Collagen Cross-Linking With Ultraviolet-A in Asymmetric Corneas

December 15, 2021 updated by: Cxlusa
This study will assess changes in visual acuity and corneal symmetry after corneal collagen cross-linking (CXL) of asymmetric corneas.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

This study will evaluate the results of Corneal Collagen Crosslinking (CXL) in patients with conditions that include keratoconus, forme fruste keratoconus, post-LASIK ectasia, pellucid marginal degeneration, forme fruste pellucid marginal degeneration, diurnal fluctuation post-radial keratotomy, or Terrien's marginal degeneration. This is an outcomes study, all patients receive treatment.

Study Type

Interventional

Enrollment (Actual)

2228

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Schwartz Laser Eye Center
    • California
      • San Francisco, California, United States, 94115
        • Goodman Eye Center
    • Colorado
      • Littleton, Colorado, United States, 80120-4508
        • Cornea Consultants of Colorado
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Woolfson Eye Institute
    • Illinois
      • Chicago, Illinois, United States, 60035
        • Chicago Cornea Consultants
      • Hoffman Estates, Illinois, United States, 60169
        • Chicago Cornea Consultants, Ltd.
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Ophthalmology Associates
    • Ohio
      • Brecksville, Ohio, United States, 44141
        • Cleveland Eye Clinic
    • Texas
      • Dallas, Texas, United States, 75231
        • Cornea Associates of Texas

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.

Eligibility Criteria

Ages Eligible for Study

8 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A diagnosis of at least one of the following conditions:

    1. Keratoconus
    2. Forme fruste keratoconus
    3. Post-LASIK ectasia
    4. Pellucid marginal degeneration
    5. Forme fruste pellucid marginal degeneration
    6. Diurnal fluctuation post-radial keratotomy
    7. Terrien's marginal degeneration

Exclusion Criteria:

  1. Corneal thickness < 375 microns measured by ultrasound or Pentacam.
  2. Contraindications or hypersensitivities to any study medications or their components.
  3. Pregnancy or breastfeeding.
  4. Any history of herpes simplex corneal disease in an eye to be treated.
  5. Nystagmus or any other condition that would, in the judgement of the investigator, prevent a steady gaze during the treatment.
  6. Inability to cooperate with diagnostic tests.
  7. Enrollment in another ophthalmic clinical trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.
Combination product: CXLO Corneal Strengthening Solution and UVA Illumination Device
CXLO Corneal Strengthening Solution
Active Comparator: Group 2
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 6 mW/cm2 cycled On/Off at 15 second intervals for 20 minutes.
Combination product: CXLO Corneal Strengthening Solution and UVA Illumination Device
CXLO Corneal Strengthening Solution
Active Comparator: Group 3
Ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using CXLO Corneal Strengthening Solution and a UVA irradiance of 4 mW/cm2 cycled On/Off at 15 second intervals for 30 minutes.
Combination product: CXLO Corneal Strengthening Solution and UVA Illumination Device
CXLO Corneal Strengthening Solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Corrected Distance Visual Acuity (CDVA)
Time Frame: Baseline and 6 and 12 months
Changes in CDVA are reported as the value at 6 and 12 months minus the value at baseline
Baseline and 6 and 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Uncorrected Distance Visual Acuity (UCVA)
Time Frame: Baseline and 6 and 12 months
Changes in UCVA are reported as the value at 6 and 12 months minus the value at baseline
Baseline and 6 and 12 months
Change From Baseline in Maximum Keratometry (KMax)
Time Frame: Baseline and 6 and 12 months
Kmax is the maximum value of corneal curvature in Diopters. Changes in Kmax are reported as the value at 6 and 12 months minus the value at baseline.
Baseline and 6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cxlusa

Investigators

  • Principal Investigator: Gregg J Berdy, MD, FACS, Ophthalmology Associates, St. Louis, MO

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

December 21, 2016

Primary Completion (Actual)

December 27, 2020

Study Completion (Actual)

December 27, 2020

Study Registration Dates

First Submitted

January 20, 2017

First Submitted That Met QC Criteria

January 20, 2017

First Posted (Estimate)

January 24, 2017

Study Record Updates

Last Update Posted (Actual)

January 12, 2022

Last Update Submitted That Met QC Criteria

December 15, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CXL-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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