Recruiting
Phase 3

Accelerated Crosslinking

Sponsor:

Cornea and Laser Eye Institute

Code:

NCT05027295

Conditions

Keratoconus

Corneal Ectasia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

riboflavin ophthalmic solution

riboflavin ophthalmic solution

Study Details

Brief summary:

Corneal collagen crosslinking has been demonstrated as an effective method of reducing progression of both keratoconus and post-refractive corneal ectasia, as well as decreasing the steepness of the cornea in these pathologies.

Performing an accelerated CXL procedure with pulsed UVA light may increase the oxygenation of the cornea, which may improve the crosslinking efficacy.

Conditions

Keratoconus

Corneal Ectasia

Study ID

NCT05027295

Start date

Jul 30, 2021

Status verified date

Dec, 2022

Completion date

Jul, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 18 years of age or older having a diagnosis of keratoconus or corneal ectasia after corneal refractive surgery
  • Presence of central or inferior corneal 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 corneal erosion syndrome, corneal melt, corneal dystrophy, etc.
2. Clinically significant scarring in the CXL treatment zone
  • A history of chemical injury or delayed 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 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: Continuous UVA

Riboflavin administration one drop every two minutes with administration of 12mW/cm2 of continuous UVA light for 7.5 minute exposure time

active comparator: Pulsed UVA

Riboflavin administration one drop every two minutes with administration of 12mW/cm2 of pulsed UVA light for 15 minute exposure time

Interventions

riboflavin ophthalmic solution

Administration of riboflavin one drop every 2 minutes during administration of continuous UVA light for 7.5 minutes.

riboflavin ophthalmic solution

Administration of riboflavin one drop every 2 minutes during administration of pulsed UVA light for 15 minutes

Primary outcome measure

  • Maximum keratometry [ Time Frame: 6 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 Furlong-Hibbert

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

Stacey Lazar

(201) 694-9434slazar@vision-institute.com

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.