Cornea Preservation Time Study (CPTS)

April 19, 2018 updated by: Jonathan Lass, MD, Case Western Reserve University

Effect of Corneal Preservation Time on Long-Term Graft Success

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1174

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States, 90211
        • Keck Medical Center
      • Los Angeles, California, United States, 90095
        • Jules Stein Eye Institute
      • San Diego, California, United States, 92103
        • Eye Care of San Diego
      • San Francisco, California, United States, 94110
        • University of California, San Francisco
    • Florida
      • Miami, Florida, United States, 33136
        • Bascom Palmer Eye Institute
      • Sarasota, Florida, United States, 34239
        • Center For Sight
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Woolfson Eye Institute
      • Atlanta, Georgia, United States, 30339
        • Eye Consultants of Atlanta
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois Eye and Eye
      • Glenview, Illinois, United States, 60026
        • NorthShore University Health System
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • University of Kentucky Ophthalmology
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Mid-Atlantic Cornea Consultants
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins/Wilmer Eye Institute
      • Owings Mills, Maryland, United States, 21117
        • Eye Consultants of Maryland
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • University of Michigan/Kellogg Eye Center
      • Grand Rapids, Michigan, United States, 49546
        • Verdier Eye Center
      • Southfield, Michigan, United States, 48034
        • Michigan Cornea Consultants
    • Minnesota
      • Bloomington, Minnesota, United States, 55431
        • Minnesota Eye Consultants
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63131
        • Ophthalmology Associates
      • Springfield, Missouri, United States, 65804
        • Mercy Medical Research Institute
    • New York
      • New York, New York, United States, 10003
        • New York Eye and Ear Infirmary
      • Slingerlands, New York, United States, 12159
        • Cornea Consultants of Albany
    • Ohio
      • Cincinnati, Ohio, United States, 45242
        • Cincinnati Eye Institute
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center Eye Institute
      • Columbus, Ohio, United States, 43212
        • Ohio State Medical Center
      • Kent, Ohio, United States, 44240
        • Northeast Ohio Eye Surgeons
    • Oregon
      • Medford, Oregon, United States, 97504
        • Medical Eye Center
      • Portland, Oregon, United States, 97210
        • Devers Eye Institute
    • Pennsylvania
      • Bala-Cynwyd, Pennsylvania, United States, 19053
        • Ophthalmic Partners of PA
      • Hershey, Pennsylvania, United States, 17033
        • Central Pennsylvania Eye Institute
      • Langhorne, Pennsylvania, United States, 19047
        • Sadeer Hannush, MD
      • Philadelphia, Pennsylvania, United States, 19107
        • Corneal Associates, PC, Wills Eye Institute
    • Texas
      • Dallas, Texas, United States, 75231
        • Cornea Associates of Texas
      • San Antonio, Texas, United States, 78229
        • Focal Point Vision
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah, Moran Eye Center
    • Washington
      • Seattle, Washington, United States, 98104
        • Eye associates Northwest
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Dean Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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. Endothelial keratoplasty (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 Fuchs endothelial corneal dystrophy (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 Penetrating Keratoplasty (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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 0-7d Preservation Time Group
Subjects in this arm will receive cornea tissue transplant with cornea tissue preserved for 0 to 7 days prior to transplant.
Biological: Cornea tissue transplant
Cornea tissue preserved 0 to 7 days
Biological: Cornea tissue transplant
Cornea tissue preserved 8 to 14 days.
Other: 8-14d Preservation Time Group
Subjects in this arm will receive cornea tissue transplant with cornea tissue preserved for 8 to 14 days prior to transplant.
Biological: Cornea tissue transplant
Cornea tissue preserved 0 to 7 days
Biological: Cornea tissue transplant
Cornea tissue preserved 8 to 14 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery
Time Frame: Study eye will be assessed for this outcome for 3 years following surgery

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.
Study eye will be assessed for this outcome for 3 years following surgery
Endothelial Cell Density (ECD)
Time Frame: 3 years from surgery
Endothelial cell density at 3 years from surgery, conditional on graft survival at 3 years from surgery.
3 years from surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Case Western Reserve University

Collaborators

National Eye Institute (NEI)
Jaeb Center for Health Research

Investigators

  • Principal Investigator: Allison Ayala, MS, Jaeb Center for Health Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 16, 2012

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

February 15, 2012

First Submitted That Met QC Criteria

February 22, 2012

First Posted (Estimate)

February 23, 2012

Study Record Updates

Last Update Posted (Actual)

April 23, 2018

Last Update Submitted That Met QC Criteria

April 19, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPTS
  • 1U10EY020798-01A1 (U.S. NIH Grant/Contract)
  • 1U10EY020797-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cornea Preservation Time

Clinical Trials on Cornea tissue transplant

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe