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Procedure

Epi-On CXL for Keratoconus (CXL Trial)

Phase 3

Waitlist Available

Led By Penny A Asbell, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

CXL Trial Summary

This prospective, randomized study is being conducted to evaluate the safety and effectiveness of corneal cross-linking (CXL) in patients with keratoconus or post-refractive ectasia (post-LASIK or PRK) utilizing two techniques: the "standard" Epi-Off technique or an Epi-On technique that utilizes iontophoresis (I-CXL) to deliver the riboflavin to the cornea without need for removal of the corneal epithelium. Patients will be randomized to receive CXL treatment with either the Epi-On or Epi-Off technique.

Eligible Conditions

Keratoconus
Aneurysm

CXL Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in Kmax

Secondary outcome measures

Change in BCVA

Change in astigmatism

Change in cylinder

+5 more

CXL Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Epi-On CXLExperimental Treatment1 Intervention

The IONTOPHOR CXL iontophoresis applicator and the associated blepharostat will be placed onto the cornea to be treated. The applicator will be secured to the cornea and filled with Ricrolin+ which as been aspirated from the bottle using a syringe with a needle. The generator will be switched on and set to 1 mA for 5 minutes. The generator will then be disconnected and the applicator will be removed from the cornea.

Group II: Epi-Off CXLActive Control1 Intervention

Using topical anesthesia (proparacaine), the surgeon will create a complete corneal abrasion to facilitate riboflavin diffusion into the cornea. The epithelium will be removed by gently brushing the cornea with a scalpel. A corneal abrasion diameter of ~9mm is recommended, which may be adjusted as needed at the discretion of the investigator to accommodate individual eye geometry. Ultrasound corneal pachymetry should be performed before dis-epithelialization and after dis- epithelialization. Local anesthetics will be administered as needed to maintain patient comfort during the CXL procedure.

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Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

863 Previous Clinical Trials

525,606 Total Patients Enrolled

Penny A Asbell, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai

1 Previous Clinical Trials

535 Total Patients Enrolled

Frequently Asked Questions

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

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?

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

Recent research and studies

clinicaltrials.govStudy

Safety and Effectiveness of Corneal Crosslinking (CXL): Keratoconus and Post-Refractive Ectasia

Penny Asbell 2016. "Safety and Effectiveness of Corneal Crosslinking (CXL): Keratoconus and Post-Refractive Ectasia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03080077.

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