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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Maximum Keratometry

Secondary outcome measures

Endothelial cell density

Manifest refraction

Visual Acuity

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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Cornea and Laser Eye InstituteLead Sponsor

9 Previous Clinical Trials

953 Total Patients Enrolled

Peter Hersh, MDPrincipal InvestigatorCornea and Laser Eye Institute

5 Previous Clinical Trials

457 Total Patients Enrolled

Media Library

Riboflavin (Crosslinking Agent) Clinical Trial Eligibility Overview. Trial Name: NCT01464268 — Phase 3

Corneal Ectasia Research Study Groups: Riboflavin drops every minute, Riboflavin drops every 2 minutes

Corneal Ectasia 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

Corneal Ectasia Patient Testimony for trial: Trial Name: NCT01464268 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available vacancies for subjects in this research?

"Unfortunately, this particular study is not recruiting patients at the moment. The trial was initially posted on November 1st, 2011 and was last updated on March 7th, 2022. Although this study is not looking for patients, there are many other trials with open recruitment at the moment."

Answered by AI

Are there other scientific papers which suggest that Riboflavin is effective when administered every 2 minutes?

"Out of the 20 ongoing clinical trials for Riboflavin drops every 2 minutes, 11 are in Phase 3. The vast majority of these studies are taking place in San Francisco; however, there are a total of 47 research centres running these trials across the United States."

Answered by AI

What is the standard dosage of Riboflavin for treating migraines?

"Riboflavin, taken every two minutes via drops, is used to treat various issues like nutritional deficiencies, joint pain, and vitamin insufficiencies."

Answered by AI

Is it harmful to use Riboflavin every 2 minutes?

"There is some efficacy data available for Riboflavin drops every 2 minutes, as this is a Phase 3 trial. Furthermore, there is robust safety data because there have been multiple rounds of testing. Therefore, we have rated the safety as a 3."

Answered by AI

Who else is applying?

What state do they live in?

Missouri

What portion of applicants met pre-screening criteria?

Did not meet criteria

Met criteria

How many prior treatments have patients received?

What site did they apply to?

Cornea and Laser Eye Institute

Why did patients apply to this trial?

I have progressive Keratoconus and received corneal cross linking in my left eye. Upon further testing I have been referred to treat my right eye. Expense is a concern. I want to help others with my condition to prevent further issues and prevent a corneal transplant in my future.

PatientReceived no prior treatments