Descemet Endothelial Thickness Comparison Trial (DETECT)

后弹力层内皮厚度比较试验 (DETECT)

基本信息

批准号：
10088896
负责人：
Jennifer Rose-Nussbaumer
金额：
$ 6.32万
依托单位：
KAISER FOUNDATION RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-04-01 至 2021-09-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10088896
关键词：
Address Adjuvant Americas Anterior Apoptosis California Cell Count Cell Density Cell Proliferation Cells Clinical Trials Complication Consensus Cornea Corneal edema Data Descemet&apos s membrane Disease Endophthalmitis Endothelial Cells Endothelium Eye Banks Failure Fuchs&apos Endothelial Dystrophy Funding Future Graft Rejection Graft Survival Health Health Sciences Human Image Imaging Techniques In Vitro Keratoplasty Lamellar Keratoplasty Maintenance Maryland Masks Medical Modeling Operative Surgical Procedures Ophthalmology Optics Oregon Outcome Participant Patients Penetrating Keratoplasty Pharmaceutical Preparations Placebos Play Positioning Attribute Postoperative Period Randomized Randomized Clinical Trials Recovery Research Design Rho-associated kinase Risk Role Safety Series Societies Surgeon Techniques Testing Therapeutic Exploratory Study Therapeutic Trials Thick Time Topical application Transplant Surgeon Transplantation Transplantation Surgery United States Universities Vision Visual Visual Acuity anterior chamber arm cellular imaging cost design endothelial dysfunction graft failure high resolution imaging improved improved outcome individual patient inhibitor/antagonist innovation kinase inhibitor novel prevent treatment group

项目摘要

PROJECT SUMMARY/ABSTRACT Although endothelial keratoplasty is one of the most commonly performed transplant surgeries, it is unknown which technique provides optimal visual acuity outcomes while minimizing endothelial cell loss and complications. Post-operative endothelial cell counts have been shown to correlate with risk of subsequent graft failure, with significant cost to individual patients and society. Topical rho-kinase inhibitors such as ripasudil 0.4% may play an important role in maintaining endothelial health after keratoplasty. Here we propose the Descemet Endothelial Thickness Comparison Trial (DETECT), a randomized, outcome- masked, multi-center, four-arm clinical trial with a 2x2 factorial design. The purpose of this study is to determine differences in visual outcomes between two types of corneal transplant surgeries, ultrathin Descemet stripping automated endothelial keratoplasty (UT-DSAEK) and Descemet membrane endothelial keratoplasty (DMEK), and to determine the effect of rho-kinase inhibitors on endothelial cell counts after keratoplasty. Patients presenting to Oregon Health & Science University, Stanford University, NorthShore University HealthSystem, University of Maryland, and to Kaiser Permanente Northern California with endothelial dysfunction who are good candidates for either UT-DSAEK or DMEK will be eligible for inclusion. Participants will be randomized to one of four treatment groups in this 2x2 factorial design study: Endothelial Keratoplasty UT-DSAEK DMEK Adjuvant Topical Medication Ripasudil 0.4% UT-DSAEK + 0.4% ripasudil DMEK + 0.4% ripasudil Placebo UT-DSAEK + placebo DMEK + placebo This approach is innovative for a number of reasons including its testing of a novel treatment, ripasudil 0.4%, and the randomization of surgery, which is relatively rare. It is aligned with the priorities of the NEI, studying new high-resolution imaging techniques such as endothelial cell imaging, anterior-segment optical coherence and Pentacam Scheimflug imaging, to guide post-operative treatment and as potential surrogate trial endpoints in future trials. This world class team of collaborators have a proven track record for executing large NEI- funded trials in ophthalmology, and are well positioned to answer the two important questions presented in this proposal.

项目概要/摘要尽管内皮角膜移植术是最常进行的移植手术之一，但目前尚不清楚哪种技术可提供最佳的视力结果，同时最大限度地减少内皮细胞损失和并发症。术后内皮细胞计数已被证明与后续风险相关移植失败，给患者个人和社会带来巨大成本。局部用 rho 激酶抑制剂，例如 0.4%的里帕舒地尔可能在角膜移植术后维持内皮健康方面发挥重要作用。在此，我们提出后弹力层内皮厚度比较试验 (DETECT)，这是一项随机、结果- 采用 2x2 析因设计的匿名、多中心、四组临床试验。本研究的目的是确定两种类型的角膜移植手术（超薄）之间视觉结果的差异后弹力层剥离自动内皮角膜移植术 (UT-DSAEK) 和后弹力层内皮移植术角膜移植术 (DMEK)，并确定 rho 激酶抑制剂对术后内皮细胞计数的影响角膜移植术。就诊于俄勒冈健康与科学大学、斯坦福大学北岸分校的患者 University HealthSystem、马里兰大学和北加州 Kaiser Permanente 适合 UT-DSAEK 或 DMEK 候选者的内皮功能障碍患者将有资格纳入。在这项 2x2 析因设计研究中，参与者将被随机分配到四个治疗组之一：内皮角膜移植术 UT-DSAEK DMEK 佐剂专题药物利帕舒地尔 0.4% UT-DSAEK + 0.4% 瑞帕舒地尔二甲基甲酰胺+ 0.4% 瑞帕舒地尔安慰剂 UT-DSAEK + 安慰剂二甲基甲酰胺+ 安慰剂这种方法具有创新性，原因有很多，包括测试了一种新的治疗方法，即 0.4% 的瑞帕舒地尔，以及手术的随机化，这种情况相对较少。它与 NEI 的优先事项一致，研究新的高分辨率成像技术，例如内皮细胞成像、眼前段光学相干和 Pentacam Schimflug 成像，指导术后治疗并作为潜在的替代试验终点在未来的试验中。这个世界级的合作团队在执行大型 NEI 方面拥有良好的记录资助了眼科试验，并且有能力回答本报告中提出的两个重要问题提议。