A Multi-Center, Randomized, Controlled Evaluation of the Safety and 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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by American-European Congress of Ophthalmic Surgery
Sponsor:
Information provided by (Responsible Party):
American-European Congress of Ophthalmic Surgery
ClinicalTrials.gov Identifier:
NCT01459679
First received: September 19, 2011
Last updated: October 8, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Controlled Evaluation of the Safety and 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

Resource links provided by NLM:


Further study details as provided by American-European Congress of Ophthalmic Surgery:

Primary Outcome Measures:
  • Mean change in maximum corneal curvature (Kmax) from baseline [ Time Frame: Month 6 or 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Comparison of treatment groups within each treatment indication [ Time Frame: Month 6 and 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 4000
Study Start Date: July 2012
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria (all subjects):

  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;

    Inclusion Criteria (keratoconus subjects only):

  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

    Inclusion Criteria (corneal ectasia subjects only):

  11. Having a diagnosis of corneal ectasia after refractive surgery;
  12. Having axial topography consistent with ectasia;

Exclusion Criteria (all subjects):

  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;

    Exclusion Criteria (Keratoconus subjects only):

  16. Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01459679

Contacts
Contact: Jennifer Mah 781-768-3475 jmah@avedro.com

  Hide Study Locations
Locations
United States, Alabama
John Parker Recruiting
Birmingham, Alabama, United States, 35233
Contact: Preston Fuchs    205-933-1077    Preston.parkercornea@gmail.com   
Principal Investigator: John Parker, MD         
United States, Arizona
Barnet Dulaney Perkins Eye Center Recruiting
Phoenix, Arizona, United States, 85016
Contact: Patti Crincoli    602-508-4871    pcrincoli@bdpec.com   
Contact: Cheryl Gresham       cgresham@bdpec.com   
Principal Investigator: Robert Fintelmann, MD         
United States, California
Advanced Vision Care Recruiting
Los Angeles, California, United States, 90067
Contact: Ann McLean    310-229-1220    avcweb@aol.com   
Contact: Nicole Fram, MD    310-229-1220    nicfram@yahoo.com   
Principal Investigator: Nicole Fram, MD         
Stanford University School of Medicine Recruiting
Palo Alto, California, United States, 94303
Contact: Theresa Enriquez    650-498-4573    tenriquez@stanfordmed.org   
Principal Investigator: Edward Manche, MD         
Newman Lasik Centers Recruiting
Sacramento, California, United States, 95821
Contact: Margaret Peterson    916-256-1900    mpet3@surewest.net   
Principal Investigator: Leonard Newman, MD         
Grutzmacher, Lewis and Sierra Recruiting
Sacramento, California, United States, 95815
Contact: Monica Robinson, OD    916-649-1515    mrobinson@saceye.com   
Principal Investigator: Patricia Sierra, MD         
Center for Sight Recruiting
Sacramento, California, United States, 95816
Contact: Jasmin Ly, OD    916-446-2020 ext 132    jly@liangvision.com   
Principal Investigator: Keith Liang, MD         
Batra Vision Medical Group Recruiting
San Leandro, California, United States, 94578
Contact: Claudia Silva    510-276-1515    csilva@batravision.com   
Principal Investigator: Nicholas Batra, MD         
Kaiser Permanente - Kaiser Network Patients in Northern California Only Recruiting
Santa Rosa, California, United States, 95403
Contact: Laura Ligon    707-566-5905    laura.ligon@kp.org   
Principal Investigator: Patrick Paglen, MD         
Delta Eye Medical Group Recruiting
Stockton, California, United States, 95207
Contact: Bev Jacobs    209-478-1797    deltaeyebev@yahoo.com   
Principal Investigator: Jeffrey Ing, MD         
United States, Colorado
Mile High Corneal Specialists, PC Recruiting
Denver, Colorado, United States, 80210
