Clinical trial NCT01537393: Cornea Preservation Time Study
Official title: Effect of Corneal Preservation Time on Long-Term Graft Success
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cornea Preservation Time
Endothelial Keratoplasty
Transplant Success
Endothelial Cell Density
Keywords: cornea
transplant
preservation
endothelial keratoplasty
Lead sponsor: Case Western Reserve University
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
name: Jaeb Center for Health Research
First posted: 2012-02-23
Enrollment: 1174
Sex: ALL
Minimum age (years): 30
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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. 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

Primary outcomes:
measure: Number of Eyes With Corneal Graft Failure Within 3 Years of Surgery
timeFrame: Study eye will be assessed for this outcome for 3 years following surgery
measure: Endothelial Cell Density (ECD)
timeFrame: 3 years from surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Keck Medical Center
state: California
city: Los Angeles
country: United States
facility: Jules Stein Eye Institute
state: California
city: San Diego
country: United States
facility: Eye Care of San Diego
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Miami
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Sarasota
country: United States
facility: Center for Sight
state: Florida
city: Atlanta
country: United States
facility: Woolfson Eye Institute
state: Georgia
city: Atlanta
country: United States
facility: Eye Consultants of Atlanta
state: Georgia
city: Chicago
country: United States
facility: University of Illinois Eye and Eye
state: Illinois
city: Glenview
country: United States
facility: NorthShore University Health System
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky Ophthalmology
state: Kentucky
city: Baltimore
country: United States
facility: Mid-Atlantic Cornea Consultants
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins/Wilmer Eye Institute
state: Maryland
city: Owings Mills
country: United States
facility: Eye Consultants of Maryland
state: Maryland
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan/Kellogg Eye Center
state: Michigan
city: Grand Rapids
country: United States
facility: Verdier Eye Center
state: Michigan
city: Southfield
country: United States
facility: Michigan Cornea Consultants
state: Michigan
city: Bloomington
country: United States
facility: Minnesota Eye Consultants
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Springfield
country: United States
facility: Mercy Medical Research Institute
state: Missouri
city: New York
country: United States
facility: New York Eye and Ear Infirmary
state: New York
city: Slingerlands
country: United States
facility: Cornea Consultants of Albany
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center Eye Institute
state: Ohio
city: Columbus
country: United States
facility: Ohio State Medical Center
state: Ohio
city: Kent
country: United States
facility: Northeast Ohio Eye Surgeons
state: Ohio
city: Medford
country: United States
facility: Medical Eye Center
state: Oregon
city: Portland
country: United States
facility: Devers Eye Institute
state: Oregon
city: Bala-Cynwyd
country: United States
facility: Ophthalmic Partners of PA
state: Pennsylvania
city: Hershey
country: United States
facility: Central Pennsylvania Eye Institute
state: Pennsylvania
city: Langhorne
country: United States
facility: Sadeer Hannush, MD
state: Pennsylvania
city: Philadelphia
country: United States
facility: Corneal Associates, PC, Wills Eye Institute
state: Pennsylvania
city: Dallas
country: United States
facility: Cornea Associates of Texas
state: Texas
city: San Antonio
country: United States
facility: Focal Point Vision
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah, Moran Eye Center
state: Utah
city: Seattle
country: United States
facility: Eye Associates Northwest
state: Washington
city: Madison
country: United States
facility: Dean Medical Center
state: Wisconsin
Study officials:
affiliation: Case Western Reserve University
name: Jonathan Lass, MD
role: STUDY_CHAIR
affiliation: Jaeb Center for Health Research
name: Allison Ayala, MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rosenwasser GO, Szczotka-Flynn LB, Ayala AR, Liang W, Aldave AJ, Dunn SP, McCall T, Navarro LC, Pramanik S, Ross KW, Stulting RD, Terry MA, Tu EY, Verdier DD, Kollman C, Gal RL, Beck RW, Lass JH; Cornea Preservation Time Study Group. Effect of Cornea Preservation Time on Success of Descemet Stripping Automated Endothelial Keratoplasty: A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Dec 1;135(12):1401-1409. doi: 10.1001/jamaophthalmol.2017.4989.
citation: Lass JH, Benetz BA, Verdier DD, Szczotka-Flynn LB, Ayala AR, Liang W, Aldave AJ, Dunn SP, McCall T, Mian SI, Navarro LC, Patel SV, Pramanik S, Rosenwasser GO, Ross KW, Terry MA, Kollman C, Gal RL, Beck RW; Cornea Preservation Time Study Group. Corneal Endothelial Cell Loss 3 Years After Successful Descemet Stripping Automated Endothelial Keratoplasty in the Cornea Preservation Time Study: A Randomized Clinical Trial. JAMA Ophthalmol. 2017 Dec 1;135(12):1394-1400. doi: 10.1001/jamaophthalmol.2017.4970.
citation: Lass JH, Bailey RJ, Szczotka-Flynn LB, Benetz BA, Soper M, Titus MS, Kollman C, Beck RW; Cornea Preservation Time Study Group. Comparison of Graft Outcomes Reusing Original Intermediate-Term Cold Storage Solution for Entire Corneal Donor Storage Period With Exchanged Fresh Storage Solution After Donor Preparation in the Cornea Preservation Time Study. Cornea. 2022 Dec 1;41(12):1539-1544. doi: 10.1097/ICO.0000000000003108. Epub 2022 Sep 9.
citation: Lass JH, Szczotka-Flynn LB, Ayala AR, Benetz BA, Gal RL, Aldave AJ, Corrigan MM, Dunn SP, McCall TL, Pramanik S, Rosenwasser GO, Ross KW, Terry MA, Verdier DD; Writing Committee for the Cornea Preservation Time Study Group. Cornea preservation time study: methods and potential impact on the cornea donor pool in the United States. Cornea. 2015 Jun;34(6):601-8. doi: 10.1097/ICO.0000000000000417.