PDF(Pubmed)
Abstract：
BACKGROUND: Minimally invasive glaucoma surgery (MIGS) is a new class of surgeries, which combines moderate to high success rates and a high safety profile. Bent Ab interno Needle Goniotomy (BANG) and Gonioscopy-Assisted Transluminal Trabeculotomy (GATT) are two low-cost MIGS procedures that communicate the anterior chamber to Schlemm\'s canal. Most of the available publications on MIGS are either case series or retrospective studies, with different study protocols. The aim of this manuscript is to describe a randomized clinical trial (RCT) protocol to compare the long-term intraocular pressure (IOP) control and the safety of both procedures in eyes with primary open-angle glaucoma.
METHODS: This is a parallel, double-arm, single-masked RCT that includes pseudophakic primary open-angle glaucoma (POAG) eyes. After inclusion criteria, medications will be washed out to verify baseline IOP before surgery. Patients will be randomized to BANG or GATT using a sealed envelope. Follow-up visits will be 1, 7, 15, 30, 60, 90, 180, 330 and 360 days after surgery. On PO330, a new medication washout will be done. The main outcome is the IOP reduction following the procedures. Complimentary evaluation of functional and structural parameters, safety, and quality of life will be done after 30, 90, 180, and 360 days.
CONCLUSIONS: Our study was designed to compare the long-term efficacy and safety of two low-cost MIGS. Most of the published studies on this subject are case series or retrospective cohorts, with different study protocols, which included different types and severities of glaucomas, combined with cataract extraction. Our study only included mild to moderate POAG eyes, with previous successful cataract extraction. Moreover, it provides a standardized protocol that could be replicated in future studies investigating various types of MIGS. This would allow comparison between different techniques in terms of efficacy, safety, and patients\' quality of life.
BACKGROUND: Retrospectively registered at the Registro Brasileiro de Ensaios Clínicos (ReBEC) platform RBR-268ms5y . Registered on July 29, 2023. The study was approved by the Ethics Committee of the University of Campinas, Brazil.
METHODS: This is a parallel, double-arm, single-masked RCT that includes pseudophakic primary open-angle glaucoma (POAG) eyes. After inclusion criteria, medications will be washed out to verify baseline IOP before surgery. Patients will be randomized to BANG or GATT using a sealed envelope. Follow-up visits will be 1, 7, 15, 30, 60, 90, 180, 330 and 360 days after surgery. On PO330, a new medication washout will be done. The main outcome is the IOP reduction following the procedures. Complimentary evaluation of functional and structural parameters, safety, and quality of life will be done after 30, 90, 180, and 360 days.
CONCLUSIONS: Our study was designed to compare the long-term efficacy and safety of two low-cost MIGS. Most of the published studies on this subject are case series or retrospective cohorts, with different study protocols, which included different types and severities of glaucomas, combined with cataract extraction. Our study only included mild to moderate POAG eyes, with previous successful cataract extraction. Moreover, it provides a standardized protocol that could be replicated in future studies investigating various types of MIGS. This would allow comparison between different techniques in terms of efficacy, safety, and patients\' quality of life.
BACKGROUND: Retrospectively registered at the Registro Brasileiro de Ensaios Clínicos (ReBEC) platform RBR-268ms5y . Registered on July 29, 2023. The study was approved by the Ethics Committee of the University of Campinas, Brazil.
摘要：
背景：微创青光眼手术（MIGS）是一类新型手术，它结合了中等到高的成功率和高的安全性。BentAbinterno针内切开术（BANG）和房角镜检查辅助腔内小梁切开术（GATT）是两种低成本的MIGS手术，可将前房与Schlemm管连通。关于MIGS的大多数现有出版物要么是病例系列研究，要么是回顾性研究，不同的研究方案。本手稿的目的是描述一项随机临床试验（RCT）方案，以比较长期眼内压（IOP）控制和两种手术在原发性开角型青光眼中的安全性。
方法：这是并行的，双臂,包括假晶状体原发性开角型青光眼（POAG）眼的单盲RCT。纳入标准后，手术前将洗掉药物以验证基线IOP.使用密封的信封将患者随机分配至BANG或GATT。随访时间为手术后1、7、15、30、60、90、180、330和360天。在PO330上，将进行新的药物清除。主要结果是手术后的IOP降低。功能和结构参数的补充评估，安全,生活质量将在30、90、180和360天后完成。
结论：我们的研究旨在比较两种低成本MIGS的长期疗效和安全性。大多数已发表的关于这一主题的研究是病例系列或回顾性队列，不同的研究方案，其中包括不同类型和严重程度的青光眼，联合白内障摘除术。我们的研究只包括轻度到中度的POAG眼,与以前成功的白内障摘除。此外，它提供了一个标准化的方案,可以在研究各种类型MIGS的未来研究中复制.这将允许在功效方面比较不同的技术，安全,和患者的生活质量。
背景：在巴西注册中心（ReBEC）平台RBR-268ms5y进行了回顾性注册。2023年7月29日注册。这项研究得到了坎皮纳斯大学伦理委员会的批准，巴西。
方法：这是并行的，双臂,包括假晶状体原发性开角型青光眼（POAG）眼的单盲RCT。纳入标准后，手术前将洗掉药物以验证基线IOP.使用密封的信封将患者随机分配至BANG或GATT。随访时间为手术后1、7、15、30、60、90、180、330和360天。在PO330上，将进行新的药物清除。主要结果是手术后的IOP降低。功能和结构参数的补充评估，安全,生活质量将在30、90、180和360天后完成。
结论：我们的研究旨在比较两种低成本MIGS的长期疗效和安全性。大多数已发表的关于这一主题的研究是病例系列或回顾性队列，不同的研究方案，其中包括不同类型和严重程度的青光眼，联合白内障摘除术。我们的研究只包括轻度到中度的POAG眼,与以前成功的白内障摘除。此外，它提供了一个标准化的方案,可以在研究各种类型MIGS的未来研究中复制.这将允许在功效方面比较不同的技术，安全,和患者的生活质量。
背景：在巴西注册中心（ReBEC）平台RBR-268ms5y进行了回顾性注册。2023年7月29日注册。这项研究得到了坎皮纳斯大学伦理委员会的批准，巴西。
