Glaucoma Drainage Device and Endothelial Cell Density Loss Compare (DECLARE) Trial

青光眼引流装置和内皮细胞密度损失比较（DECLARE）试验

• 批准号: 10554765
• 负责人: Ying Han
• 金额: $ 119.16万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10554765
• 关键词: Address; American; Anterior; Biological Markers; Blindness; California; Caring; Cell Density; Chronic; Ciliary Body; Clinical; Complex; Cornea; Corneal Endothelium; Data; Data Coordinating Center; Devices; Drainage procedure; Endothelial Cells; Eye Movements; Foundations; Funding; Future; Gene Expression; Glaucoma; Goals; Health; Image; Imaging Techniques; Inflammation; Investigation; Iris; Location; Longitudinal Studies; Masks; Mechanics; Medical; Metagenomics; Nature; Operative Surgical Procedures; Ophthalmology; Optics; Outcome; Participant; Patients; Pennsylvania; Pharmaceutical Preparations; Physiologic Intraocular Pressure; Pigments; Positioning Attribute; Postoperative Complications; Postoperative Period; Prospective Studies; RNA; Randomized; Reading; Refractory; Retrospective Studies; Sampling; San Francisco; Silicones; Societies; Specialist; Surveys; Techniques; Time; Touch sensation; Tube; Universities; Visual Acuity; anterior chamber; aqueous; cellular imaging; cohort; comparison control; deep sequencing; design; high resolution imaging; implantation; improved; innovation; interest; novel; preservation; prevent; randomized, clinical trials; surgery outcome; trial comparing

PROJECT SUMMARY/ABSTRACT Glaucoma drainage device (GDD) surgery has gained popularity in managing patients with medically uncontrolled glaucoma. However, one of the major long-term complications of GDD is progressive corneal endothelial cell loss (ECL) leading to corneal decompensation, which requires complex care. Although surgical techniques have been modified to insert the tube into the ciliary sulcus to address this issue, anterior chamber (AC) tube placement remains the preferred location, as there is a lack of convincing data to validate the advantages of sulcus placement. For example, (1) Direct comparison of endothelial cell loss (ECL) after sulcus versus AC tube placement is limited to three retrospective studies; (2) Studies are inconsistent regarding whether intraocular pressure (IOP) and other surgical outcomes are similar after sulcus tube or AC tube placement; (3) Question remains whether a sulcus tube cause more AC microenvironment change due to higher chance of having chronic tube-iris touch than an AC tube, jeopardizing endothelial cell health, IOP control, or other surgical outcomes of the sulcus tube. To answer these questions, we propose a multi-center, outcome-masked clinical trial randomizing 240 subjects to sulcus tube versus AC tube placement. In this trial, we will compare ECL (specific aim 1), IOP control (specific aim 2) and AC microenvironment (specific aim 3) after GDD implantation with tube placement in the ciliary sulcus versus the anterior chamber. In the setting of increased use of GDDs, our proposed trial to identify better approaches to decrease its corneal complications is of substantial interest to both corneal and glaucoma specialists. Department of Ophthalmology at University of California San Francisco (UCSF), Francis I. Proctor Foundation at UCSF, University of Pennsylvania (UPenn), and 4 high-volume centers for GDD implantation will jointly execute this trial. The Department of Ophthalmology at UCSF will serve as Clinical Coordinating Center. UPenn will be the Data Coordinating Center. Francis I. Proctor Foundation will be the imaging reading center and metagenomic RNA deep sequencing analysis (MDS) center. This trial is innovative for a number of reasons including the randomization of surgery (sulcus tube versus AC tube) and application of novel MDS analysis (examining postoperative AC microenvironment), none of which has been prospectively studied before. It is aligned with the priorities of the NEI, studying high- resolution imaging techniques such as endothelial cell imaging and anterior-segment optical coherence 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 important questions presented in this proposal.

项目总结/摘要 青光眼引流装置（GDD）手术在治疗药物依赖性青光眼患者方面已经得到普及。 无法控制的青光眼然而，GDD的主要长期并发症之一是进行性角膜病变， 内皮细胞损失（ECL）导致角膜失代偿，这需要复杂的护理。尽管手术 已经改进了将管插入睫状沟的技术，以解决前房问题， (AC)管放置仍然是首选位置，因为缺乏令人信服的数据来验证 沟放置的优点。例如，（1）直接比较脑沟损伤后的内皮细胞损失（ECL） 与AC管放置的对比仅限于三项回顾性研究;（2）研究在以下方面不一致： 眼内压（IOP）和其他手术结果是否相似后，沟管或AC管 （3）问题仍然存在，是否沟管引起更多的AC微环境变化， 与AC插管相比，慢性插管-虹膜接触的可能性更高，危及内皮细胞健康，IOP 控制，或其他手术结果的沟管。 为了回答这些问题，我们提出了一个多中心，结果盲的临床试验随机240 受试者接受龈沟管与AC管放置。在本试验中，我们将比较ECL（特定目标1）、IOP GDD植入并放置管子后的对照（具体目标2）和AC微环境（具体目标3） 睫状沟与前房的对比在GDD使用增加的情况下，我们建议的试验， 确定减少其角膜并发症的更好方法对于角膜和 青光眼专家 加州圣弗朗西斯科大学（UCSF）眼科学系，弗朗西斯I。普罗克特 基金会在加州大学旧金山分校，宾夕法尼亚大学（UPenn），和4个大容量中心的GDD植入将 共同执行这次审判UCSF眼科系将作为临床协调中心。 宾夕法尼亚大学将成为数据协调中心。弗朗西斯岛普罗克特基金会将成为成像阅读中心 和宏基因组RNA深度测序分析（MDS）中心。 这项试验是创新的，原因有很多，包括手术的随机化（沟管 对比AC管）和应用新型MDS分析（检查术后AC微环境），无 其中的一个已经被前瞻性地研究过了。它与NEI的优先事项保持一致，研究高- 分辨率成像技术，如内皮细胞成像和前段光学相干， 指导术后治疗，并作为未来试验的潜在替代试验终点。这个世界级的团队 的合作者在执行NEI资助的大型眼科试验方面有良好的记录， 能够回答本提案中提出的重要问题。