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Corneal Collagen Cross-Linking for Keratoconus (CXL Trial)
Phase 2
Waitlist Available
Research Sponsored by Peschke Meditrade, GmbH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age 6 to 18 years
Having a diagnosis of progressive keratoconus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 month
Awards & highlights
CXL Trial Summary
This trial is for a new, less-intense cross-linking treatment for people with progressive keratoconus who can't comply with the current, more-intense treatment procedures required by clinical trials.
Who is the study for?
This trial is for children aged 6 to 18 with progressive keratoconus, a condition affecting the eye's shape. It's specifically for those who can't follow standard treatment protocols due to certain conditions. Participants must be able to attend follow-up visits and have not previously had issues with corneal healing or sensitivity to study medications.Check my eligibility
What is being tested?
The UV-X system is being tested in this trial, which involves using riboflavin (a type of vitamin B2) and UVA light to strengthen the cornea through a process called corneal collagen cross-linking (CXL). This method aims to halt the progression of keratoconus.See study design
What are the potential side effects?
Potential side effects may include discomfort in the eye, temporary vision changes, risk of infection, inflammation or scarring of the cornea. Long-term risks are still being studied but could involve changes in corneal shape.
CXL Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 6 and 18 years old.
Select...
My condition is worsening keratoconus.
CXL Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in keratometry
Secondary outcome measures
Change in manifest refraction spherical equivalent
CXL Trial Design
1Treatment groups
Experimental Treatment
Group I: Corneal collagen cross-linking with riboflavin and UVA lightExperimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
Peschke Meditrade, GmbHLead Sponsor
2 Previous Clinical Trials
35 Total Patients Enrolled
2 Trials studying Keratoconus
35 Patients Enrolled for Keratoconus
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 6 and 18 years old.My eyes have healed slowly after injury or surgery in the past.My eyes have conditions like herpes or corneal issues that could complicate future treatments.My condition is worsening keratoconus.I can attend all scheduled follow-up visits.
Research Study Groups:
This trial has the following groups:- Group 1: Corneal collagen cross-linking with riboflavin and UVA light
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Keratoconus Patient Testimony for trial: Trial Name: NCT00925327 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA authorized Corneal collagen cross-linking with riboflavin/UVA light for use?
"The safety of cross-linking corneal collagen with riboflavin and UVA light has been assessed at a 2 on the scale from 1 to 3. This is due to there being preliminary data supporting safety but not yet any evidence for efficacy in clinical trials."
Answered by AI
Is the eligibility criterion for this research restricted to adults over twenty?
"Per this clinical trial's requirements, minors aged 6 to 18 can be enrolled."
Answered by AI
What particular demographic would be most appropriate for this investigation?
"The criteria for enrollment into this trial stipulates that patients must have a diagnosis of progressive keratoconus and be within the age range 6 to 18. Only 7 individuals will ultimately qualify for inclusion."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
1
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.
PatientReceived 2+ prior treatments
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