Cornea Preservation Time Study (CPTS)

This study is currently recruiting participants.
Verified May 2013 by Case Western Reserve University
Sponsor:
Collaborators:
Jaeb Center for Health Research
Information provided by (Responsible Party):
Jonathan Lass, MD, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT01537393
First received: February 15, 2012
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to determine if the 3-year graft failure rate following endothelial keratoplasty performed with donor corneas with a preservation time of 8 to 14 days is non-inferior to the failure rate when donor corneas with a preservation time of 7 or fewer days are used.


Condition Intervention Phase
Cornea Tissue Preservation Time
Biological: Cornea tissue transplant
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Corneal Preservation Time on Long-Term Graft Success

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Corneal Graft Failure [ Time Frame: Participants will be assessed for this outcome for 3 years following surgery ] [ Designated as safety issue: Yes ]

    Graft failure, defined as the occurrence of one of the following within 3 years of surgery:

    • Regrafting of the study eye for any reason
    • Cornea which remains cloudy without clearing, according to the following:

      1. cloudy cornea on the first postoperative day which does not clear within 8 weeks OR
      2. cloudy cornea which was initially clear postoperatively but becomes and remains cloudy for 3 months without clearing.


Secondary Outcome Measures:
  • Endothelial cell density [ Time Frame: 3 years from surgery ] [ Designated as safety issue: No ]
    Endothelial cell density at 3 years from surgery, conditional on graft survival at 3 years from surgery.


Estimated Enrollment: 1330
Study Start Date: March 2012
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Preservation Time Group 1
Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.
Biological: Cornea tissue transplant
Cornea tissue preserved either 7 or less days or 8 to 14 days.
Preservation Time Group 2
Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.
Biological: Cornea tissue transplant
Cornea tissue preserved either 7 or less days or 8 to 14 days.

Detailed Description:

When the donor cornea is removed from the person who died, it is prepared for transplantation by an eye bank. The donor cornea is placed into a liquid that helps preserve the cornea until it is transplanted. The Food and Drug Administration (FDA) has approved storage of the cornea in this liquid for up to 14 days before the transplant. The purpose of this study is to see if the length of time the donor cornea is kept in the preservation liquid before the transplant affects the likelihood of the transplant being successful. We will follow participants for 3 years after transplant to see if there are any differences in transplant success or in the number of transplanted endothelial cells (the layer of cells that line the undersurface of the cornea) on the corneas that were preserved for 7 days or less compared to those preserved between 8 and 14 days. We have no reason to believe that there is any greater risk for transplant failure with either preservation time group.

  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Study Participant Eligibility Criteria

  • Study Participant Inclusion Criteria

    1. Age range 30-<91 years with minimum life expectancy of at least 3 years.
    2. Willingness to return for follow-up study visits at 1 day, 1 week, 1 month, 6 months, 1 year, 2 years and 3 years.
    3. Fluent in English or Spanish.
  • Study Participant Exclusion Criteria 1) Decisionally and/or cognitively impaired

Study Eye Eligibility Criteria

  • Study Eye Inclusion Criteria

    1. EK is scheduled between 10 and 60 days after enrollment

      • The 10-day requirement relates to the need to be able to randomly assign the eye to either intervention group.
      • The 60-day requirement relates to the need to have current eligibility and enrollment data at the time of surgery. If surgery is postponed to >60 days after the initial enrollment visit, a new Baseline Visit and eligibility assessment will have to be performed.
    2. Presence of a condition related to endothelial dysfunction which will be treated by EK.
  • Eligible indications for EK include:

    • Presence of FECD meeting at least one of the following:

      • Phakic FECD
      • Phakic FECD with cataract

        • Triple procedure including EK for FECD, cataract extraction and posterior chamber intraocular lens implantation (IOL) is allowed
      • Aphakic FECD
      • Pseudophakic FECD with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber IOL
    • Aphakic or pseudophakic corneal edema with posterior capsule supported, suture-fixated, or sulcus-supported posterior chamber IOL without FECD
  • Study Eye Exclusion Criteria

