RECRUITING

Corneal Collagen Crosslinking for Keratoconus and Ectasia Using Riboflavin/Dextran or Riboflavin/Methylcellulose

Conditions

Keratoconus Corneal Ectasia collagen crosslinking riboflavin cornea ultraviolet crosslinking corneal crosslinking

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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

This study is being conducted to evaluate the safety and efficacy of isotonic riboflavin for corneal collagen crosslinking for keratoconus and corneal ectasia. will determine the safety and efficacy of corneal collagen crosslinking (CXL) performed with two different riboflavin formulations for reducing corneal curvature.

Official Title

Randomized Study of Safety and Effectiveness of Corneal Collagen Crosslinking Using Riboflavin/Dextran or Riboflavin/Methylcellulose

Quick Facts

Study Start:2021-04-16

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04897503

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 Criteria	Exclusion Criteria
* 12 years of age or older * Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery * 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 lens 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 less than or equal to 300 microns 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: History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) Clinically significant corneal scarring 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

Inclusion Criteria

Exclusion Criteria

* 12 years of age or older
* Having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery
* 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 lens 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 less than or equal to 300 microns 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: History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.) Clinically significant corneal scarring 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

Contacts and Locations

Study Contact

BethAnn Furlong-Hibbert

CONTACT

1 201 692-9434

bafhibbert@yahoo.com

Stacey Lazar

CONTACT

1 201 692-9434

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 Institue - 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 Date2021-04-16

Study Completion Date2025-12

Study Record Updates

Study Start Date2021-04-16

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

keratoconus
corneal ectasia
collagen crosslinking
riboflavin
cornea
ultraviolet
crosslinking
corneal crosslinking

Additional Relevant MeSH Terms

Keratoconus
Corneal Ectasia