角膜保存时间研究：方法及其对美国角膜供体库的潜在影响。
Cornea preservation time study: methods and potential impact on the cornea donor pool in the United States.
作者信息
Lass Jonathan H, Szczotka-Flynn Loretta B, Ayala Allison R, Benetz Beth A, Gal Robin L, Aldave Anthony J, Corrigan Michelle M, Dunn Steven P, McCall Ty L, Pramanik Sudeep, Rosenwasser George O, Ross Kevin W, Terry Mark A, Verdier David D
机构信息
*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.
出版信息
Cornea. 2015 Jun;34(6):601-8. doi: 10.1097/ICO.0000000000000417.
PURPOSE
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.
目的
本研究旨在描述角膜保存时间研究（CPTS）的目的、方法、供体和受体队列特征以及潜在影响。
方法
CPTS是一项在40个临床地点（70名外科医生）开展的随机临床试验，旨在评估供体角膜保存时间（PT）对深板层角膜内皮移植术（DSAEK）后3年移植存活率的影响。因Fuchs内皮性角膜营养不良或人工晶状体眼/无晶状体眼角膜水肿而接受手术的眼睛被随机分组，分别接受保存时间≤7天或8至14天的供体角膜。收集供体和患者特征、组织制备和手术参数、受体和供体角膜基质清晰度、中央角膜厚度、眼压、并发症以及由阅读中心确定的中央内皮细胞密度。进行了调查以评估CPTS前的PT实践。
结果
1330名CPTS供体中：49%年龄>60岁，27%患有糖尿病，眼库确定的筛查内皮细胞密度中位数为2688个细胞/mm，74%的眼库为DSAEK制备角膜。共有1090名受体（1330只眼，包括240例双眼病例），年龄中位数为70岁，60%为女性，90%为白人，18%患有糖尿病，52%为有晶状体眼，94%患有Fuchs内皮性角膜营养不良。在CPTS之前，19个眼库提供了2010年至2011年国内用于DSAEK的20852只角膜的PT数据；96%的角膜保存时间≤7天。在对CPTS前调查做出回应的305名美国眼科学会成员中，233名（76%）将其最大PT偏好设定为8天或更短。
结论
CPTS将增进对与DSAEK成功相关因素的理解，如果显示较长PT无劣势，则将有很大潜力扩大内皮角膜移植供体库。临床试验注册网址：http://www.clinicaltrials.gov。唯一标识符：NCT01537393。
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