Transepithelial (Epi-on) Corneal Collagen Crosslinking to Treat Keratoconus and Corneal Ectasia

December 30, 2022 updated by: Cornea and Laser Eye Institute

Randomized Study of Safety and Effectiveness of Corneal Collagen Crosslinking Using Two Different Riboflavin Administration Protocols

Corneal collagen crosslinking (CXL) has been demonstrated as an effective method of reducing progression of both keratoconus and corneal ectasia after surgery, as well as possibly decreasing the steepness of the cornea in these pathologies. Transepithelial crosslinking in which the epithelium is not removed has been proposed to offer a number of advantages over traditional crosslinking including an increased safety profile by reducing the risk for infection and scarring, faster visual recovery and improved patient comfort in the early postoperative healing period.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of this randomized study is to investigate the difference between two regimens of transepithelial crosslinking. The study will compare two riboflavin dosing regimens during the crosslinking procedure. The primary objective of this study is to evaluate the safety and efficacy of transepithelial corneal collagen crosslinking performed with two different riboflavin administration protocols during the UVA portion of the procedure. Safety and efficacy outcomes will then be compared between the treatment groups. In particular, the two groups will be compared with regard to their efficacy in reducing corneal curvature. Secondary outcomes will include visual acuity. Safety assessments will include a tabulation of adverse events, patient symptoms, loss of visual acuity, changes in endothelial cell density, and slit lamp examination.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Recruiting
        • Cornea and Laser Eye Institute, Hersh Vision Group
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Peter S Hersh, MD
        • Principal Investigator:
          • Steven A Greenstein, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 12 years of age or older
  • Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery (e.g., LASIK, photorefractive keratectomy [PRK])
  • Presence of central or inferior steepening on the Pentacam map
  • Axial topography consistent with keratoconus or post-surgical corneal ectasia
  • Contact lens wearers only: Removal of contact lenses for the required period of 1 week prior to the screening refraction
  • Signed written informed consent
  • Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

  • Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme
  • Corneal pachymetry measuring 300 microns or less at the thinnest point measured by Pentacam in the eye(s) to be treated

  • Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:

    1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
    2. Clinically significant corneal scaring in the CXL treatment zone
  • A history of chemical injury or delayed epithelial healing in the eye(s) to be treated
  • Pregnancy (including plan to become pregnant) or lactation during the course of the study
  • A known sensitivity to study medications
  • Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests
  • Patients with a current condition that,in the investigator's opinion, would interfere with or prolong epithelial healing

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Riboflavin drop every 2 minutes
Administration of one drop of Riboflavin every 2 minutes during UV exposure
Drug: Riboflavin
Administration of riboflavin one drop every 2 minutes during UVA exposure
Drug: Riboflavin
Administration of riboflavin one drop every 10 minutes during UVA exposure
Active Comparator: Riboflavin drop every 10 minutes
Administration of one drop of Riboflavin every 10 minutes during UV exposure
Drug: Riboflavin
Administration of riboflavin one drop every 2 minutes during UVA exposure
Drug: Riboflavin
Administration of riboflavin one drop every 10 minutes during UVA exposure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum keratometry
Time Frame: 12 months
The change in maximum keratometry (Kmax) from baseline will be evaluated at 12 months for all eyes randomized in group 1 and group 2.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean keratometry
Time Frame: 1 year
The change in mean keratometry (Mean K) from baseline will be evaluated at 12 months for all eyes randomized in group 1 and group 2.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cornea and Laser Eye Institute

Investigators

  • Study Director: Peter S Hersh, MD, Cornea and Laser Eye Institute - Hersh Vision Group
  • Principal Investigator: Steven A Greenstein, MD, Cornea and Laser Eye Institute - Hersh Vision Group

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2021

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

May 24, 2021

First Submitted That Met QC Criteria

May 24, 2021

First Posted (Actual)

May 27, 2021

Study Record Updates

Last Update Posted (Estimate)

January 4, 2023

Last Update Submitted That Met QC Criteria

December 30, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TE-CXL-002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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