Trabecular Microbypass IStent in Patients with Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Intraocular pressure (IOP) in mmHg or percentage changes
研究概览
简要总结
The goal of this clinical trial is to assess the safety and efficacy of phacoemulsification combined with one trabecular micro-bypass stent implantation (phaco-iStent) versus phacoemulsification alone in a Taiwanese population, as well as to investigate any differences in outcomes between patients with primary open angle glaucoma (POAG) and those with normal tension glaucoma (NTG). The main question it aims to answer is:
• How much do intraocular pressure (IOP) and the number of antiglaucoma medications change after iStent insertion, with subgroup analyses for POAG and NTG? Researchers will compare phacoemulsification combined with one trabecular micro-bypass stent implantation (phaco-iStent) versus phacoemulsification alone to see if IOP and the number of antiglaucoma medications decrease.
Participants will receive their regular phacoemulsification and decided whether to receive iStent by themselves.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients evaluated by a clinician who require cataract surgery or cataract surgery combined with iStent implantation due to concomitant glaucoma and cataracts.
排除标准
- •Eyes that have previously undergone vitrectomy or retinal surgery.
- •Patients with ocular surface inflammation (e.g., corneal ulcers, orbital cellulitis, etc.).
- •Patients with hypotony (intraocular pressure <5 mmHg).
- •Patients with a history of globe rupture.
研究组 & 干预措施
phacoemulsification combined with one trabecular micro-bypass stent implantation (phaco-iStent)
In glaucoma patient who needed to receive cataract surgery, a standard phacoemulsification procedure was performed, along with the implantation of a foldable posterior chamber intraocular lens (PCIOL). Then, in this group, we further inserted a preloaded micro-bypass stent (model GTS100L) through the temporal corneal incision into the nasal Schlemm's canal and checked the position. Adequate intraocular pressure (IOP) was assessed by palpation at the end of the surgery.
干预措施: first generation iStent (Glaukos, San Clemente, CA, USA) insertion (Device)
phacoemulsification combined with one trabecular micro-bypass stent implantation (phaco-iStent)
In glaucoma patient who needed to receive cataract surgery, a standard phacoemulsification procedure was performed, along with the implantation of a foldable posterior chamber intraocular lens (PCIOL). Then, in this group, we further inserted a preloaded micro-bypass stent (model GTS100L) through the temporal corneal incision into the nasal Schlemm's canal and checked the position. Adequate intraocular pressure (IOP) was assessed by palpation at the end of the surgery.
干预措施: phacoemulsification (Device)
phacoemulsification alone group
In glaucoma patient who needed to receive cataract surgery, a standard phacoemulsification procedure was performed, along with the implantation of a foldable posterior chamber intraocular lens (PCIOL).
干预措施: phacoemulsification (Device)
结局指标
主要结局
Intraocular pressure (IOP) in mmHg or percentage changes
时间窗: From enrollment to the end of treatment at 18 months
changes in IOP after the intervention
glaucoma medication changes in number
时间窗: From enrollment to the end of treatment at 18 months
glaucoma medication changes in number after the intervention
Visual acuity changes in LogMAR scale
时间窗: From enrollment to the end of treatment at 18 months
Visual acuity changes in LogMAR scale after the intervention in both group
次要结局
- Complete success and qualified success(From enrollment to the end of treatment at 18 months)
研究者
Yu-Ting Tsao
Clinical Doctor
Chang Gung Memorial Hospital