Safety & Efficacy of Corneal Collagen Cross-Linking in Eyes With Keratoconus or Corneal Ectasia After Refractive Surgery

NCT ID: NCT01459679

Last Updated: 2018-07-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1721 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2016-08-31

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.

Conditions

Keratoconus; Corneal Ectasia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

VibeX Treatment Group A

Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 8 minutes

Group Type: ACTIVE_COMPARATOR

KXL System (15 mW/cm2)

Intervention Type: DEVICE

UVA irradiation for 8 minutes at 15 mW/cm2

riboflavin ophthalmic solution

Intervention Type: DRUG

Drops of riboflavin ophthalmic solution will be applied in the eye every two minutes for 20 minutes

VibeX Treatment Group B

Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 4 minutes

Group Type: ACTIVE_COMPARATOR

KXL System (30 mW/cm2)

Intervention Type: DEVICE

UVA irradiation for 4 minutes at 30 mW/cm2

riboflavin ophthalmic solution

Intervention Type: DRUG

Drops of riboflavin ophthalmic solution will be applied in the eye every two minutes for 20 minutes

VibeX Treatment Group C

Corneal collagen cross-linking using riboflavin ophthalmic solution and ultraviolet-A (UVA) light for 2 minutes and 40 seconds

Group Type: ACTIVE_COMPARATOR

KXL System (45 mW/cm2)

Intervention Type: DEVICE

UVA irradiation for 2 minutes 40 seconds at 45 mW/cm2

riboflavin ophthalmic solution

Intervention Type: DRUG

Drops of riboflavin ophthalmic solution will be applied in the eye every two minutes for 20 minutes

Interventions

KXL System (15 mW/cm2)

UVA irradiation for 8 minutes at 15 mW/cm2

Intervention Type: DEVICE

KXL System (30 mW/cm2)

UVA irradiation for 4 minutes at 30 mW/cm2

Intervention Type: DEVICE

KXL System (45 mW/cm2)

UVA irradiation for 2 minutes 40 seconds at 45 mW/cm2

Intervention Type: DEVICE

riboflavin ophthalmic solution

Drops of riboflavin ophthalmic solution will be applied in the eye every two minutes for 20 minutes

Intervention Type: DRUG

Other Intervention Names

VibeX

Eligibility Criteria

Inclusion Criteria

1. Be at least 12 years of age, male or female, of any race;

2. 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;

3. Willingness and ability to follow all instructions and comply with schedule for follow-up visits;

4. 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);

5. BSCVA of ≥1 letter and ≤80 letters on ETDRS chart;

6. Presence of central or inferior steepening on the topographic map;

7. Contact Lens Wearers Only: Removal of contact lenses is required for a 1 week period prior to the screening visit(s);

8. 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;

9. Have a maximum corneal curvature as measured by Kmax of ≥ 47.00 D;

10. Having topographic evidence of keratoconus with a diagnosis of mild, moderate or severe keratoconus defined as the following:

• Mild Keratoconus

1. Axial topography consistent with keratoconus

2. Flat keratometry reading ≤ 51.00 D on topography map

• Moderate Keratoconus

1. Axial topography consistent with keratoconus

2. Flat keratometry reading ≥ 51.01 D and ≤ 56.00 D or astigmatism ≥ 8.00D on topography map

• Severe Keratoconus:

1. Axial topography consistent with keratoconus with marked areas of steepening

2. Flat keratometry reading ≥ 56.01 D on topography map

11. Having a diagnosis of corneal ectasia after refractive surgery;

12. Having axial topography consistent with ectasia;

Exclusion Criteria

1. Contraindications, sensitivity or known allergy to the test article(s) or their components;

2. 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;

3. Corneal pachymetry that is < 375 microns prior to epithelial debridement at the thinnest point in the eye to be treated;

4. Eyes which are aphakic;

5. Eyes which are pseudophakic and do not have a UV blocking lens implanted;

6. Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example:

1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, corneal dystrophy, etc.)

2. 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;

7. A history of delayed epithelial healing in the eye(s) to be treated;

8. Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests;

9. Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing;

10. Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.

11. A history of previous corneal crosslinking treatment in the eye to be treated;

12. 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;

13. 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;

14. A history of previous Limbal Relaxing Incision (LRI) procedure in the eye(s) to be treated;

15. In addition, the Investigator may exclude or discontinue any subject for any sound medical reason;

16. Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American-European Congress of Ophthalmic Surgery

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John Vukich, MD

Role: PRINCIPAL_INVESTIGATOR

American-European Congress of Ophthalmic Surgery

Locations

John Parker

Birmingham, Alabama, United States

Barnet Dulaney Perkins Eye Center

Phoenix, Arizona, United States

Advanced Vision Care

Los Angeles, California, United States

Stanford University School of Medicine

Palo Alto, California, United States

Grutzmacher, Lewis and Sierra

Sacramento, California, United States

Center for Sight

Sacramento, California, United States

Newman Lasik Centers

Sacramento, California, United States

Batra Vision Medical Group

San Leandro, 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

Mile High Corneal Specialists, PC

Denver, Colorado, United States

Manchester Ophthalmology

Manchester, Connecticut, 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

Braverman Eye Center

Hallandale, Florida, United States

The Eye Institute of West Florida

Largo, Florida, United States

Herschel Lasik

Orlando, Florida, United States

LCA-Vision Inc

Tampa, Florida, United States

Quantum Vision Centers

Belleville, Illinois, United States

University of Iowa Hospitals and Clinics

Coralville, Iowa, United States

Kansas LasikPlus, P.A.

