Preparation and Planning for the Prospective Randomized Image-guided Ophthalmic Surgery Clinical Trials

前瞻性随机图像引导眼科手术临床试验的准备和规划

• 批准号: 9789898
• 负责人: Justis Ehlers
• 金额: $ 24万
• 依托单位: CLEVELAND CLINIC LERNER COM-CWRU
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-30 至 2020-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9789898
• 关键词: Adjuvant; Anatomy; Biometry; Clinic; Clinical; Clinical Management; Clinical Research; Clinical Trials; Clinical Trials Design; Conventional Surgery; Cost utility; Data Analyses; Databases; Decision Making; Development Plans; Diagnosis; Disease; Documentation; Dyes; Endpoint Determination; Enrollment; Epiretinal Membrane; Evaluation; Eye; Feedback; Future; Goals; Grant; Image; Image-Guided Surgery; Imaging technology; Infrastructure; Institutes; Interview; Investigational Drugs; Lead; Macular Hole; Medicine; Membrane; Monitor; Multicenter Trials; Operative Surgical Procedures; Optical Coherence Tomography; Outcome; Patient Care; Patients; Positioning Attribute; Postoperative Period; Preparation; Procedures; Prone Position; Prospective Studies; Protocols documentation; Quality of life; Randomized; Randomized Controlled Clinical Trials; Randomized Controlled Trials; Regimen; Research; Research Activity; Research Design; Research Infrastructure; Research Personnel; Resolution; Resources; Retina; Retinal; Retinal Diseases; Role; Safety; Sample Size; Schedule; Site; Structure; Surgeon; Techniques; Technology; Testing; Training; base; cost; data management; design; disorder of macula of retina; experience; follow-up; health care economics; image guided; improved; macula; outcome forecast; personalized care; primary endpoint; prospective; protocol development; repaired; research study; secondary endpoint; success; surgery outcome; surgical research; trial design

Project Summary Image-guided surgery with intraoperative optical coherence tomography (OCT) has the potential to have a significant impact on surgical efficiency, patient quality-of-life, surgical safety, and overall surgical outcomes in two common surgical vitreoretinal disorders: macular hole and epiretinal membranes. OCT has revolutionized the clinical management of retinal diseases. The high-resolution cross-sectional information that is provided by OCT now is the mainstay for evaluating anatomic distortion, confirming diagnosis, and gauging prognosis for an extensive list of retinal conditions, particularly vitreoretinal interface disorders, such as macular hole and epiretinal membranes. Utilizing OCT to provide surgical guidance and feedback is a natural extension of this technology. Multiple prospective studies suggest that intraoperative OCT may have a significant impact on surgical decision-making, including key metrics in surgical efficiency (e.g., reducing unnecessary surgical manipulations). This research activity will focus on developing two clinical trials focused on establishing the role of intraoperative OCT in vitreoretinal macular surgery and will be led by Justis P. Ehlers, MD, of the Cleveland Clinic Cole Eye Institute. Dr. Ehlers is a highly trained retina surgeon with extensive experience in the field of intraoperative OCT and in clinical trial execution. Dr. Ehlers has led multiple clinical trials, including the successful completion of his own investigational new drug (IND) trial and the 2 largest prospective clinical research studies on intraoperative OCT completed to date. This 2-year planning grant will facilitate optimal clinical trial design, team-building, and infrastructure support needed to execute these trials with success and efficiency. This R34 clinical trial planning activity will focus on 2 primary surgical procedures: image-guided epiretinal membrane peeling and macular hole repair with individualized positioning based on intraoperative OCT feedback. Although unique, these 2 trials have significant overlap that facilitates designing both trials under this single R34 activity. The 2 trials will utilize the same sites, research coordinators, and investigators. These resource overlaps will greatly enhance the efficiency of protocol development and developing safety protocols. Utilizing nearly a decade of experience with intraoperative OCT and clinical trial execution, Dr. Ehlers is well-equipped to lead this clinical trial team. In order to enable the successful execution of this activity and the subsequent clinical trials, Dr. Ehlers has assembled a group of experts in the field of clinical research, vitreoretinal surgery, biostatistics, imaging, and value-based medicine. These experts will form the Image-guided Surgery Study Group to facilitate successful planning and trial design over the course of these 2 years. In addition to this group of experts, Dr. Ehlers has also developed strong partnerships that will facilitate the success of these clinical trials. The primary goals of these clinical trials will be to evaluate image-guided surgery with intraoperative OCT for its role in personalized surgery and to define the role for intraoperative OCT in macular surgery based on surgical efficiency, outcomes and value. !

项目摘要 术中光学相干断层扫描（OCT）的图像引导手术具有潜在的 对手术效率、患者生活质量、手术安全性和总体手术结局有显著影响， 两种常见的手术玻璃体视网膜疾病：黄斑裂孔和视网膜前膜。OCT彻底改变了 视网膜疾病的临床管理。高分辨率的横截面信息由 OCT现在是评估解剖变形，确认诊断和衡量预后的主要方法。 广泛的视网膜病症，特别是玻璃体视网膜界面病症，如黄斑裂孔和视网膜脱离， 视网膜前膜利用OCT提供手术指导和反馈是这一点的自然延伸 技术.多项前瞻性研究表明，术中OCT可能对 手术决策，包括手术效率的关键指标（例如，减少不必要的手术 操纵）。这项研究活动将侧重于开发两项临床试验，重点是建立 术中OCT在玻璃体视网膜黄斑手术中的作用，并将由Justis P. Ehlers，MD， 克利夫兰诊所科尔眼科研究所。Ehlers博士是一位训练有素的视网膜外科医生， 术中OCT和临床试验执行领域。埃勒斯博士领导了多项临床试验，包括 他成功完成了自己的研究性新药（IND）试验和2个最大的前瞻性临床试验， 迄今为止完成的术中OCT研究。这项为期两年的规划补助金将促进最佳的 成功执行这些试验所需的临床试验设计、团队建设和基础设施支持， 效率该R34临床试验计划活动将重点关注2种主要外科手术：图像引导 视网膜前膜剥除及黄斑裂孔修补术术中个体化定位 OCT反馈。虽然这两项试验是独特的，但它们有显著的重叠，这有助于设计两项试验 在这个单一的R34活动下。这2项试验将使用相同的研究中心、研究协调员和研究者。 这些资源重叠将大大提高协议开发的效率和开发的安全性 协议.利用近十年的术中OCT和临床试验执行经验，Dr. Ehlers有能力领导这个临床试验团队。为了使这一计划能够成功执行， 活动和随后的临床试验，Ehlers博士召集了一组临床领域的专家， 研究、玻璃体视网膜手术、生物统计学、成像和基于价值的医学。这些专家将组成 图像引导手术研究组，以促进这2个过程中的成功规划和试验设计 年除了这个专家组，埃勒斯博士还建立了强有力的伙伴关系， 这些临床试验的成功这些临床试验的主要目标将是评估图像引导的 术中OCT在个性化手术中的作用，并定义术中OCT的作用。 OCT在黄斑手术中的手术效率、疗效及价值。 !