    1. Prior EK
    2. Indication for surgery that is not suitable for EK (e.g, keratoconus, stromal dystrophies and scars)
    3. Presence of a condition that has a very high probability for failure (e.g., failed EK or PKP, heavily vascularized cornea, uncontrolled uveitis)
    4. Other primary endothelial dysfunction conditions including posterior polymorphous corneal dystrophy and congenital hereditary corneal dystrophy
    5. Anterior chamber IOL in study eye prior to or anticipated during EK
    6. Planned intraocular lens exchange of an anterior chamber IOL with a posterior chamber IOL in study eye at time of study EK
    7. Pre-operative central sub-epithelial or stromal scarring that the investigator believes is visually significant and could impact post-operative stromal clarity assessment
    8. Stromal vascularization that is visually significant (by investigator's judgment)
    9. Presence of anterior synechiae (iris to cornea)
    10. Peripheral anterior synechiae (iris to angle) in the angle greater than a total of three clock hours
    11. Hypotony (Intraocular pressure <10 mm Hg)
    12. Uncontrolled (defined as intraocular pressure > 25mm Hg) glaucoma with or without prior filtering surgery or shunt or mini-shunt placement.

      • A shunt or mini-shunt is any device implanted to lower intraocular pressure through an external route (e.g Ahmed) or internal route (e.g. Glaukos) that is present in the anterior chamber angle or extends into the anterior chamber.
    13. Controlled glaucoma with prior shunt or mini-shunt placement for glaucoma

      • Note: FECD or pseudophakic/aphakic corneal edema with posterior chamber IOL that also have undergone filtering surgery (without shunt or mini-shunt) in which glaucoma is currently considered under control will be eligible
    14. Fellow eye visual acuity < 20/200 that is not correctable with EK

Eligibility Criteria for Second Study Eye

  1. Study participant has already enrolled one eye
  2. The second eye meets all study eye inclusion and exclusion criteria (2.2.2 and 2.2.3)
  3. EK surgery in second eye is not planned within 6 weeks of EK on first study eye
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01537393

Contacts
Contact: Loretta Szczotka-Flynn, OD, PhD 216-844-7934 loretta.szczotka@uhhospitals.org

