Price Marianne O, Szczotka-Flynn Loretta B, Bauza Colleen E, Reed Zachariah W, Benetz Beth Ann, Greiner Mark A, Verdier David D, Soper Mark C, Titus Michael S, Monnier Vincent M, Arafah Baha M, Kollman Craig, Beck Roy W, Lass Jonathan H
Cornea Research Foundation of America, Indianapolis, IN.
Department of Ophthalmology and Visual Sciences, Case Western Reserve University School of Medicine, University Hospitals Eye Institute, Cleveland, OH.
Cornea. 2025 Jan 9. doi: 10.1097/ICO.0000000000003776.
Describe aims, methods, characteristics of donors, donor corneas and recipients, and potential impact of the Diabetes Endothelial Keratoplasty Study (DEKS).
The DEKS is a randomized, clinical trial to assess graft success and endothelial cell density (ECD) 1 year after Descemet membrane endothelial keratoplasty (DMEK) using corneas from donors with versus without diabetes in a 1:2 minimization assignment. Diabetes severity in the donor is assessed by medical history, postmortem HbA1c, and donor skin advanced glycation end-products and oxidation markers. A central image analysis reading center assesses baseline donor, 1-month and 1-year postoperative ECD.
The DEKS used corneas from 1154 donors for 1421 DMEK procedures on 1097 participants (324 bilateral) at 28 clinical sites. Forty-eight tissue preparations failed (3%). Mean donor age was 65 years; mean eye bank-determined screening ECD was 2709 cells/mm2. Ultimately, 106 (9%) of 1154 donors without diabetes history were classified as diabetic based on postmortem HbA1c ≥6.5%, and 509 (36%) of 1421 donor lenticules were classified as coming from diabetic donors. Recipients were 58% female, 96% White, and 53% phakic. Study eyes were treated for Fuchs endothelial corneal dystrophy (96%), pseudophakic corneal edema (2%), and failed endothelial keratoplasty (2%). Mean recipient age was 70 years; 21% had diabetes history and 26 (2%) had central laboratory determined HbA1c ≥6.5% without diabetes history.
The DEKS will increase understanding of factors related to DMEK success while determining whether diabetes and/or diabetes severity in the donor and/or recipient adversely affects graft success and endothelial cell loss.
描述糖尿病性内皮角膜移植术研究（DEKS）的目的、方法、供体、供体角膜和受体的特征以及潜在影响。
DEKS是一项随机临床试验，采用1:2最小化分配，使用患有和未患有糖尿病的供体角膜进行后弹力层内皮角膜移植术（DMEK），评估术后1年的移植物成功率和内皮细胞密度（ECD）。通过病史、死后糖化血红蛋白（HbA1c）以及供体皮肤晚期糖基化终产物和氧化标志物评估供体的糖尿病严重程度。一个中央图像分析阅读中心评估基线供体、术后1个月和1年的ECD。
DEKS在28个临床地点使用了来自1154名供体的角膜，为1097名参与者（324名双侧）进行了1421例DMEK手术。48份组织制备失败（3%）。供体平均年龄为65岁；眼库确定的平均筛查ECD为2709个细胞/mm²。最终，1154名无糖尿病病史的供体中，有106名（9%）根据死后HbA1c≥6.5%被归类为糖尿病患者，1421个供体晶状体片中的509个（36%）被归类为来自糖尿病供体。受体中女性占58%，白人占96%，有晶状体眼占53%。研究眼治疗的疾病包括Fuchs内皮角膜营养不良（96%）、人工晶状体性角膜水肿（2%）和内皮角膜移植失败（2%）。受体平均年龄为70岁；21%有糖尿病病史，26名（2%）无糖尿病病史但中央实验室测定的HbA1c≥6.5%。
DEKS将增进对与DMEK成功相关因素的理解，同时确定供体和/或受体中的糖尿病和/或糖尿病严重程度是否会对移植物成功和内皮细胞丢失产生不利影响。
