The Long-term Safety and Efficacy of a Modified Suprachoroidal Silicone Tube (SST) Shunt in Patients with Primary Open-angle Glaucoma (POAG) and Pseudo-exfoliative Glaucoma (PXG) Over an Extended Follow-up Period
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Endothelial Cell Loss
研究概览
简要总结
The goal of this observational study is to evaluate the long-term safety and efficacy of a modified suprachoroidal silicone tube (SST) shunt in treating patients with primary open-angle glaucoma (POAG) and pseudo-exfoliative glaucoma (PXG).
The main questions it aims to answer are:
Does the SST shunt maintain intraocular pressure (IOP) reduction over an extended follow-up period? What is the effect of the SST shunt on endothelial cell count (ECC) and overall corneal health?
Participants will:
Undergo intraocular pressure (IOP) measurements Have their endothelial cell count (ECC) evaluated Complete assessments of best corrected visual acuity (BCVA) Be assessed for C/D ratio Be monitored for adverse events or shunt-related complications over time
详细描述
This observational study serves as an extension to a prior retrospective cross-sectional trial that initially investigated the clinical outcomes of suprachoroidal silicone tube (SST) shunt implantation in patients diagnosed with primary open-angle glaucoma (POAG) and pseudoexfoliative glaucoma (PXG). In the initial study, participants underwent the SST shunt procedure and were followed for an average period of 19 months post-surgery. This initial study focused on assessing intraocular pressure (IOP) reduction and the initial safety profile of the SST device. However, as the device's long-term impact on ocular health, particularly the corneal endothelium, was not fully understood, this follow-up observational study was designed and implemented approximately 1 year after the last FU data collection was completed.
The SST shunt device is a relatively novel intervention positioned between minimally invasive glaucoma surgeries (MIGS) and traditional tube shunt surgeries. By facilitating aqueous humor drainage from the anterior chamber to the suprachoroidal space, the SST shunt provides a unique pathway for IOP reduction. Given the risks associated with corneal endothelial health in glaucoma patients, especially following invasive procedures, understanding the long-term impact of the SST shunt on endothelial cell counts (ECC) is essential.
Study Objectives:
The primary objective of this observational study is to evaluate the long-term safety and efficacy of the SST shunt in reducing IOP and preserving endothelial cell health. This involves:
Tracking changes in ECC attributable solely to the SST shunt, as the study design excluded additional interventions to isolate the device's effect.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously were treated with Suprachoroidal silicone tube shunt
- •Willing and able to participate in this cross sectional observational follow up
- •Participant capable of giving informed consent
排除标准
- •Condition that could impact the ability of the participant to attend a follow-up visit as per the discretion of the investigator
结局指标
主要结局
Endothelial Cell Loss
时间窗: From enrollment to the end of long term observational FU (average duration is 31 months with 8 months std. dev)
IOP Control: Success was defined as ≥20% reduction in IOP, with "complete success" for IOP control without medications, "qualified success" with medications, and "failure" for <20% IOP reduction or IOP >21 mmHg.
时间窗: From enrollment to the end of long term observational FU (average duration is 31 months with 8 months std. dev)
次要结局
- Hypotony, defined as intraocular pressure (IOP) < 5 mmHg, categorized as either transient or permanent.(From enrollment to the end of long term observational FU (average duration is 31 months with 8 months std. dev))
- Device migration or extrusion, monitored to assess mechanical stability of the implant.(From enrollment to the end of long term observational FU (average duration is 31 months with 8 months std. dev))
- Adverse Events/Severe Adverse Events: Device-related or non-device-related(From enrollment to the end of long term observational FU (average duration is 31 months with 8 months std. dev))