Safety & Efficacy of Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01459679 |
Recruitment Status :
Terminated
First Posted : October 26, 2011
Last Update Posted : July 5, 2018
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Keratoconus Corneal Ectasia | Device: KXL System (15 mW/cm2) Device: KXL System (30 mW/cm2) Device: KXL System (45 mW/cm2) Drug: riboflavin ophthalmic solution | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1721 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Multi-Center, Randomized, Controlled Evaluation of the Safety & Efficacy of the KXL System With VibeX (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery |
Study Start Date : | July 2012 |
Actual Primary Completion Date : | January 2016 |
Actual Study Completion Date : | August 2016 |

Arm | Intervention/treatment |
---|---|
Active Comparator: VibeX Treatment Group A
Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 8 minutes
|
Device: KXL System (15 mW/cm2)
UVA irradiation for 8 minutes at 15 mW/cm2 Drug: riboflavin ophthalmic solution Drops of riboflavin ophthalmic solution will be applied in the eye every two minutes for 20 minutes
Other Name: VibeX |
Active Comparator: VibeX Treatment Group B
Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 4 minutes
|
Device: KXL System (30 mW/cm2)
UVA irradiation for 4 minutes at 30 mW/cm2 Drug: riboflavin ophthalmic solution Drops of riboflavin ophthalmic solution will be applied in the eye every two minutes for 20 minutes
Other Name: VibeX |
Active Comparator: VibeX Treatment Group C
Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 2 minutes and 40 seconds
|
Device: KXL System (45 mW/cm2)
UVA irradiation for 2 minutes 40 seconds at 45 mW/cm2 Drug: riboflavin ophthalmic solution Drops of riboflavin ophthalmic solution will be applied in the eye every two minutes for 20 minutes
Other Name: VibeX |
- Mean change in maximum corneal curvature (Kmax) from baseline [ Time Frame: Month 6 or 12 ]
- Comparison of treatment groups within each treatment indication [ Time Frame: Month 6 and 12 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria (all subjects):
- Be at least 12 years of age, male or female, of any race;
- Provide written informed consent and sign a HIPAA form. Patients who are under the age of 18 will need to sign an assent form as well as having a parent or legal guardian sign an informed consent;
- Willingness and ability to follow all instructions and comply with schedule for follow-up visits;
- For females capable of becoming pregnant, agree to have urine pregnancy testing performed prior to randomization of the study eye and on the day of the fellow eye treatment (which occurs between the 3 to 6 month study eye visits); must not be lactating, and must agree to use a medically acceptable form of birth control for at least one week prior to the randomization visit and continue to use the method until one month after the last dose of test article. Acceptable forms for birth control are spermicide with barrier, oral contraceptive, injectable or implantable method of contraception, transdermal contraceptive, intrauterine device, or surgical sterilization of partner. For non-sexually active females, abstinence will be considered an acceptable form of birth control. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (e.g. hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
- BSCVA of ≥1 letter and ≤80 letters on ETDRS chart;
- Presence of central or inferior steepening on the topographic map;
- Contact Lens Wearers Only: Removal of contact lenses is required for a 1 week period prior to the screening visit(s);
-
Contact Lens Wearers Only: manifest refraction must be stable between two visits which occur at least 7 days apart. A stable refraction is one in which the manifest refraction spherical equivalent and the average K (Km) on the topographer taken at the first visit do not differ by more than 0.75 D from the respective measurements taken at the second exam;
Inclusion Criteria (keratoconus subjects only):
- Have a maximum corneal curvature as measured by Kmax of ≥ 47.00 D;
-
Having topographic evidence of keratoconus with a diagnosis of mild, moderate or severe keratoconus defined as the following:
-
Mild Keratoconus
- Axial topography consistent with keratoconus
- Flat keratometry reading ≤ 51.00 D on topography map
-
Moderate Keratoconus
- Axial topography consistent with keratoconus
- Flat keratometry reading ≥ 51.01 D and ≤ 56.00 D or astigmatism ≥ 8.00D on topography map
-
Severe Keratoconus:
- Axial topography consistent with keratoconus with marked areas of steepening
- Flat keratometry reading ≥ 56.01 D on topography map
Inclusion Criteria (corneal ectasia subjects only):
-
- Having a diagnosis of corneal ectasia after refractive surgery;
- Having axial topography consistent with ectasia;
Exclusion Criteria (all subjects):
- Contraindications, sensitivity or known allergy to the test article(s) or their components;
- If female, be pregnant, nursing or planning a pregnancy or have a positive urine pregnancy test prior to the randomization or treatment of either eye or during the course of the study;
- Corneal pachymetry that is < 375 microns prior to epithelial debridement at the thinnest point in the eye to be treated;
- Eyes which are aphakic;
- Eyes which are pseudophakic and do not have a UV blocking lens implanted;
-
Previous ocular condition (other than refractive error) in the eye 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 erosion syndrome, corneal melt, corneal dystrophy, etc.)
