Recruiting
Phase 3

Corneal Crosslinking

Sponsor:

Cornea and Laser Eye Institute

Code:

NCT04897503

Conditions

Keratoconus

Corneal Ectasia

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

Interventions

Riboflavin

Study Details

Brief summary:

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.

Conditions

Keratoconus

Corneal Ectasia

Study ID

NCT04897503

Start date

Apr 16, 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
  • 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

Exclusion Criteria:

  • 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

Study Design

Enrollment

170 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: CXL using Riboflavin/Dextran solution

Corneal collagen crosslinking using 0.1% riboflavin mixed with 20% dextran

active comparator: CXL usinng Riboflavin/Methylcellulose solution

Corneal collagen crosslinking using 0.1% riboflavin mixed with 1.0% hydroxypropylmethylcellulose ( HPMC)

Interventions

Riboflavin

Corneal epithelium removed followed by riboflavin drop administration (riboflavin/dextran -vs- riboflavin/methylcellulose) every 2 minutes for 30 minutes followed by UV light exposure with additional riboflavin administration every 2 minutes for 30 minutes. Subjects will be randomized to receive either the riboflavin/dextran solution or the riboflavin/HPMC solution.

Primary outcome measure

  • Maximum keratometry [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

BethAnn Furlong-Hibbert

1 201 692-9434bafhibbert@yahoo.com

Stacey Lazar

1 201 692-9434slazar@vision-institute.com

Locations

Cornea and Laser Eye Institue - Hersh Vision Group

Recruiting

Teaneck, New Jersey, United States, 07666

Contacts

BethAnn Furlong-Hibbert, BA

201-883-0505bfurlong-hibbert@vision-institute.com

Stacey Lazar, BS

201-883-0505slazar@vision-institute.com

Principal Investigator:

Peter S Hersh, 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
  • cornea
  • ultraviolet
  • 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.