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CXL-04 A Study of Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Primary Purpose

Keratoconus

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Theralight crosslinking and Riboflavin
Sponsored by
Cxlusa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Keratoconus focused on measuring keratoconus, cross-linking, Post-LASIK ectasia, Pellucid marginal degeneration, Forme fruste pellucid marginal degeneration, FFKC, Radial Keratotomy, Terrien's Marginal Degeneration

Eligibility Criteria

8 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 8 years of age or older

  2. Having at least one of the following conditions:

    • Keratoconus
    • Post-LASIK ectasia
    • Pellucid marginal degeneration
    • Forme fruste pellucid marginal degeneration
    • FFKC
    • History of Radial Keratotomy with fluctuating vision.
    • Terrien's Marginal Degeneration
  3. Signed written informed consent and/or assent
  4. Likely to complete all study visits
  5. Minimum corneal thickness of at least 250 microns measured by ultrasound or Pentacam for all indications other than Terrien's. For Terrien's, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment.

Exclusion Criteria:

  1. Severe corneal scarring that markedly affects vision
  2. Contraindications to any study medications or their components
  3. Pregnancy or breast feeding
  4. Active Herpes Corneal Disease

Sites / Locations

  • Center for Excellence in Eye Care
  • Stulting Research Center at Woolfson Eye Institute
  • TLC Laser Eye Center
  • Talamo Hatch Laser Eye Consultants, LLC
  • Cleveland Eye Clinic
  • TLC Laser Eye Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Theralight crosslinking and Riboflavin

Arm Description

ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using UVA light and the photo- mediator riboflavin

Outcomes

Primary Outcome Measures

Change in Best Spectacle Corrected Visual Acuity (BSCVA)

Secondary Outcome Measures

Change in Uncorrected Visual Acuity (UCVA)
Change in Corneal topography
Change in Manifest Refraction
Change in Keratometry on topography and Pentacam
Change in Wavefront Refraction and aberrations

Full Information

First Posted
September 27, 2013
Last Updated
October 10, 2018
Sponsor
Cxlusa
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1. Study Identification

Unique Protocol Identification Number
NCT01956474
Brief Title
CXL-04 A Study of Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
Official Title
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Terminated
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 3, 2017 (Actual)
Study Completion Date
February 3, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cxlusa

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin.
Detailed Description
This study will evaluate the results of Corneal Collagen Crosslinking (CXL) in patients with conditions that include Keratoconus, Pellucid Marginal degeneration, Post-LASIK ectasia, and patients with radial keratotomy who experience fluctuation in their vision. This is an outcomes study, all patients receive treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconus
Keywords
keratoconus, cross-linking, Post-LASIK ectasia, Pellucid marginal degeneration, Forme fruste pellucid marginal degeneration, FFKC, Radial Keratotomy, Terrien's Marginal Degeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1324 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Theralight crosslinking and Riboflavin
Arm Type
Other
Arm Description
ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) using UVA light and the photo- mediator riboflavin
Intervention Type
Other
Intervention Name(s)
Theralight crosslinking and Riboflavin
Intervention Description
Corneal Collagen cross linking with UV light and riboflavin
Primary Outcome Measure Information:
Title
Change in Best Spectacle Corrected Visual Acuity (BSCVA)
Time Frame
6-9 months
Secondary Outcome Measure Information:
Title
Change in Uncorrected Visual Acuity (UCVA)
Time Frame
6-9 months
Title
Change in Corneal topography
Time Frame
6-9 months
Title
Change in Manifest Refraction
Time Frame
6-9 months
Title
Change in Keratometry on topography and Pentacam
Time Frame
6-9 months
Title
Change in Wavefront Refraction and aberrations
Time Frame
6-9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 8 years of age or older Having at least one of the following conditions: Keratoconus Post-LASIK ectasia Pellucid marginal degeneration Forme fruste pellucid marginal degeneration FFKC History of Radial Keratotomy with fluctuating vision. Terrien's Marginal Degeneration Signed written informed consent and/or assent Likely to complete all study visits Minimum corneal thickness of at least 250 microns measured by ultrasound or Pentacam for all indications other than Terrien's. For Terrien's, the minimal corneal thickness should be consistent with the surgeon's best surgical judgment. Exclusion Criteria: Severe corneal scarring that markedly affects vision Contraindications to any study medications or their components Pregnancy or breast feeding Active Herpes Corneal Disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Trattler, MD
Organizational Affiliation
Cxlusa
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Excellence in Eye Care
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Stulting Research Center at Woolfson Eye Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
TLC Laser Eye Center
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Talamo Hatch Laser Eye Consultants, LLC
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Facility Name
Cleveland Eye Clinic
City
Brecksville
State/Province
Ohio
ZIP/Postal Code
44141
Country
United States
Facility Name
TLC Laser Eye Center
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States

12. IPD Sharing Statement

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CXL-04 A Study of Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

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