Contact: Laura McKenney    303-495-3366    lmckenney@milehighcornea.com   
Principal Investigator: William Richheimer, MD         
United States, Connecticut
Manchester Ophthalmology Recruiting
Manchester, Connecticut, United States, 06040
Contact: Luljeta VanBuren    860-649-5177    manchesterophthalmology@yahoo.com   
Contact: Kim Lefevre       klefevre71@aol.com   
Principal Investigator: Daniel Petashnick, MD         
Eye Physicians and Surgeons, PC Recruiting
Milford, Connecticut, United States, 06460
Contact: Jan Stanton    203-876-9203    jmsoptlasik@yahoo.com   
Principal Investigator: Seth Meskin, MD         
United States, Florida
TLC of Miami The Laser Center of Coral Gables Recruiting
Coral Gables, Florida, United States, 33134
Contact: Joanne Leopold    305-461-0003    joanne.leopold@tlcvision.com   
Principal Investigator: Alberto Aran, MD         
Delray Eye Associates, PA Recruiting
Delray Beach, Florida, United States, 33484
Contact: Ellen Salvati    561-498-8100    ellens@delrayeye.com   
Principal Investigator: Steven Rosenfeld, MD         
Braverman Eye Center Recruiting
Hallandale Beach, Florida, United States, 33009
Contact: Rosemary Hartford    954-456-4820    rosemary@bravermaneyecenter.com   
Principal Investigator: Stanley Braverman, MD         
The Eye Institute of West Florida Recruiting
Largo, Florida, United States, 33770
Contact: Renee Bondurant    727-450-4668    renee.bondurant@eyespecialist.com   
Contact: Rachel Harden    727-450-4668    rharden11@gmail.com   
Principal Investigator: Neel Desai, MD         
Herschel Lasik Recruiting
Orlando, Florida, United States, 32803
Contact: Michelle McLellan    407-894-8081    michelle@herschellasik2020.com   
Principal Investigator: Mark Herschel, MD         
LCA-Vision Inc Recruiting
Tampa, Florida, United States, 33607
Contact: Patti Morales    813-870-3937    pmorales@lca.com   
Principal Investigator: Lewis Groden, MD         
United States, Illinois
Illinois Eye Surgeons Recruiting
Belleville, Illinois, United States, 62226
Contact: Christa Garner    618-406-4604    cgarner@illinoiseye.com   
Principal Investigator: Michael Jones, MD         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Coralville, Iowa, United States, 52241
Contact: Lisa Milder    319-356-2861    lisa-milder@uiowa.edu   
Principal Investigator: Mark Greiner, MD         
United States, Kansas
Kansas LasikPlus, P.A. Recruiting
Leawood, Kansas, United States, 66211
Contact: Joel Formanek    913-647-1010    jformanek@lca.com   
Principal Investigator: Dean Ellis, MD         
Grene Vision Group Recruiting
Wichita, Kansas, United States, 67208
Contact: Michelle Anderson    316-691-3977    manderson@grenevisiongroup.com   
Principal Investigator: Dasa Gangadhar, MD         
United States, Kentucky
LaskiPlus Vision Center Recruiting
Louisville, Kentucky, United States, 40207
Contact: Tim Morgan    502-899-3288    tmorgan@lca.com   
Principal Investigator: Jason Greenberg, MD         
United States, Louisiana
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Donnalee Trapani    504-894-2864    dtrapani@ochsner.org   
Principal Investigator: Pulin Shah, MD         
United States, Maine
Eyecare Medical Group Completed
Portland, Maine, United States, 04102
United States, Maryland
GBMC Dept. of Opthalmology/Mid-Atlantic Cornea Consultants Recruiting
Baltimore, Maryland, United States, 21204
Contact: Jessica Byer    410-616-9952    jbyer731@gmail.com   
Principal Investigator: Sudeep Pramanik, MD         
Solomon Eye Physicians and Surgeons Recruiting
Baltimore, Maryland, United States, 20716
Contact: Cassie Brisbane    301-237-8563    cassiebrisbane@solomoneye.net   
Principal Investigator: Jonathan D Solomon, MD         
Eye Doctors of Washington Recruiting
Chevy Chase, Maryland, United States, 20815
Contact: Melissa Barbor, MD    301-215-7100 ext 1201    mbarbor.od@verizon.net   
Principal Investigator: Thomas E Clinch, MD         
United States, Massachusetts
Boston Eye Group Recruiting
Brookline, Massachusetts, United States, 02446
Contact: Steve Robinson    617-566-0062 ext 394    steve@bostonlaser.com   
