Safety & Efficacy of Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery
- Conditions
- KeratoconusCorneal Ectasia
- Interventions
- Device: KXL System (45 mW/cm2)Device: KXL System (30 mW/cm2)Device: KXL System (15 mW/cm2)
- Registration Number
- NCT01459679
- Lead Sponsor
- American-European Congress of Ophthalmic Surgery
- Brief Summary
The objectives of this study are to evaluate and compare the safety and efficacy of three treatment regimens for corneal collagen cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System in impeding the progression of, and/or reducing maximum corneal curvature.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1721
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VibeX Treatment Group C riboflavin ophthalmic solution Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 2 minutes and 40 seconds VibeX Treatment Group C KXL System (45 mW/cm2) Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 2 minutes and 40 seconds VibeX Treatment Group A riboflavin ophthalmic solution Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 8 minutes VibeX Treatment Group B KXL System (30 mW/cm2) Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 4 minutes VibeX Treatment Group B riboflavin ophthalmic solution Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 4 minutes VibeX Treatment Group A KXL System (15 mW/cm2) Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 8 minutes
- Primary Outcome Measures
Name Time Method Mean change in maximum corneal curvature (Kmax) from baseline Month 6 or 12
- Secondary Outcome Measures
Name Time Method Comparison of treatment groups within each treatment indication Month 6 and 12
Trial Locations
- Locations (83)
Herschel Lasik
🇺🇸Orlando, Florida, United States
Advanced Vision Care
🇺🇸Los Angeles, California, United States
Eye Surgical Associates
🇺🇸Lincoln, Nebraska, United States
Loden Vision Center
🇺🇸Goodlettsville, Tennessee, United States
Chu Vision Institute
🇺🇸Bloomington, Minnesota, United States
Mile High Corneal Specialists, PC
🇺🇸Denver, Colorado, United States
Grene Vision Group
🇺🇸Wichita, Kansas, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Barnet Dulaney Perkins Eye Center
🇺🇸Phoenix, Arizona, United States
University of Utah Dept. of Ophthalmology & Visual Sciences
🇺🇸Salt Lake City, Utah, United States
Manchester Ophthalmology
🇺🇸Manchester, Connecticut, United States
Berkeley Eye Center
🇺🇸Houston, Texas, United States
Ophthalmic Consultants of Boston
🇺🇸Waltham, Massachusetts, United States
Princeton Eye Group
🇺🇸Princeton, New Jersey, United States
Eye Surgery and Laser Center
🇺🇸Madison, Mississippi, United States
Lilia Rivera
🇵🇷San Juan, Puerto Rico
University of Michigan
🇺🇸Ann Arbor, Michigan, United States
John Parker
🇺🇸Birmingham, Alabama, United States
Braverman Eye Center
🇺🇸Hallandale Beach, Florida, United States
Eyecare Medical Group
🇺🇸Portland, Maine, United States
Solomon Eye Physicians and Surgeons
🇺🇸Bowie, Maryland, United States
Michigan Cornea Consultants
🇺🇸Southfield, Michigan, United States
Boston Eye Group
🇺🇸Brookline, Massachusetts, United States
Kugler Vision, PC
🇺🇸Omaha, Nebraska, United States
Dean McGee Eye Institute
🇺🇸Oklahoma City, Oklahoma, United States
Ramapo Ophthalmology Associates, LLP
🇺🇸Pomona, New York, United States
North Shore LIJ Health Systems
🇺🇸Great Neck, New York, United States
Bagan Strinden Vision
🇺🇸Fargo, North Dakota, United States
Devers Eye Institute
🇺🇸Portland, Oregon, United States
Northeastern Eye Institute
🇺🇸Scranton, Pennsylvania, United States
Wang Vision Institute
🇺🇸Nashville, Tennessee, United States
Dean Foundation for Health, Research and Education, Inc.
🇺🇸Madison, Wisconsin, United States
Vance Thompson Vision
🇺🇸Sioux Falls, South Dakota, United States
Hoopes Vision
🇺🇸Draper, Utah, United States
The Eye Institute of Utah
🇺🇸Salt Lake City, Utah, United States
Silk Vision & Surgical Center
🇺🇸Annandale, Virginia, United States
Virginia Eye Consultants
🇺🇸Norfolk, Virginia, United States
Gundersen Clinic, Ltd.
