NCT05027295

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
170

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2021

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 30, 2021

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

January 4, 2023

Status Verified

December 1, 2022

Enrollment Period

3.9 years

First QC Date

August 24, 2021

Last Update Submit

December 30, 2022

Conditions

KeratoconusCorneal Ectasia

Keywords

keratoconuscorneal ectasiacollagen crosslinkingriboflavincrosslinkingcorneal crosslinking

Outcome Measures

Primary Outcomes (1)

  • Maximum keratometry

    The change in maximum keratometry (Kmax) from baseline will be evaluated at 6 months

    6 months

Secondary Outcomes (1)

  • Mean keratometry

    6 months

Study Arms (2)

Continuous UVA

ACTIVE COMPARATOR

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

Drug: riboflavin ophthalmic solution

Pulsed UVA

ACTIVE COMPARATOR

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

Drug: riboflavin ophthalmic solution

Interventions

riboflavin ophthalmic solutionDRUG

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

Continuous UVA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • History of corneal disease (e.g. herpes simplex, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal melt, corneal dystrophy, etc.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cornea and Laser Eye Institute, Hersh Vision Group

Teaneck, New Jersey, 07666, United States

RECRUITING

MeSH Terms

Conditions

Keratoconus

Condition Hierarchy (Ancestors)

Corneal DiseasesEye Diseases

Study Officials

  • Peter S Hersh, MD

    Cornea and Laser Eye Institute, Hersh Vision Group

    STUDY DIRECTOR

Central Study Contacts

BethAnn Furlong-Hibbert

CONTACT

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

Stacey Lazar

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 24, 2021

First Posted

August 30, 2021

Study Start

July 30, 2021

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

January 4, 2023

Record last verified: 2022-12

Locations

US(1)