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Crosslinking Agent

Corneal Collagen Crosslinking for Keratoconus

Phase 3
Waitlist Available
Led By Peter Hersh, MD
Research Sponsored by Cornea and Laser Eye Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
18 years of age or older
A diagnosis of keratoconus or a diagnosis of corneal ectasia after corneal refractive surgery
Must not have
Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications
Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months
Awards & highlights
No Placebo-Only Group
Pivotal Trial

Summary

This trial is testing a new, safer method of crosslinking that doesn't require removal of the surface epithelial cells.

Who is the study for?
This trial is for adults over 18 with keratoconus or corneal ectasia, where the thinnest part of their cornea is more than 375 microns thick. They should have vision worse than 20/20 even with glasses or contacts. People can't join if they're allergic to study drugs, pregnant, nursing, have certain eye conditions that affect healing or gaze stability, very thin corneas (≤350 microns), or significant scarring in the treatment area.
What is being tested?
The trial tests a safer version of corneal collagen crosslinking called Transepithelial CXL using Riboflavin. Unlike traditional methods which remove surface cells and increase infection risk, this method keeps them intact for better safety and quicker recovery.
What are the potential side effects?
Transepithelial CXL may cause less discomfort post-operation compared to traditional methods due to non-removal of epithelium. However, potential side effects might include mild irritation, temporary visual disturbances and rare chances of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with keratoconus or corneal ectasia after surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had an eye condition that could cause future problems.
Select...
I do not have any conditions that prevent me from keeping my gaze steady.
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I have noticeable scarring on my cornea where I received CXL treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Maximum Keratometry
Secondary study objectives
Endothelial cell density
Manifest refraction
Visual Acuity

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Active Control
Group I: Riboflavin drops every minuteActive Control1 Intervention
Administration of riboflavin every 2 minutes for the duration of UV exposure.
Group II: Riboflavin drops every 2 minutesActive Control1 Intervention
Administration of riboflavin every 1 minute for the duration of UV exposure.

Find a Location

Who is running the clinical trial?

Cornea and Laser Eye InstituteLead Sponsor
9 Previous Clinical Trials
953 Total Patients Enrolled
9 Trials studying Keratoconus
953 Patients Enrolled for Keratoconus
Peter Hersh, MDPrincipal InvestigatorCornea and Laser Eye Institute
5 Previous Clinical Trials
457 Total Patients Enrolled
3 Trials studying Keratoconus
327 Patients Enrolled for Keratoconus

Media Library

Riboflavin (Crosslinking Agent) Clinical Trial Eligibility Overview. Trial Name: NCT01464268 — Phase 3
Keratoconus Research Study Groups: Riboflavin drops every minute, Riboflavin drops every 2 minutes
Keratoconus Clinical Trial 2023: Riboflavin Highlights & Side Effects. Trial Name: NCT01464268 — Phase 3
Riboflavin (Crosslinking Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01464268 — Phase 3
Keratoconus Patient Testimony for trial: Trial Name: NCT01464268 — Phase 3
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