RECRUITING

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

Talk to us

Conditions

KeratoconusCorneal Ectasiacollagen crosslinkingriboflavincrosslinkingcorneal crosslinking

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2021-06-02
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04905108

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.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 12 years of age or older
  2. * Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery (e.g., LASIK, photorefractive keratectomy \[PRK\])
  3. * Presence of central or inferior steepening on the Pentacam map
  4. * Axial topography consistent with keratoconus or post-surgical corneal ectasia
  5. * Contact lens wearers only: Removal of contact lenses for the required period of 1 week prior to the screening refraction
  6. * Signed written informed consent
  7. * Willingness and ability to comply with schedule for follow-up visits
  1. * Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme
  2. * Corneal pachymetry measuring 300 microns or less at the thinnest point measured by Pentacam in the eye(s) to be treated
  3. * Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications, for example:
  4. 1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)
  5. 2. Clinically significant corneal scaring in the CXL treatment zone
  6. * A history of chemical injury or delayed epithelial healing in the eye(s) to be treated
  7. * Pregnancy (including plan to become pregnant) or lactation during the course of the study
  8. * A known sensitivity to study medications
  9. * Patients with nystagmus or any other condition that would prevent a steady gaze during the CXL treatment or other diagnostic tests
  10. * Patients with a current condition that,in the investigator's opinion, would interfere with or prolong epithelial healing

Contacts and Locations

Study Contact

BethAnn Furlong-HIbbert
CONTACT
(201) 692-9434
bfurlong-hibbert@vision-institute.com
Stacey Lazar
CONTACT
(201) 692-9434
slazar@vision-institute.com

Principal Investigator

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 Locations (Sites)

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

Collaborators and Investigators

Sponsor: 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

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 Registration Dates

Study Start Date2021-06-02
Study Completion Date2025-12

Study Record Updates

Study Start Date2021-06-02
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • keratoconus
  • corneal ectasia
  • collagen crosslinking
  • riboflavin
  • crosslinking
  • corneal crosslinking

Additional Relevant MeSH Terms

  • Keratoconus
  • Corneal Ectasia