- Clinically significant corneal scarring in the cross-linking treatment zone that is not related to keratoconus or corneal ectasia, in the investigator's opinion, will interfere with the cross-linking procedure;
- A history of delayed epithelial healing in the eye(s) to be treated;
- Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests;
- Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing;
- Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
- A history of previous corneal crosslinking treatment in the eye to be treated;
- Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device trial within 30 days of the study;
- A history of previous corneal surgery (other than LASIK or PRK for subjects with corneal ectasia) or the insertion of Intacs in the eye(s) to be treated;
- A history of previous Limbal Relaxing Incision (LRI) procedure in the eye(s) to be treated;
-
In addition, the Investigator may exclude or discontinue any subject for any sound medical reason;
Exclusion Criteria (Keratoconus subjects only):
- Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01459679

United States, Alabama | |
John Parker | |
Birmingham, Alabama, United States, 35233 | |
United States, Arizona | |
Barnet Dulaney Perkins Eye Center | |
Phoenix, Arizona, United States, 85016 | |
United States, California | |
Advanced Vision Care | |
Los Angeles, California, United States, 90067 | |
Stanford University School of Medicine | |
Palo Alto, California, United States, 94303 | |
Grutzmacher, Lewis and Sierra | |
Sacramento, California, United States, 95815 | |
Center for Sight | |
Sacramento, California, United States, 95816 | |
Newman Lasik Centers | |
Sacramento, California, United States, 95821 | |
Batra Vision Medical Group | |
San Leandro, California, United States, 94578 | |
Delta Eye Medical Group | |
Stockton, California, United States, 95207 | |
Kaiser Permanente - Kaiser Network Patients in Northern California Only | |
Walnut Creek, California, United States, 94598 | |
United States, Colorado | |
Mile High Corneal Specialists, PC | |
Denver, Colorado, United States, 80210 | |
United States, Connecticut | |
Manchester Ophthalmology | |
Manchester, Connecticut, United States, 06040 | |
Eye Physicians and Surgeons, PC | |
Milford, Connecticut, United States, 06460 | |
United States, Florida | |
TLC of Miami The Laser Center of Coral Gables | |
Coral Gables, Florida, United States, 33134 | |
Delray Eye Associates, PA | |
Delray Beach, Florida, United States, 33484 | |
Braverman Eye Center | |
Hallandale Beach, Florida, United States, 33009 | |
The Eye Institute of West Florida | |
Largo, Florida, United States, 33770 | |
Herschel Lasik | |
Orlando, Florida, United States, 32803 | |
LCA-Vision Inc | |
Tampa, Florida, United States, 33607 | |
United States, Illinois | |
Quantum Vision Centers | |
Belleville, Illinois, United States, 62226 | |
United States, Iowa | |
University of Iowa Hospitals and Clinics | |
Coralville, Iowa, United States, 52241 | |
United States, Kansas | |
Kansas LasikPlus, P.A. | |
Leawood, Kansas, United States, 66211 | |
Grene Vision Group | |
Wichita, Kansas, United States, 67208 | |
United States, Kentucky | |
LaskiPlus Vision Center | |
Louisville, Kentucky, United States, 40207 | |
United States, Louisiana | |
Ochsner Medical Center | |
New Orleans, Louisiana, United States, 70115 | |
United States, Maine | |
Eyecare Medical Group | |
Portland, Maine, United States, 04102 | |
United States, Maryland | |
GBMC Dept. of Opthalmology/Mid-Atlantic Cornea Consultants | |
Baltimore, Maryland, United States, 21204 | |
Solomon Eye Physicians and Surgeons | |
Bowie, Maryland, United States, 20716 | |
Eye Doctors of Washington | |
Chevy Chase, Maryland, United States, 20815 | |
United States, Massachusetts | |
Boston Eye Group | |
Brookline, Massachusetts, United States, 02446 | |
Ophthalmic Consultants of Boston | |
Waltham, Massachusetts, United States, 02451 | |
United States, Michigan | |
University of Michigan | |
Ann Arbor, Michigan, United States, 48105 | |
Henry Ford Health System | |
Detroit, Michigan, United States, 48202 | |
Verdier Eye Center P.L.C. | |
Grand Rapids, Michigan, United States, 49546 | |
Michigan Cornea Consultants | |
Southfield, Michigan, United States, 48034 | |
United States, Minnesota | |
Chu Vision Institute | |
Bloomington, Minnesota, United States, 55420 | |
United States, Mississippi | |
Eye Surgery and Laser Center | |
Madison, Mississippi, United States, 39110 | |
United States, Missouri | |
Pepose Vision Institute/ Lifelong Vision Foundation | |
Chesterfield, Missouri, United States, 63017 | |
Ophthamology Consultants LLC | |
Saint Louis, Missouri, United States, 63131 | |