  Hide Study Locations
Locations
United States, California
Doheny Eye Institute Recruiting
Beverly Hills, California, United States, 90211
Contact: John Gil-Flamer    323-442-6782    gilflame@usc.edu   
Principal Investigator: Neda Shamie, MD         
Jules Stein Eye Institute Recruiting
Los Angeles, California, United States, 90095
Contact: Marianne Esguerra    310-794-5604    Esguerra@jsei.ucla.edu   
Principal Investigator: Anthony Aldave, MD         
Eye Care of San Diego Recruiting
San Diego, California, United States, 92103
Contact: Jennifer Manke    619-296-8525 ext 133    Jennifer@eyecareofsandiego.com   
Principal Investigator: John Bokosky, MD         
University of California, San Francisco Recruiting
San Francisco, California, United States, 94110
Contact: Alexandra Neiman    415-206-3123    neimana@vision.ucsf.edu   
Principal Investigator: Bennie Jeng, MD         
United States, Florida
Bascom Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Contact: Janika San Roman    305-326-6352    JSanRoman@med.miami.edu   
Principal Investigator: Sonia Yoo, MD         
Center for Sight Recruiting
Sarasota, Florida, United States, 34239
Contact: Ginger Moritz    941-925-2020 ext 26211    gmoritz@centerforsight.net   
Principal Investigator: William Lahners, MD         
United States, Georgia
Eye Consultants of Atlanta Recruiting
Atlanta, Georgia, United States, 30339
Contact: Teresa Long    404-351-2220 ext 1168    teresa_long@eyeconsultants.net   
Principal Investigator: Barry Lee, MD         
Woolfson Eye Institute Recruiting
Atlanta, Georgia, United States, 30328
Contact: Jodi Miller    770-804-1684 ext 148    jmiller@woolfsoneye.com   
Principal Investigator: Doyle Stulting, MD         
United States, Illinois
University of Illinois Eye and Eye Recruiting
Chicago, Illinois, United States, 60612
Contact: Dolores Byrne    312-996-8937    dolobyrn@uic.edu   
Principal Investigator: Elmer Tu, MD         
NorthShore University Health System Recruiting
Glenview, Illinois, United States, 60026
Contact: Mira Shiloach    847-657-1750    MShiloach@northshore.org   
Principal Investigator: Marian Macsai, MD         
United States, Iowa
University of Iowa Hospitals and Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Constance Mullinix    319-356-2861    constance-mullinnix@uiowa.edu   
Principal Investigator: Kenneth Goins, MD         
United States, Kentucky
University of Kentucky Ophthalmology Recruiting
Lexington, Kentucky, United States, 40503
Contact: Jane Webb    859-275-4001    jwebb40034@adelphia.net   
Principal Investigator: Woodford VanMeter, MD         
United States, Maryland
Mid-Atlantic Cornea Consultants Recruiting
Baltimore, Maryland, United States, 21204
Contact: Hillary Leibich    410-616-9952    hyphema31@gmail.com   
Principal Investigator: Sudeep Pramanik, MD         
Johns Hopkins/Wilmer Eye Institute Recruiting
Baltimore, Maryland, United States, 21205
Contact: Nadia Wong    410-955-5080    nwong7@jhmi.edu   
Principal Investigator: Walter Stark, MD         
Eye Consultants of Maryland Recruiting
Owings Mills, Maryland, United States, 21117
Contact: William Bolt    410-581-2020    greyfoxod@verizon.net   
Principal Investigator: Verinder Nirankari, MD         
United States, Massachusetts
Ophthalmic Consultants of Boston Recruiting
Boston, Massachusetts, United States, 02114
Contact: Allison Coombs    617-314-2703    acoombs@eyeboston.com   
Principal Investigator: Michael Raizman, MD         
United States, Michigan
University of Michigan/Kellogg Eye Center Recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Munira Hussain    734-647-8397    hussain@med.umich.edu   
Principal Investigator: Alan Sugar, MD         
Verdier Eye Center 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: Tina McLeod    248-350-1130 ext 304    tmacleod@michigancornea.com   
Principal Investigator: Steve Dunn, MD         
United States, Minnesota
Minnesota Eye Consultants Recruiting
Bloomington, Minnesota, United States, 55431
Contact: Sara Mork    612-813-3608    smmork@mneye.com   
Principal Investigator: David Hardten, MD         
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Diane Vogen    507-538-8119    vogen.diane2@mayo.edu   
Principal Investigator: Sanjay Patel, MD         
United States, Missouri
Mercy Medical Research Institute Recruiting
Springfield, Missouri, United States, 65804
Contact: Crystal Trythall    417-820-7493    Crystal.Trythall@mercy.net   
Principal Investigator: Shachar Tauber, MD         
Ophthalmology Associates Recruiting
