Accelerated Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Pulse or Continuous UV-A Light

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

A Randomized Study to Evaluate the Safety and Efficacy of Corneal Collagen Crosslinking Performed With Continuous vs Pulsed UVA Light for Reducing Corneal Curvature in Eyes With Keratoconus and Post-refractive Corneal Ectasia

Corneal collagen crosslinking has been demonstrated as an effective method of reducing progression of both keratoconus and post-refractive corneal ectasia, as well as decreasing the steepness of the cornea in these pathologies.

Performing an accelerated CXL procedure with pulsed UVA light may increase the oxygenation of the cornea, which may improve the crosslinking efficacy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, single-site study to analyze the use of continuous vs pulsed UVA light after removal of the epithelium for the collagen crosslinking procedure for keratoconus and post-refractive corneal ectasia. In the standard crosslinking treatment, the cornea is treated with a continuous UVA light treatment with a power of 3mW/cm2 for 30 minutes. CXL treatment can potentially be performed in a shorter period of time by increasing the power of the UVA light and decreasing the exposure time, while maintaining the same total energy delivered to the cornea. This study will compare the efficacy and safety of accelerated crosslinking using either a continuous or pulsed UVA treatment. One group will be randomized to be treated with 12mW/cm2 of continuous UVA light treatment for 7.5 minutes and the other group will be treated with 12mW/cm2 of pulsed UVA light treatment for 15 minutes.

The primary efficacy parameter that will be evaluated over time is maximum keratometry (Kmax) in the randomized eyes for each treatment group. The secondary efficacy parameter is to determine if the two treatment groups are equivalent in their mean Kmax change at 6 months after treatment compared with baseline.

Study Type

Interventional

Enrollment (Anticipated)

170

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 years of age or older having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery
  • Presence of central or inferior corneal 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 corneal erosion syndrome, corneal melt, corneal dystrophy, etc.
    2. Clinically significant scarring in the CXL treatment zone
  • A history of chemical injury or delayed 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 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: Continuous UVA
Riboflavin administration one drop every two minutes with administration of 12mW/cm2 of continuous UVA light for 7.5 minute exposure time
Drug: riboflavin ophthalmic solution
Administration of riboflavin one drop every 2 minutes during administration of continuous UVA light for 7.5 minutes.
Drug: riboflavin ophthalmic solution
Administration of riboflavin one drop every 2 minutes during administration of pulsed UVA light for 15 minutes
Active Comparator: Pulsed UVA
Riboflavin administration one drop every two minutes with administration of 12mW/cm2 of pulsed UVA light for 15 minute exposure time
Drug: riboflavin ophthalmic solution
Administration of riboflavin one drop every 2 minutes during administration of continuous UVA light for 7.5 minutes.
Drug: riboflavin ophthalmic solution
Administration of riboflavin one drop every 2 minutes during administration of pulsed UVA light for 15 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum keratometry
Time Frame: 6 months
The change in maximum keratometry (Kmax) from baseline will be evaluated at 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean keratometry
Time Frame: 6 months
Determine whether the two treatment groups are equivalent in their mean keratometry (meanK) change at 6 months post treatment compared with baseline.
6 months

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

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)

July 30, 2021

Primary Completion (Anticipated)

July 1, 2025

Study Completion (Anticipated)

July 1, 2025

Study Registration Dates

First Submitted

August 24, 2021

First Submitted That Met QC Criteria

August 24, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

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

  • ACCEL-CXL-001

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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