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Procedure

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
Must not have
Previous ocular condition in the eye(s) to be treated that may predispose the eye for future complications (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

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.
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.
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 6 and 18 years old.
Select...
My condition is worsening keratoconus.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My eyes have conditions like herpes or corneal issues that could complicate future treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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

Corneal collagen cross-linking with riboflavin/UVA light (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT00925327 — Phase 2
Keratoconus Research Study Groups: Corneal collagen cross-linking with riboflavin and UVA light
Keratoconus Clinical Trial 2023: Corneal collagen cross-linking with riboflavin/UVA light Highlights & Side Effects. Trial Name: NCT00925327 — Phase 2
Corneal collagen cross-linking with riboflavin/UVA light (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00925327 — Phase 2
Keratoconus Patient Testimony for trial: Trial Name: NCT00925327 — Phase 2
~5 spots leftby Nov 2025
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