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UV-A Light + Riboflavin for Corneal Ulcers
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 testing a new system to treat corneal ulcers with UV-A light and riboflavin solution. The goal is to improve the biomechanical properties of the cornea by strengthening the corneal tissue.
Who is the study for?
This trial is for adults with untreated corneal ulcers who haven't used antibiotic eye drops in the last 30 days. Participants must consent to a corneal culture, sign an informed consent form, and have a minimum corneal thickness greater than 300 μm. It excludes pregnant or lactating individuals, those with deep or perforated ulcers, other active eye infections, uncontrolled systemic diseases affecting the eyes, known drug sensitivities, or conditions preventing steady gaze during treatment.Check my eligibility
What is being tested?
The study tests the PXL Platinum 330 System combined with riboflavin solution for treating corneal ulcers through collagen crosslinking (CXL). The process involves pretreating the ulcer with riboflavin solution before exposing it to UV-A light to strengthen the cornea. This method is compared against standard care plus sham CXL and artificial tears.See study design
What are the potential side effects?
Potential side effects may include discomfort from UV exposure such as temporary visual disturbances or irritation. There's also a risk of infection due to procedure-related breaches in ocular surface integrity.
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
Collagen Diseases
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Standard of Care Therapy + CXL + Riboflavin 0.23% L SolutionExperimental Treatment1 Intervention
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. PESCHKE-L Solution is a riboflavin 5'-phosphate 0.23% ophthalmic solution that functions as a photosensitizer and is indicated for use with the PXL Platinum 330 Illumination System. Designed to be used when there is epithelial disruption as can occur with a corneal ulcer or wound. It does not contain benzalkonium chloride. It is intended to achieve rapid absorption.
Group II: Standard of Care Therapy + 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
488 Total Patients Enrolled
1 Trials studying Corneal Ulcer
488 Patients Enrolled for Corneal Ulcer
Yvette ViscusoStudy DirectorPeschke GmbH
1 Previous Clinical Trials
488 Total Patients Enrolled
1 Trials studying Corneal Ulcer
488 Patients Enrolled for Corneal Ulcer
Bala AmbatiPrincipal InvestigatorPacific Clear Vision Institute
1 Previous Clinical Trials
488 Total Patients Enrolled
1 Trials studying Corneal Ulcer
488 Patients Enrolled for Corneal Ulcer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- One or both of my eyes meet the study's requirements.I have a deep corneal ulcer.I do not have any conditions like nystagmus that would prevent me from keeping my gaze steady.I am suspected to have an eye infection needing special eye drops.I have a hole in my cornea due to an ulcer.I am 18 years old or older.I have an eye infection, but it's only in my cornea.I have a severe ulcer in my eye that has affected its deeper layers.I have had an eye condition that could cause future problems.I haven't used antibiotic eyedrops for ulcers in the last 30 days.I do not have an uncontrolled systemic disease affecting my cornea.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care Therapy + Sham CXL + Artificial Tears
- Group 2: Standard of Care Therapy + CXL + Riboflavin 0.23% L 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.
How many individuals are participating in this test?
"In order to have this trial, 468 people who meet the set inclusion criteria must agree to participate. This can happen at different locations like Gorovoy M.D Eye Specialists in Fort Myers, Florida and Colorado Eye Consultants in Littleton, Colorado."
Answered by AI
Are there any available vacancies for this clinical trial?
"This study is looking for patients who fit the criteria and are willing to be a part of the trial. The trial was first posted on 3/14/2022 and was last updated on 10/26/2022."
Answered by AI
Are clinical trials for this medication plentiful in Canada?
"There are a dozen enrolment sites for this trial, distributed among Fort Myers, Littleton, Columbia and 12 other cities. If you're interested in participating in the clinical trial, try to select the clinic closest to your location to reduce travel time."
Answered by AI
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