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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial is testing whether a new crosslinking technique can better maintain corneal thickness, potentially leading to better results.

Who is the study for?

This trial is for adults over 18 with progressive keratoconus or corneal ectasia, whose vision isn't fully corrected to 20/20 with lenses. Their cornea must be thicker than 300 microns. It's not for those sensitive to the study drugs, have certain eye conditions, are pregnant/lactating, can't keep a steady gaze during treatment, or have other risks as assessed by the investigator.Check my eligibility

What is being tested?

The trial tests two types of corneal collagen crosslinking (CXL) treatments using Hypotonic Riboflavin and Riboflavin/Dextran in patients with keratoconus or ectasia. The goal is to see if maintaining corneal thickness improves the consistency and predictability of CXL outcomes.See study design

What are the potential side effects?

Potential side effects may include changes in vision, discomfort in the eye, swelling or inflammation of the cornea, infection risk increase due to epithelial healing delay after treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

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

Corneal thickness

Secondary outcome measures

Endothelial Cell Density

Manifest Refraction

Maximum Keratometry

+1 more

Trial Design

2Treatment groups

Active Control

Group I: Riboflavin/dextranActive Control1 Intervention

Administration of Riboflavin/dextran every 2 minutes for the duration of UV exposure.

Group II: Hypotonic RiboflavinActive Control1 Intervention

Administration of hypotonic riboflavin every 2 minutes for the duration of UV exposure.

0 / 1Eligibility 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

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

Corneal Collagen Crosslinking (Other) Clinical Trial Eligibility Overview. Trial Name: NCT01152541 — Phase 3

Keratoconus Research Study Groups: Riboflavin/dextran, Hypotonic Riboflavin

Keratoconus Clinical Trial 2023: Corneal Collagen Crosslinking Highlights & Side Effects. Trial Name: NCT01152541 — Phase 3

Corneal Collagen Crosslinking (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01152541 — 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 other instances where Hypotonic Riboflavin has been tested in a controlled setting?

"There are presently 21 ongoing studies for Hypotonic Riboflavin, with the majority of them being in Phase 3. Out of the 47 total clinical trial locations for this medication, most of them are situated in Teaneck, New jersey."

Answered by AI

Are there any current openings for participants in this clinical trial?

"Unfortunately, this trial is not currently looking for new participants. It was originally posted on 6/1/2010 but the most recent update was on 3/7/2022. However, there are 81 trials actively enrolling patients with keratoconus and 21 studies for Hypotonic Riboflavin that are admitting new patients if you explore other options."

Answered by AI

What are the primary issues that Hypotonic Riboflavin addresses?

"Hypotonic Riboflavin is often used to replenish vitamin deficiencies. However, it has also been shown to ameliorate symptoms of dry eyes, pulmonary embolism, and fluorophotometry."

Answered by AI

How many people are consenting to participate in this experiment?

"Recruitment for this particular trial has ceased. The study was originally advertised on 6/1/2010 and updated as recently as 3/7/2022. For individuals searching for other studies, there are 81 trials admitting participants with keratoconus and 21 studies for Hypotonic Riboflavin that active recruiting right now."

Answered by AI

Has the FDA given their seal of approval to Hypotonic Riboflavin?

"There is some evidence that Hypotonic Riboflavin is effective, as this is a Phase 3 trial. Furthermore, there is ample safety data from multiple sources, so it received a score of 3."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Corneal Collagen Crosslinking for Progressive Keratoconus and Ectasia Using Riboflavin/Dextran and Hypotonic Riboflavin

2010. "Corneal Collagen Crosslinking for Progressive Keratoconus and Ectasia Using Riboflavin/Dextran and Hypotonic Riboflavin". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01152541.

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