search
Back to results

Corneal Collagen Cross-linking for Progressive Keratoconus (CXL)

Primary Purpose

Progressive Keratoconus

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
riboflavin ophthalmic solution
UVA Irradiation
Sponsored by
Glaukos Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Progressive Keratoconus focused on measuring keratoconus, cross-linking, riboflavin, UVA light, cornea

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of keratoconus
  • Documented progression over previous 24 months
  • Decreased BSCVA
  • Must complete all study visits

Exclusion Criteria:

  • Prior corneal surgery or Intacs
  • History of delayed wound healing

Sites / Locations

  • Shiley Eye Center
  • Gordon -Weiss Vision Institute
  • Center for Excellence in Eye Care
  • Price Vision Group
  • Durrie Vision
  • Wilmer Eye Institute at Johns Hopkins University
  • Minnesota Eye Consultants
  • Cornea & Laser Eye Institute; Hersh Vision Group
  • Edward Harkness Eye Institute at Columbia University Medical Center
  • Ophthalmic Consultants of Long Island

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Corneal Collagen Cross-linking (CXL) Treatment Group

Control Group

Arm Description

riboflavin ophthalmic solution and UVA irradiation

riboflavin ophthalmic solution without UVA irradiation.

Outcomes

Primary Outcome Measures

Mean Change From Baseline in Maximum Keratometry (Kmax)
The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.

Secondary Outcome Measures

Full Information

First Posted
March 28, 2008
Last Updated
April 22, 2021
Sponsor
Glaukos Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT00647699
Brief Title
Corneal Collagen Cross-linking for Progressive Keratoconus
Acronym
CXL
Official Title
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking in Eyes With Progressive Keratoconus
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 2007 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Glaukos Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Prospective, randomized multicenter study to determine the safety and effectiveness of performing cornea collagen cross-linking (CXL) using riboflavin and UVA light in eyes with progressive keratoconus.
Detailed Description
This was a sham controlled study for the first three months. Patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye. The patients were evaluated at 1, 3, 6, and 12 months. At month 3 or later patients had the option of receiving CXL treatment in both the sham and non-study eye.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Keratoconus
Keywords
keratoconus, cross-linking, riboflavin, UVA light, cornea

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
147 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Corneal Collagen Cross-linking (CXL) Treatment Group
Arm Type
Active Comparator
Arm Description
riboflavin ophthalmic solution and UVA irradiation
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
riboflavin ophthalmic solution without UVA irradiation.
Intervention Type
Drug
Intervention Name(s)
riboflavin ophthalmic solution
Intervention Description
riboflavin 0.1% ophthalmic solution (approximately 32 drops, or 1.6 mL)
Intervention Type
Device
Intervention Name(s)
UVA Irradiation
Other Intervention Name(s)
UV-X Illumination System
Intervention Description
UVA light (365 nm at an irradiance of 3 mW/cm2) for 30 minutes
Primary Outcome Measure Information:
Title
Mean Change From Baseline in Maximum Keratometry (Kmax)
Description
The primary efficacy parameter was corneal curvature, as measured by maximum keratometry (Kmax) in the study eyes. Study success was defined as a difference of ≥1 D in the mean change in Kmax from baseline to 12 months between the CXL group and control group. Keratometry was measured manually and by pentacam.
Time Frame
baseline,12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of keratoconus Documented progression over previous 24 months Decreased BSCVA Must complete all study visits Exclusion Criteria: Prior corneal surgery or Intacs History of delayed wound healing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Hersh, MD
Organizational Affiliation
Cornea and Laser Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shiley Eye Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Gordon -Weiss Vision Institute
City
San Diego
State/Province
California
ZIP/Postal Code
91222
Country
United States
Facility Name
Center for Excellence in Eye Care
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Price Vision Group
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Durrie Vision
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66211
Country
United States
Facility Name
Wilmer Eye Institute at Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Minnesota Eye Consultants
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Cornea & Laser Eye Institute; Hersh Vision Group
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
Edward Harkness Eye Institute at Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Rockville Centre
State/Province
New York
ZIP/Postal Code
11570
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
22692521
Citation
Greenstein SA, Fry KL, Hersh PS. Effect of topographic cone location on outcomes of corneal collagen cross-linking for keratoconus and corneal ectasia. J Refract Surg. 2012 Jun;28(6):397-405. doi: 10.3928/1081597X-20120518-02.
Results Reference
derived

Learn more about this trial

Corneal Collagen Cross-linking for Progressive Keratoconus

We'll reach out to this number within 24 hrs