Comparison of Goniotomy Device Outcomes in Combined Phacoemulsification-goniotomy Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Intraocular pressure
研究概览
简要总结
The goal of this study is to determine of one of three different devices to perform goniotomy to treat glaucoma at the time of cataract surgery is more or less effective than the others. The primary outcomes are to compare intraocular pressure control and glaucoma medication use up to 6 months after surgery. Participants will under combined cataract surgery and goniotomy. They will have post-operative follow up visits at 1 day, 1 week, 1 month, 3 months, and 6 month
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
- •Adults ≥ 18 years old
- •Diagnosed with primary or secondary open-angle glaucoma (e.g., POAG, pigmentary, pseudoexfoliative)
- •Scheduled for phacoemulsification with planned goniotomy
- •Able to provide informed consent
排除标准
- •Angle-closure glaucoma
- •Prior glaucoma surgery in the study eye
- •Planned stand-alone goniotomy
- •Inability to comply with follow-up schedule
研究组 & 干预措施
SION
Goniotomy performed with SION
干预措施: Goniotomy (Procedure)
BANG
Goniotomy performed with bent needle
干预措施: Goniotomy (Procedure)
Tanito
Goniotomy performed with Tanito hook
干预措施: Goniotomy (Procedure)
结局指标
主要结局
Intraocular pressure
时间窗: up to 6 months
Eye pressure as measured by Goldmann applanation tonometry in mmHg
Medications
时间窗: up to 6 months
number of medications to control intraocular pressure
Visual Acuity
时间窗: up to 6 months
Measure of visual at each visit on Snellen acuity chart
次要结局
未报告次要终点
研究者
David Crandall
Principal Investigator
Henry Ford Health System