Comparing the Baerveldt and Paul Glaucoma Drainage Devices and Their Effects on the Corneal Endothelium
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Change of endothelial cell density (ECD).
研究概览
简要总结
Rationale: The Baerveldt glaucoma drainage device (GDD) successfully reduces intraocular pressure but also involves a risk of corneal endothelial deterioration. Supposedly, the tip of a GDD tube with a thinner diameter, such as the Paul implant, will remain at a larger distance from the cornea and, thereby, cause less damage.
Objective: To determine whether the Paul tube induces less damage to the corneal endothelium than the Baerveldt GDD.
Study design: Randomized clinical trial. Study population: Phakic patients scheduled for surgical GDD implantation. Intervention: Either a Baerveldt or a Paul GDD implant. Main study parameters/endpoints: Endothelial cell density and tube position at 24 months.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The Paul GDD may have a less harmful effect on corneal endothelium. Otherwise, both GDDs will probably have a similar risk/benefit profile. The risks of study-related assessments are negligible, burden is low, extra time is about 5 x 1.5 h (total 7.5 h) in two years.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years.
- •Informed consent.
- •Caucasian ethnicity (to facilitate comparison of results with those of earlier work). Ethnicity will be based on self-reported origin of subject and/or parents.
- •Primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma.
排除标准
- •History of intraocular surgery (e.g. vitrectomy, cataract surgery, cyclodestructive procedures etc).
- •History of ocular comorbidity (e.g. active uveitis, proliferative diabetic retinopathy).
- •Pseudophakia.
- •Functionally monocular patients.
- •Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, keratoplasty, or retinal surgery) or an anticipated need for additional ocular surgery.
- •Narrow anterior chamber angle.
- •Best corrected visual acuity less than 0.
- •Severe blepharitis.
结局指标
主要结局
Change of endothelial cell density (ECD).
时间窗: Baseline and 2 years
ECD will be assessed at the center of the cornea and close to the tube.
次要结局
- Intraocular pressure.(Baseline, 1, 3, 6, 12, 24 months.)
- Orthoptic assessment.(Baseline, 3, 6, 12, 24 months.)
- Endothelial cell density (ECD).(Baseline, 3, 6, 12, 24 months.)