St. Louis, Missouri, United States, 63131
Contact: Debi Gravemann    314-966-3377    Debi.Gravemann@youreyedoc.com   
Principal Investigator: Gregg Berdy, MD         
United States, New York
New York Eye and Ear Infirmary Recruiting
New York, New York, United States, 10003
Contact: Kristen Fry    212-505-6550    fryk@earthlink.net   
Principal Investigator: John Seedor, MD         
Cornea Consultants of Albany Recruiting
Slingerlands, New York, United States, 12159
Contact: Kathy Cavanaugh    518-475-1515    kathy.cavanaugh@corneacare.com   
Principal Investigator: Robert Schultze, MD         
United States, Ohio
Cincinnati Eye Institute Recruiting
Cincinnati, Ohio, United States, 45242
Contact: Tracy Cruz    513-569-3676    tcruz@cincinnatieye.com   
Principal Investigator: Michael Nordlund, MD         
University Hospitals Case Medical Center Eye Institute Active, not recruiting
Cleveland, Ohio, United States, 44106
Ohio State Medical Center Recruiting
Columbus, Ohio, United States, 43212
Contact: Andrea Inman    614-293-8117    Andrea.Inman@osumc.edu   
Principal Investigator: Thomas Mauger, MD         
Northeast Ohio Eye Surgeons Recruiting
Kent, Ohio, United States, 44240
Contact: John Valentine    330-678-0201    johnneoes@gmail.com   
Principal Investigator: Marc Jones, MD         
United States, Oregon
Medical Eye Center Recruiting
Medford, Oregon, United States, 97504
Contact: Heather Smith    541-618-1422    HeatherS@medicaleyecenter.com   
Principal Investigator: Matthew Oliva, MD         
Devers Eye Institute Recruiting
Portland, Oregon, United States, 97210
Contact: David Davis-Boozer    503-413-8377    ddboozer@deverseye.org   
Principal Investigator: Mark Terry, MD         
United States, Pennsylvania
Ophthalmic Partners of PA Recruiting
Bala Cynwyd, Pennsylvania, United States, 19053
Contact: Irene Spanelis    484-434-2700    ispanelis@oppdoctors.com   
Principal Investigator: Irving Raber, MD         
Central Pennsylvania Eye Institute Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Miriam Rosenwasser    717-533-5200    mr@cpeye.com   
Principal Investigator: George Rosenwasser, MD         
Sadeer Hannush, MD Recruiting
Langhorne, Pennsylvania, United States, 19047
Contact: Brian Sperling    215-752-8564    sperling8@aol.com   
Principal Investigator: Sadeer B Hannush, MD         
Corneal Associates, PC, Wills Eye Institute Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Sara Rapuano    215-928-3174    sbrapuano@yahoo.com   
Principal Investigator: Kristin Hammersmith, MD         
United States, Texas
Cornea Associates of Texas Recruiting
Dallas, Texas, United States, 75231
Contact: Jennifer Hargrove    214-692-0146 ext 131    jhargrove@corneatexas.com   
Principal Investigator: Tyrone McCall, MD         
Focal Point Vision Recruiting
San Antonio, Texas, United States, 78229
Contact: Ashley Grizzard    210-614-3600    grizzard@focalpointvision.com   
Principal Investigator: Kenneth Maverick, MD         
United States, Utah
University of Utah, Moran Eye Center Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Katie Farnsworth    801-585-6647    Katie.Farnsworth@utah.edu   
Principal Investigator: Mark Mifflin, MD         
United States, Washington
Eye Associates Northwest Recruiting
Seattle, Washington, United States, 98104
Contact: Michelle Corrigan    206-342-6109    mcorrigan@eanw.net   
Principal Investigator: Tom Gillette, MD         
United States, Wisconsin
Dean Medical Center Recruiting
Madison, Wisconsin, United States, 53715
Contact: Michelle Kole    608-282-2275    michelle.kole@deancare.com   
Principal Investigator: Christopher Croasdale, MD         
Sponsors and Collaborators
Case Western Reserve University
Jaeb Center for Health Research
Investigators
Study Chair: Jonathan Lass, MD Case Western Reserve University
Principal Investigator: Allison Edwards, MS Jaeb Center for Health Research
  More Information

Additional Information:
No publications provided

Responsible Party: Jonathan Lass, MD, Charles I Thomas Professor and Chair, Dept. of Ophthalmology & Visual Sciences, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT01537393     History of Changes
Other Study ID Numbers: CPTS, 1U10EY020798-01A1, 1U10EY020797-01A1
Study First Received: February 15, 2012
Last Updated: May 24, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Case Western Reserve University:
cornea
transplant
preservation
endothelial keratoplasty

Additional relevant MeSH terms:
Corneal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on April 17, 2014