Principal Investigator: Samir Melki, MD         
Ophthalmic Consultants of Boston Recruiting
Waltham, Massachusetts, United States, 02451
Contact: Samantha Hulbert    617-314-2703    shulbert@eyeboston.com   
Principal Investigator: Michael Raizman, MD         
United States, Michigan
University of Michigan Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Munira Hussain    734-647-8397    hussain@umich.edu   
Principal Investigator: Shahzad Mian, MD         
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Contact: Julianne Hall    313-916-2481    Jhall5@hfhs.org   
Principal Investigator: Colleen Grace, MD         
Verdier Eye Center P.L.C. Recruiting
Grand Rapids, Michigan, United States, 49546
Contact: Paula Johnson    616-949-2001    pjohnson@verdiereyecenter.com   
Principal Investigator: David Verdier, MD         
Michigan Cornea Consultants Recruiting
Southfield, Michigan, United States, 48034
Contact: Liz Brazier    248-350-2139    liz.brazier@yahoo.com   
Principal Investigator: Steven Dunn         
United States, Minnesota
Chu Vision Institute Recruiting
Bloomington, Minnesota, United States, 55420
Contact: Nic Jacobs    952-835-1235 ext 205    nic.jacobs@chuvision.com   
Principal Investigator: Ralph Y Chu, MD         
United States, Mississippi
Eye Surgery and Laser Center Recruiting
Jackson, Mississippi, United States, 39202
Contact: Allison Reno    601-985-9120    areno@eyegroupms.com   
Principal Investigator: William Ashford, MD         
United States, Missouri
Pepose Vision Institute/ Lifelong Vision Foundation Recruiting
Chesterfield, Missouri, United States, 63017
Contact: Farrah Shaikh    636-534-5126    fshaikh@lifelongvisionfoundation.org   
Principal Investigator: Jay Pepose, MD, PhD         
Ophthamology Consultants LLC Recruiting
St. Louis, Missouri, United States, 63131
Contact: Stephanie Williams    314-686-4401    swilliams@ocstl.com   
Principal Investigator: Joseph P Gira, MD         
United States, Montana
The Eye Clinic Surgicenter Recruiting
Billings, Montana, United States, 59102
Contact: Cheri Salthe    406-252-6608    cheri@theeyeclinicsurgicenter.com   
Principal Investigator: Byron Smith, MD         
United States, Nebraska
Eye Surgical Associates Recruiting
Lincoln, Nebraska, United States, 68506
Contact: Jody Hemberger    402-484-9000    JHemberger@esa-neb.com   
Principal Investigator: Gregory Sutton, MD         
Kugler Vision, PC Recruiting
Omaha, Nebraska, United States, 68144
Contact: Linda Morgan    402-558-2211    drmorgan@lasikomaha.com   
Principal Investigator: Lance Kugler, MD         
United States, Nevada
Wellish Vision Institute Recruiting
Las Vegas, Nevada, United States, 89119
Contact: Michael Peterson    702-932-4266    mpeterson@wellish.com   
Principal Investigator: Kent Wellish, MD         
United States, New Jersey
Princeton Eye Group Recruiting
Princeton, New Jersey, United States, 08540
Contact: Janet Bergan    609-924-9200    willslaser@yahoo.com   
Principal Investigator: Anita Miedziak, MD         
United States, New Mexico
Eye Associates of New Mexico Recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Sharon Calhoun    505-830-5245    slcalhoun@eyenm.com   
Principal Investigator: Kenneth Himmel, MD         
United States, New York
CNY Eye Care Recruiting
De Witt, New York, United States, 13214
Contact: Lori Mackessy    315-445-1577    lori@cnyeyecare.com   
Principal Investigator: Robert Weisenthal, MD         
North Shore LIJ Health Systems Recruiting
Great Neck, New York, United States, 11021
Contact: Victoria Leo       vleo@nshs.edu   
Principal Investigator: Carolyn Shih, MD         
Ramapo Ophthalmology Associates, LLP Recruiting
Pomona, New York, United States, 10970
Contact: Evelyn Bay    845-362-1450    ebay@ramapoeyecare.com   
Principal Investigator: Richard Gordon, MD         
United States, North Carolina
Carolina Vision Center Recruiting
Fayetteville, North Carolina, United States, 28304
Contact: Rebecca Surles    910-221-3672    rebecca@carolinavisioncenter.com   
Principal Investigator: Michael Woodcock, MD         
United States, North Dakota
Bagan Strinden Vision Recruiting