🇺🇸La Crosse, Wisconsin, United States
Stanford University School of Medicine
🇺🇸Palo Alto, California, United States
Grutzmacher, Lewis and Sierra
🇺🇸Sacramento, California, United States
Eye Care Center of Virginia
🇺🇸Richmond, Virginia, United States
Center for Sight
🇺🇸Sacramento, California, United States
Batra Vision Medical Group
🇺🇸San Leandro, California, United States
Newman Lasik Centers
🇺🇸Sacramento, California, United States
Delta Eye Medical Group
🇺🇸Stockton, California, United States
Kaiser Permanente - Kaiser Network Patients in Northern California Only
🇺🇸Walnut Creek, California, United States
The Eye Institute of West Florida
🇺🇸Largo, Florida, United States
Eye Physicians and Surgeons, PC
🇺🇸Milford, Connecticut, United States
TLC of Miami The Laser Center of Coral Gables
🇺🇸Coral Gables, Florida, United States
Delray Eye Associates, PA
🇺🇸Delray Beach, Florida, United States
University of Iowa Hospitals and Clinics
🇺🇸Coralville, Iowa, United States
Kansas LasikPlus, P.A.
🇺🇸Leawood, Kansas, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
LCA-Vision Inc
🇺🇸Tampa, Florida, United States
Quantum Vision Centers
🇺🇸Belleville, Illinois, United States
LaskiPlus Vision Center
🇺🇸Louisville, Kentucky, United States
Eye Doctors of Washington
🇺🇸Chevy Chase, Maryland, United States
GBMC Dept. of Opthalmology/Mid-Atlantic Cornea Consultants
🇺🇸Baltimore, Maryland, United States
Verdier Eye Center P.L.C.
🇺🇸Grand Rapids, Michigan, United States
Wellish Vision Institute
🇺🇸Las Vegas, Nevada, United States
Pepose Vision Institute/ Lifelong Vision Foundation
🇺🇸Chesterfield, Missouri, United States
Ophthamology Consultants LLC
🇺🇸Saint Louis, Missouri, United States
CNY Eye Care
🇺🇸De Witt, New York, United States
Eye Associates of New Mexico
🇺🇸Albuquerque, New Mexico, United States
Carolina Vision Center
🇺🇸Fayetteville, North Carolina, United States
Comprehensive Eye Care of Central Ohio
🇺🇸Westerville, Ohio, United States
Casey Eye Institute/OHSU
🇺🇸Portland, Oregon, United States
Scheie Eye Institute, University of Pennsylvania School of Medicine
🇺🇸Philadelphia, Pennsylvania, United States
Corneal Associates, Wills Eye Institute
🇺🇸Philadelphia, Pennsylvania, United States
Bucci Laser Vision Institute
🇺🇸Wilkes-Barre, Pennsylvania, United States
Dell Laser Consultants
🇺🇸Austin, Texas, United States
Wright Vision Center
🇺🇸Rapid City, South Dakota, United States
Buena Vista Eyecare
🇺🇸El Paso, Texas, United States
Eye Consultants of Texas
🇺🇸Grapevine, Texas, United States
Slade and Baker Vision Center
🇺🇸Houston, Texas, United States
Focal Point Vision
🇺🇸San Antonio, Texas, United States
Beach Eye Care
🇺🇸Virginia Beach, Virginia, United States
Commonwealth Eye Associates
🇺🇸Richmond, Virginia, United States
Evergreen Eye Center
🇺🇸Federal Way, Washington, United States
The Eye Clinic Surgicenter
🇺🇸Billings, Montana, United States
Black Hills Regional Eye Institute
🇺🇸Rapid City, South Dakota, United States
Schein Ernst Eye Associates
🇺🇸Harrisburg, Pennsylvania, United States
Ophthalmic Partners of PA, P.C.
🇺🇸Bala-Cynwyd, Pennsylvania, United States