Leawood, Kansas, United States

Grene Vision Group

Wichita, Kansas, United States

LaskiPlus Vision Center

Louisville, Kentucky, United States

Ochsner Medical Center

New Orleans, Louisiana, United States

Eyecare Medical Group

Portland, Maine, United States

GBMC Dept. of Opthalmology/Mid-Atlantic Cornea Consultants

Baltimore, Maryland, United States

Solomon Eye Physicians and Surgeons

Bowie, Maryland, United States

Eye Doctors of Washington

Chevy Chase, Maryland, United States

Boston Eye Group

Brookline, Massachusetts, United States

Ophthalmic Consultants of Boston

Waltham, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Henry Ford Health System

Detroit, Michigan, United States

Verdier Eye Center P.L.C.

Grand Rapids, Michigan, United States

Michigan Cornea Consultants

Southfield, Michigan, United States

Chu Vision Institute

Bloomington, Minnesota, United States

Eye Surgery and Laser Center

Madison, Mississippi, United States

Pepose Vision Institute/ Lifelong Vision Foundation

Chesterfield, Missouri, United States

Ophthamology Consultants LLC

St Louis, Missouri, United States

The Eye Clinic Surgicenter

Billings, Montana, United States

Eye Surgical Associates

Lincoln, Nebraska, United States

Kugler Vision, PC

Omaha, Nebraska, United States

Wellish Vision Institute

Las Vegas, Nevada, United States

Princeton Eye Group

Princeton, New Jersey, United States

Eye Associates of New Mexico

Albuquerque, New Mexico, United States

CNY Eye Care

De Witt, New York, United States

North Shore LIJ Health Systems

Great Neck, New York, United States

Ramapo Ophthalmology Associates, LLP

Pomona, New York, United States

Carolina Vision Center

Fayetteville, North Carolina, United States

Bagan Strinden Vision

Fargo, North Dakota, United States

Comprehensive Eye Care of Central Ohio

Westerville, Ohio, United States

Dean McGee Eye Institute

Oklahoma City, Oklahoma, United States

Devers Eye Institute

Portland, Oregon, United States

Casey Eye Institute/OHSU

Portland, Oregon, United States

Ophthalmic Partners of PA, P.C.

Bala-Cynwyd, Pennsylvania, United States

Schein Ernst Eye Associates

Harrisburg, Pennsylvania, United States

Scheie Eye Institute, University of Pennsylvania School of Medicine

Philadelphia, Pennsylvania, United States

Corneal Associates, Wills Eye Institute

Philadelphia, Pennsylvania, United States

Northeastern Eye Institute

Scranton, Pennsylvania, United States

Bucci Laser Vision Institute

Wilkes-Barre, Pennsylvania, United States

Black Hills Regional Eye Institute

Rapid City, South Dakota, United States

Wright Vision Center

Rapid City, South Dakota, United States

Vance Thompson Vision

Sioux Falls, South Dakota, United States

Loden Vision Center

Goodlettsville, Tennessee, United States

Wang Vision Institute

Nashville, Tennessee, United States

Dell Laser Consultants

Austin, Texas, United States

Buena Vista Eyecare

El Paso, Texas, United States

Eye Consultants of Texas

Grapevine, Texas, United States

Berkeley Eye Center

Houston, Texas, United States

Slade and Baker Vision Center

Houston, Texas, United States

Focal Point Vision

San Antonio, Texas, United States

Hoopes Vision

Draper, Utah, United States

The Eye Institute of Utah

Salt Lake City, Utah, United States

University of Utah Dept. of Ophthalmology & Visual Sciences

Salt Lake City, Utah, United States

Silk Vision & Surgical Center

Annandale, Virginia, United States

Virginia Eye Consultants

Norfolk, Virginia, United States

Commonwealth Eye Associates

Richmond, Virginia, United States

Eye Care Center of Virginia

Richmond, Virginia, United States

Beach Eye Care

Virginia Beach, Virginia, United States

Evergreen Eye Center

Federal Way, Washington, United States

Gundersen Clinic, Ltd.

La Crosse, Wisconsin, United States

Dean Foundation for Health, Research and Education, Inc.

Madison, Wisconsin, United States

Lilia Rivera

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

Other Identifiers

ACOS-KXL-001

Identifier Type: -

Identifier Source: org_study_id