Fargo, North Dakota, United States, 58103
Contact: Melanie Rinkenberger    701-293-8242    baganstrindenvision@hotmail.com   
Principal Investigator: Steven Bagan, MD         
United States, Ohio
Comprehensive Eye Care of Central Ohio Recruiting
Westerville, Ohio, United States, 43082
Contact: Ashley George    614-890-5692 ext 136    ashley@compeyecare.com   
Principal Investigator: Kenneth Beckman, MD         
United States, Oklahoma
Dean McGee Eye Institute Recruiting
Oklahoma City, Oklahoma, United States, 73104
Contact: Vanessa Bergman    405-271-6307    Vanessa-Bergman@dmei.org   
Principal Investigator: Donald Stone, MD         
United States, Oregon
Casey Eye Institute/OHSU Recruiting
Portland, Oregon, United States, 97239
Contact: Brenda Purvis    503-494-3620    purvisb@ohsu.edu   
Principal Investigator: Winston Chamberlain, MD         
Devers Eye Institute Recruiting
Portland, Oregon, United States, 97210
Contact: Kelsey Oakes    503-413-8377    koakes@deverseye.org   
Contact: Zach Mayko       zmayko@deverseye.org   
Principal Investigator: Michael Straiko, MD         
United States, Pennsylvania
Ophthalmic Partners of PA, P.C. Recruiting
Bala Cynwyd, Pennsylvania, United States, 19004
Contact: Irene Spanelis    484-434-2706    ispanelis@oppdoctors.com   
Principal Investigator: Brandon Ayres, MD         
Schein Ernst Eye Associates Recruiting
Harrisburg, Pennsylvania, United States, 17110
Contact: Nicole Albright    717-233-3937    seea.nicolea@gmail.com   
Principal Investigator: Gautam Mishra, MD         
Scheie Eye Institute, University of Pennsylvania School of Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Joan DuPont    215-662-8038    Joan.DuPont@uphs.upenn.edu   
Principal Investigator: Stephen Orlin, MD         
Corneal Associates, Wills Eye Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Dave King    215-928-3174    dking@willseye.org   
Contact: Mike Lindsay       mlindsay@willseye.org   
Principal Investigator: Christopher Rapuano, MD         
Northeastern Eye Institute Recruiting
Scranton, Pennsylvania, United States, 18503
Contact: Donna Kunz    570-342-3145    dkunz@echoes.net   
Principal Investigator: Thomas Boland, MD         
Bucci Laser Vision Institute Recruiting
Wilkes-Barre, Pennsylvania, United States, 18702
Contact: Ruth Evans    570-825-5949    Ruth@buccivision.com   
Principal Investigator: Frank A Bucci, MD         
United States, South Dakota
Wright Vision Center Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Angela Walker    605-718-9413    awalker@wrightvisioncenter.com   
Contact: Carol Bordewyck       cbordewyck@wrightvisioncenter.com   
Principal Investigator: Paul Wright, MD         
Black Hills Regional Eye Institute Recruiting
Rapid City, South Dakota, United States, 57701
Contact: Alexis Barber    605-719-3153    abarber@BHREI.com   
Principal Investigator: Stephen Khachikian, MD         
Vance Thompson Vision Recruiting
Sioux Falls, South Dakota, United States, 57108
Contact: Bob Patterson    605-371-7074    bob.patterson@vancethompsonvision.com   
Principal Investigator: Vance Thompson, MD         
United States, Tennessee
Loden Vision Center Recruiting
Goodlettsville, Tennessee, United States, 37072
Contact: Katie Lamberth    615-859-3937    studies@lodenvision.com   
Principal Investigator: James Loden, MD         
Wang Vision Institute Recruiting
Nashville, Tennessee, United States, 37203
Contact: Nathan Rock    615-321-8881    nathan@wangvisioninstitute.com   
Principal Investigator: Ming Wang, MD         
United States, Texas
Dell Laser Consultants Recruiting
Austin, Texas, United States, 78746
Contact: Melissa Ciccarelli    512-347-0255    melissaciccarelli@yahoo.com   
Principal Investigator: Steven Dell, MD         
Buena Vista Eyecare Recruiting
El Paso, Texas, United States, 79902
Contact: Guadalupe Lucero       bvecep@gmail.com   
Principal Investigator: Ruben Ramirez, MD         
Eye Consultants of Texas Recruiting
Grapevine, Texas, United States, 76051
Contact: Stacey Allen    817-410-2030    sallen@eyecontx.com   
Contact: Fariba Parmer    817-703-3140    fparmer@eyecontx.com   
