Recruiting
Phase 3

Corneal Crosslinking

Sponsor:

Cornea and Laser Eye Institute

Code:

NCT04905108

Conditions

Keratoconus

Corneal Ectasia

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

Interventions

Riboflavin

Riboflavin

Study Details

Brief summary:

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

Study ID

NCT04905108

Start date

Jun 2, 2021

Status verified date

Dec, 2022

Completion date

Dec, 2025

Anticipated

Primary completion date

Jun, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

Inclusion 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

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 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

Study Design

Enrollment

160 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Riboflavin drop every 2 minutes

Administration of one drop of Riboflavin every 2 minutes during UV exposure

active comparator: Riboflavin drop every 10 minutes

Administration of one drop of Riboflavin every 10 minutes during UV exposure

Interventions

Riboflavin

Administration of riboflavin one drop every 2 minutes during UVA exposure

Riboflavin

Administration of riboflavin one drop every 10 minutes during UVA exposure

Primary outcome measure

  • Maximum keratometry [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

BethAnn Furlong-HIbbert

(201) 692-9434bfurlong-hibbert@vision-institute.com

Stacey Lazar

(201) 692-9434slazar@vision-institute.com

Locations

Cornea and Laser Eye Institute, Hersh Vision Group

Recruiting

Teaneck, New Jersey, United States, 07666

Contacts

BethAnn Hibbert

201-692-9434bfurlong-hibbert@vision-institute.com

Stacey Lazar

201 692-434slazar@vision-institute.om

Principal Investigator:

Steven A Greenstein, MD

More Information

Sponsor

Cornea and Laser Eye Institute

Last update posted

Jan 4, 2023

Last verified

Dec, 2022

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cornea and Laser Eye Institute on 2023-01-04.