off for how many people can join this test group?
"Yes, this is an active clinical trial that is recruiting 488 participants from 12 sites. The first posting was on 3/14/2022, with the most recent update on 10/26/2022."
Answered by AI
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