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

Description

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.

Conditions

Keratoconus, Corneal Ectasia

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Keratoconus
Intervention / Treatment

-

Contacts and Locations

Teaneck

Cornea and Laser Eye Institute, Hersh Vision Group, Teaneck, New Jersey, United States, 07666

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Cornea and Laser Eye Institute,

Peter S Hersh, MD, STUDY_DIRECTOR, Cornea and Laser Eye Institute - Hersh Vision Group

Steven A Greenstein, MD, PRINCIPAL_INVESTIGATOR, Cornea and Laser Eye Institute - Hersh Vision Group

Study Record Dates

2025-12