Efficacy and Safety of Posterior Chamber Glaucoma Drainage Device in Refractory Pseudophakic Glaucoma Patients
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- IOP
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of Ahmed glaucoma valve (AGV) implantation in the posterior chamber (ciliary sulcus) compared with the traditional anterior chamber placement in patients with refractory pseudophakic glaucoma, who are adults (>18 years), have undergone cataract surgery with intraocular lens implantation, and are unresponsive to maximal medical therapy.
The main questions it aims to answer are:
Does posterior chamber AGV implantation effectively lower intraocular pressure (IOP) compared to anterior chamber implantation? Does posterior chamber AGV implantation result in less corneal endothelial cell loss and lower rates of postoperative complications compared to anterior chamber implantation?
Researchers will compare the two groups:
Intervention group: AGV implantation in the posterior chamber (ciliary sulcus) Control group: AGV implantation in the anterior chamber
Participants will:
Undergo a baseline evaluation, including ocular examination, IOP measurement, corneal endothelial cell density (ECD) and variability, visual field testing, and optic nerve imaging.
Be randomized into two groups based on a computer-generated randomization method.
Receive either posterior chamber or anterior chamber AGV implantation. Be followed postoperatively at specified intervals (1 day, 1 week, 1 month, 3 months, 6 months, 12 months) for IOP, use of glaucoma medications, visual acuity (Snellen, logMAR), corneal ECD, and endothelial cell variability (CV).
Undergo regular assessments for postoperative complications such as hypotony, choroidal detachment, hyphema, infection, and device-related issues.
Provide informed consent after explanation of potential risks and benefits of the procedure.
This study will use a prospective, randomized controlled clinical trial design, enrolling at least 29 eyes in each group, conducted at the Glaucoma Department of Ho Chi Minh City Eye Hospital from March 2024 to March 2027
详细描述
- Background and Rationale Refractory glaucoma in pseudophakic eyes presents a significant clinical challenge due to its resistance to maximal medical therapy and often poor response to conventional filtering surgeries. In these patients, the implantation of a glaucoma drainage device (GDD), such as the Ahmed glaucoma valve (AGV), has emerged as a viable therapeutic strategy. Traditionally, GDDs are inserted with the tube placed into the anterior chamber (AC). However, anterior chamber placement may be associated with long-term complications, such as corneal endothelial decompensation, synechiae, iris chafing, and chronic inflammation.
The posterior chamber, specifically the ciliary sulcus, offers an alternative site for tube placement in pseudophakic eyes where the natural lens has already been removed. The sulcus location provides a deeper site for the tube, reducing the risk of contact with the corneal endothelium. Preliminary evidence and retrospective series suggest that sulcus placement can achieve comparable IOP-lowering efficacy while minimizing endothelial cell loss. However, to date, there is a lack of high-quality randomized controlled trials that rigorously compare the safety and efficacy outcomes of anterior vs posterior chamber tube placement in pseudophakic patients.
This study is designed to address this gap in the literature by evaluating Ahmed glaucoma valve implantation with tube placement in the posterior chamber (ciliary sulcus) compared with standard anterior chamber placement in patients with refractory pseudophakic glaucoma. 2. Objectives Primary Objective To evaluate and compare the intraocular pressure (IOP) reduction at 12 months following AGV implantation in the posterior chamber (ciliary sulcus) versus anterior chamber placement in eyes with refractory pseudophakic glaucoma.
Secondary Objectives To assess the difference in corneal endothelial cell loss between the two groups.
To compare the number of glaucoma medications required postoperatively. To evaluate the incidence of postoperative complications in both surgical groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years.
- •Diagnosis of refractory glaucoma (uncontrolled intraocular pressure despite maximal tolerated antiglaucoma medications).
- •History of cataract extraction with intraocular lens implantation (pseudophakia).
- •Agreement to participate in the study and ability to comply with outpatient follow-up requirements
排除标准
- •Presence of corneal opacities that preclude accurate endothelial assessment.
- •Co-existing corneal diseases that could affect endothelial cell status (e.g., Fuchs' dystrophy, corneal edema).
- •Single-eye (monocular) status.
- •Systemic medical conditions affecting coagulation or carrying increased surgical risk (e.g., uncontrolled diabetes, bleeding disorders)
研究组 & 干预措施
Anterior chamber
Control group
干预措施: GDD in aterior chamber (Device)
Study group
AGV in Posterior chamber
干预措施: GDD in posterior chamber (Device)
结局指标
主要结局
IOP
时间窗: IOP change at 12 months postoperatively
ECD
时间窗: Corneal endothelial cell density (ECD) change from baseline to 12 months
次要结局
未报告次要终点
研究者
Quyen Vo Mai Huynh
Vice Head of General Planning Department
Eye Hospital of Ho Chi Minh City