United States, Montana | |
The Eye Clinic Surgicenter | |
Billings, Montana, United States, 59102 | |
United States, Nebraska | |
Eye Surgical Associates | |
Lincoln, Nebraska, United States, 68506 | |
Kugler Vision, PC | |
Omaha, Nebraska, United States, 68144 | |
United States, Nevada | |
Wellish Vision Institute | |
Las Vegas, Nevada, United States, 89119 | |
United States, New Jersey | |
Princeton Eye Group | |
Princeton, New Jersey, United States, 08540 | |
United States, New Mexico | |
Eye Associates of New Mexico | |
Albuquerque, New Mexico, United States, 87109 | |
United States, New York | |
CNY Eye Care | |
De Witt, New York, United States, 13214 | |
North Shore LIJ Health Systems | |
Great Neck, New York, United States, 11021 | |
Ramapo Ophthalmology Associates, LLP | |
Pomona, New York, United States, 10970 | |
United States, North Carolina | |
Carolina Vision Center | |
Fayetteville, North Carolina, United States, 28304 | |
United States, North Dakota | |
Bagan Strinden Vision | |
Fargo, North Dakota, United States, 58103 | |
United States, Ohio | |
Comprehensive Eye Care of Central Ohio | |
Westerville, Ohio, United States, 43082 | |
United States, Oklahoma | |
Dean McGee Eye Institute | |
Oklahoma City, Oklahoma, United States, 73104 | |
United States, Oregon | |
Devers Eye Institute | |
Portland, Oregon, United States, 97210 | |
Casey Eye Institute/OHSU | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
Ophthalmic Partners of PA, P.C. | |
Bala-Cynwyd, Pennsylvania, United States, 19004 | |
Schein Ernst Eye Associates | |
Harrisburg, Pennsylvania, United States, 17110 | |
Scheie Eye Institute, University of Pennsylvania School of Medicine | |
Philadelphia, Pennsylvania, United States, 19104 | |
Corneal Associates, Wills Eye Institute | |
Philadelphia, Pennsylvania, United States, 19107 | |
Northeastern Eye Institute | |
Scranton, Pennsylvania, United States, 18503 | |
Bucci Laser Vision Institute | |
Wilkes-Barre, Pennsylvania, United States, 18702 | |
United States, South Dakota | |
Black Hills Regional Eye Institute | |
Rapid City, South Dakota, United States, 57701 | |
Wright Vision Center | |
Rapid City, South Dakota, United States, 57701 | |
Vance Thompson Vision | |
Sioux Falls, South Dakota, United States, 57108 | |
United States, Tennessee | |
Loden Vision Center | |
Goodlettsville, Tennessee, United States, 37072 | |
Wang Vision Institute | |
Nashville, Tennessee, United States, 37203 | |
United States, Texas | |
Dell Laser Consultants | |
Austin, Texas, United States, 78746 | |
Buena Vista Eyecare | |
El Paso, Texas, United States, 79902 | |
Eye Consultants of Texas | |
Grapevine, Texas, United States, 76051 | |
Berkeley Eye Center | |
Houston, Texas, United States, 77027 | |
Slade and Baker Vision Center | |
Houston, Texas, United States, 77027 | |
Focal Point Vision | |
San Antonio, Texas, United States, 78229 | |
United States, Utah | |
Hoopes Vision | |
Draper, Utah, United States, 84020 | |
The Eye Institute of Utah | |
Salt Lake City, Utah, United States, 84107 | |
University of Utah Dept. of Ophthalmology & Visual Sciences | |
Salt Lake City, Utah, United States, 84132 | |
United States, Virginia | |
Silk Vision & Surgical Center | |
Annandale, Virginia, United States, 22003 | |
Virginia Eye Consultants | |
Norfolk, Virginia, United States, 23502 | |
Commonwealth Eye Associates | |
Richmond, Virginia, United States, 23238 | |
Eye Care Center of Virginia | |
Richmond, Virginia, United States, 23294 | |
Beach Eye Care | |
Virginia Beach, Virginia, United States, 23454 | |
United States, Washington | |
Evergreen Eye Center | |
Federal Way, Washington, United States, 98003 | |
United States, Wisconsin | |
Gundersen Clinic, Ltd. | |
La Crosse, Wisconsin, United States, 54601 | |
Dean Foundation for Health, Research and Education, Inc. | |
Madison, Wisconsin, United States, 43715 | |
Puerto Rico | |
Lilia Rivera | |
San Juan, Puerto Rico, 00918 |
Principal Investigator: | John Vukich, MD | American-European Congress of Ophthalmic Surgery |
Responsible Party: | American-European Congress of Ophthalmic Surgery |
ClinicalTrials.gov Identifier: | NCT01459679 |
Other Study ID Numbers: |
ACOS-KXL-001 |
First Posted: | October 26, 2011 Key Record Dates |
Last Update Posted: | July 5, 2018 |
Last Verified: | June 2018 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Keratoconus Corneal Diseases Dilatation, Pathologic Eye Diseases Pathological Conditions, Anatomical Riboflavin Ophthalmic Solutions Pharmaceutical Solutions |
Vitamin B Complex Vitamins Micronutrients Nutrients Growth Substances Physiological Effects of Drugs Photosensitizing Agents Dermatologic Agents |