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

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Brief Title

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

Official Title

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

Brief Summary

      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.
    

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 Phase

Phase 3

Study Type

Interventional


Primary Outcome

Maximum keratometry

Secondary Outcome

 Mean keratometry

Condition

Keratoconus

Intervention

riboflavin ophthalmic solution

Study Arms / Comparison Groups

 Continuous UVA
Description:  Riboflavin administration one drop every two minutes with administration of 12mW/cm2 of continuous UVA light for 7.5 minute exposure time

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

170

Start Date

July 30, 2021

Completion Date

July 2025

Primary Completion Date

July 2023

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Peter S Hersh, MD, (201) 692-9434, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT05027295

Organization ID

ACCEL-CXL-001


Responsible Party

Sponsor

Study Sponsor

Cornea and Laser Eye Institute


Study Sponsor

Peter S Hersh, MD, Study Director, Cornea and Laser Eye Institute, Hersh Vision Group


Verification Date

August 2021