Principal Investigator: Phillips Labor, MD         
Slade and Baker Vision Center Recruiting
Houston, Texas, United States, 77027
Contact: Leticia Fernandez    713-626-5544    leticia@visiontexas.com   
Principal Investigator: Stephen Slade, MD         
Berkeley Eye Center Recruiting
Houston, Texas, United States, 77027
Contact: Bobby Perez    713-620-7644    bobby.perez@berkeleyeye.com   
Principal Investigator: Erin Doe, MD         
Focal Point Vision Recruiting
San Antonio, Texas, United States, 78229
Contact: Lisa Navarro    210-614-3600 ext 113    navarro@focalpointvision.com   
Principal Investigator: James D Lehmann, MD         
United States, Utah
Hoopes Vision Recruiting
Draper, Utah, United States, 84020
Contact: Steven Linn    801-568-0200    steve@hoopesvision.com   
Principal Investigator: Robert Rivera, MD         
University of Utah Dept. of Ophthalmology & Visual Sciences Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Katie Farnsworth    801-585-6647    katie.farnsworth@utah.edu   
Principal Investigator: Majid Moshirfar, MD         
The Eye Institute of Utah Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Natalie Forcht    801-263-5735    nforcht@theeyeinstitute.com   
Principal Investigator: Darcy Wolsey, MD         
United States, Virginia
Silk Vision & Surgical Center Recruiting
Annandale, Virginia, United States, 22003
Contact: Jessica Alvarado, M.D.    703-876-9700    assistant@silkvision.net   
Principal Investigator: Wesam Silk, MD         
Virginia Eye Consultants Recruiting
Norfolk, Virginia, United States, 23502
Contact: Darrel Westbrook    757-961-2964    dwestbrook@vec2020.com   
Contact: Brianne Anthony    757-961-2948    banthony@vec2020.com   
Principal Investigator: John Sheppard, MD         
Commonwealth Eye Associates Recruiting
Richmond, Virginia, United States, 23238
Contact: Tina Sweger    804-740-7474    tina@commonwealtheye.com   
Principal Investigator: Joseph Iuorno, MD         
Eye Care Center of Virginia Recruiting
Richmond, Virginia, United States, 23226
Contact: Danielle Burruss    804-330-9303 ext 107    msblueyez19@aim.com   
Principal Investigator: Garth Stevens, MD         
Beach Eye Care Recruiting
Virginia Beach, Virginia, United States, 23454
Contact: Jennifer Brountas    757-961-3665    jbrountas@beacheyecare.com   
Principal Investigator: Vivek Jain, MD         
United States, Washington
Evergreen Eye Center Recruiting
Federal Way, Washington, United States, 98003
Contact: Scott Honda    206-212-2156    scott@EvergreenEye.com   
Principal Investigator: Gary Chung, MD         
United States, Wisconsin
Gundersen Clinic, Ltd. Recruiting
La Crosse, Wisconsin, United States, 54601
Contact: Shelly Clements    608-775-6782    rmclemen@gundluth.org   
Principal Investigator: Paul Kuck, MD         
Dean Foundation for Health, Research and Education, Inc. Recruiting
Middleton, Wisconsin, United States, 53562
Contact: Lynn Dombrowicki    608-282-2074    Lynn.Dombrowicki@deancare.com   
Principal Investigator: John Vukich, MD         
Puerto Rico
Lilia Rivera Recruiting
San Juan, Puerto Rico, 00918
Contact: Lilia Rivera    787-250-7746    dralir9@gmail.com   
Principal Investigator: Lilia Rivera, MD         
Sponsors and Collaborators
American-European Congress of Ophthalmic Surgery
Investigators
Principal Investigator: John Vukich, MD American-European Congress of Ophthalmic Surgery
  More Information

No publications provided

Responsible Party: American-European Congress of Ophthalmic Surgery
ClinicalTrials.gov Identifier: NCT01459679     History of Changes
Other Study ID Numbers: ACOS-KXL-001
Study First Received: September 19, 2011
Last Updated: October 8, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Corneal Diseases
Dilatation, Pathologic
Keratoconus
Eye Diseases
Pathological Conditions, Anatomical
Ophthalmic Solutions
Pharmaceutical Solutions
Riboflavin
Dermatologic Agents
Growth Substances
Micronutrients
Pharmacologic Actions
Photosensitizing Agents
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Vitamin B Complex
Vitamins

ClinicalTrials.gov processed this record on October 23, 2014