title: Cornea preservation time study: methods and potential impact on the cornea donor pool in the United States.
abstract: OBJECTIVE
  The aim of this study was to describe the aims, methods, donor and recipient cohort characteristics, and potential impact of the Cornea Preservation Time Study (CPTS).
  
  
  METHODS
  The CPTS is a randomized clinical trial conducted at 40 clinical sites (70 surgeons) designed to assess the effect of donor cornea preservation time (PT) on graft survival 3 years after Descemet stripping automated endothelial keratoplasty (DSAEK). Eyes undergoing surgery for Fuchs endothelial corneal dystrophy or pseudophakic/aphakic corneal edema were randomized to receive donor corneas stored ≤7 days or 8 to 14 days. Donor and patient characteristics, tissue preparation and surgical parameters, recipient and donor corneal stroma clarity, central corneal thickness, intraocular pressure, complications, and a reading center-determined central endothelial cell density were collected. Surveys were conducted to evaluate pre-CPTS PT practices.
  
  
  RESULTS
  The 1330 CPTS donors were: 49% >60 years old, 27% diabetic, had a median eye bank-determined screening endothelial cell density of 2688 cells/mm, and 74% eye bank prepared for DSAEK. A total of 1090 recipients (1330 eyes including 240 bilateral cases) had: median age of 70 years, were 60% female, 90% white, 18% diabetic, 52% phakic, and 94% had Fuchs endothelial corneal dystrophy. Before the CPTS, 19 eye banks provided PT data on 20,852 corneas domestically placed for DSAEK in 2010 to 2011; 96% were preserved ≤7 days. Of 305 American Academy of Ophthalmology members responding to a pre-CPTS survey, 233 (76%) set their maximum PT preference at 8 days or less.
  
  
  CONCLUSIONS
  The CPTS will increase understanding of factors related to DSAEK success and, if noninferiority of longer PT is shown, will have great potential to extend the available pool of endothelial keratoplasty donors.Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifier: NCT01537393.
authors: *Department of Ophthalmology and Visual Sciences, Case Western Reserve University and University Hospitals Eye Institute, Cleveland, OH; †Jaeb Center for Health Research, Tampa, FL; ‡Jules Stein Eye Institute, University of California, Los Angeles, Los Angeles, CA; §Eye Associates Northwest, Seattle, WA; ¶Michigan Cornea Consultants, PC, Southfield, MI; ‖Cornea Associates of Texas, Dallas, TX; **Mid Atlantic Cornea Consultants, Baltimore, MD; ††Central Pennsylvania Eye Center, Hershey, PA; ‡‡Midwest Eye-Banks, Ann Arbor, MI; §§Devers Eye Institute, Portland, OR; and ¶¶Verdier Eye Center, Grand Rapids, MI.
authors: Jonathan H
authors: JH
authors: Lass
authors: Loretta B
authors: LB
authors: Szczotka-Flynn
authors: Allison R
authors: AR
authors: Ayala
authors: Beth A
authors: BA
authors: Benetz
authors: Robin L
authors: RL
authors: Gal
authors: Anthony J
authors: AJ
authors: Aldave
authors: Michelle M
authors: MM
authors: Corrigan
authors: Steven P
authors: SP
authors: Dunn
authors: Ty L
authors: TL
authors: McCall
authors: Sudeep
authors: S
authors: Pramanik
authors: George O
authors: GO
authors: Rosenwasser
authors: Kevin W
authors: KW
authors: Ross
authors: Mark A
authors: MA
authors: Terry
authors: David D
authors: DD
authors: Verdier
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002452:Cell Count; D002648:Child; D015715:Corneal Edema / Q000503:physiopathology / Q000601:surgery; D063171:Corneal Pachymetry; D015925:Cryopreservation / Q000379:methods*; D003886:Descemet Membrane; D057111:Descemet Stripping Endothelial Keratoplasty / Q000706:statistics & numerical data*; D004728:Endothelium, Corneal; D005125:Eye Banks / Q000706:statistics & numerical data; D005260:Female; D005642:Fuchs' Endothelial Dystrophy / Q000503:physiopathology / Q000601:surgery; D006085:Graft Survival / Q000502:physiology*; D006801:Humans; D007429:Intraocular Pressure / Q000502:physiology; D008297:Male; D008875:Middle Aged; D009926:Organ Preservation / Q000379:methods*; D013997:Time Factors; D014019:Tissue Donors / Q000706:statistics & numerical data*; D066027:Transplant Recipients; D014481:United States