NCT04468633已完成不适用
The Baerveldt Versus ClearPath Comparison Study
Duke University2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2020年12月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Intraocular Pressure (IOP)
研究概览
简要总结
This is a randomized prospective study of post-operative surgical outcomes and complication rates in patients with a Baerveldt 350 implant vs the Ahmed ClearPath implant. Each subject will be randomized to the Baerveldt group or ClearPath group at the time of consent for the study.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women with age at screening ≥ 18 years and ≤ 90 years
- •Inadequately controlled glaucoma
- •Valve-less aqueous shunt as the planned surgical procedure
- •Patients with primary glaucomas or pseudoexfoliation, pigmentary and traumatic glaucoma with a previous failed trabeculectomy or other intraocular surgery included.
- •Primary tubes included
- •Investigators to recruit consecutively all eligible patients from their clinics.
- •Superotemporal or inferonasal placement of the tube
- •Capable and willing to provide consent
排除标准
- •Unable/unwilling to provide informed consent
- •Unavailable for regular follow up
- •Previous cyclodestructive procedure
- •Prior scleral buckling procedure or other external impediment to supratemporal drainage device implantation
- •Presence of silicone oil
- •Vitreous in the anterior chamber sufficient to require a vitrectomy
- •Uveitic glaucoma
- •Neovascular glaucoma
- •Nanophthalmos
- •Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure
- •Procedure combined with other surgery
- •Any abnormality other than glaucoma in the study eye that could affect tonometry.
结局指标
主要结局
Intraocular Pressure (IOP)
时间窗: Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1
Number of Participants Who Experienced a Complication
时间窗: Up to Year 1
次要结局
- Best Corrected Visual Acuity (BCVA)(Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1)
- Number of Individual Eyedrop Medications That the Patient is on (Prescribed and Actually Taking)(Baseline, Day 1, Week 1, Week 4, Week 6, Month 3, Month 6, and Year 1)
- Change in Humphrey Visual Field (HVF)(Baseline and Year 1)
- Change in Thickness of the Cornea as Measured by Pachymetry(Baseline and Year 1)
- Change in Retinal Nerve Fiber Layer (RNFL)(Baseline and Year 1)
研究者
研究点 (2)
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