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

February 15, 2012
May 24, 2013
March 2012
July 2016   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01537393 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Cornea Preservation Time Study
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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Cornea Tissue Preservation Time
Biological: Cornea tissue transplant
Cornea tissue preserved either 7 or less days or 8 to 14 days.
  • Preservation Time Group 1
    Subjects in this arm will receive cornea tissue preserved for up to 7 days prior to transplant.
    Intervention: Biological: Cornea tissue transplant
  • Preservation Time Group 2
    Subjects in this arm will receive cornea tissue preserved for 8 to 14 days prior to transplant.
    Intervention: Biological: Cornea tissue transplant
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1330
Not Provided
July 2016   (final data collection date for primary outcome measure)

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
Both
30 Years to 90 Years
No
Contact: Loretta Szczotka-Flynn, OD, PhD 216-844-7934 loretta.szczotka@uhhospitals.org
United States
 
NCT01537393
CPTS, 1U10EY020798-01A1, 1U10EY020797-01A1
Yes
Jonathan Lass, MD, Case Western Reserve University
Case Western Reserve University
  • National Eye Institute (NEI)
  • Jaeb Center for Health Research
Study Chair: Jonathan Lass, MD Case Western Reserve University
Principal Investigator: Allison Edwards, MS Jaeb Center for Health Research
Case Western Reserve University
May 2013

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