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Cornea Preservation Time Study (CPTS)

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: NCT01537393
Recruitment Status : Completed
First Posted : February 23, 2012
Results First Posted : April 23, 2018
Last Update Posted : April 23, 2018
Sponsor:
Collaborators:
National Eye Institute (NEI)
Jaeb Center for Health Research
Information provided by (Responsible Party):
Jonathan Lass, MD, Case Western Reserve University

Tracking Information
First Submitted Date  ICMJE February 15, 2012
First Posted Date  ICMJE February 23, 2012
Results First Submitted Date  ICMJE March 14, 2018
Results First Posted Date  ICMJE April 23, 2018
Last Update Posted Date April 23, 2018
Actual Study Start Date  ICMJE April 16, 2012
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 22, 2012)
Corneal Graft Failure [ Time Frame: Participants 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: February 22, 2012)
Endothelial cell density [ Time Frame: 3 years from surgery ]
Endothelial cell density at 3 years from surgery, conditional on graft survival at 3 years from surgery.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cornea Preservation Time Study
Official Title  ICMJE Effect of Corneal Preservation Time on Long-Term Graft Success
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Cornea Preservation Time
  • Endothelial Keratoplasty
  • Transplant Success
  • Endothelial Cell Density
Intervention  ICMJE
  • Biological: Cornea tissue transplant
    Cornea tissue preserved 0 to 7 days
  • Biological: Cornea tissue transplant
    Cornea tissue preserved 8 to 14 days.
Study Arms  ICMJE
  • 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.
    Intervention: Biological: Cornea tissue transplant
  • 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.
    Intervention: Biological: Cornea tissue transplant
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2018)
1174
Original Estimated Enrollment  ICMJE
 (submitted: February 22, 2012)
1330
Actual Study Completion Date  ICMJE June 30, 2017
Actual Primary Completion Date June 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01537393
Other Study ID Numbers  ICMJE CPTS
1U10EY020798-01A1 ( U.S. NIH Grant/Contract )
1U10EY020797-01A1 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jonathan Lass, MD, Case Western Reserve University
Study Sponsor  ICMJE Case Western Reserve University
Collaborators  ICMJE
  • National Eye Institute (NEI)
  • Jaeb Center for Health Research
Investigators  ICMJE
Study Chair: Jonathan Lass, MD Case Western Reserve University
Principal Investigator: Allison Ayala, MS Jaeb Center for Health Research
PRS Account Case Western Reserve University
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP