The Effect of Scheduled Ripcord Removal on the Outcomes of Baerveldt 350 Implants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 2
- 主要终点
- Incidence of post-operative complications
研究概览
简要总结
The purpose of this study is to compare the post-operative complication rates and surgical outcomes in patients with a Baerveldt 350 implant following scheduled rip-cord removal in clinic at post-operative week 3 versus spontaneous tube opening. Patients age 18 or greater with uncontrolled glaucoma and scheduled to undergo their first superotemporal Baerveldt 350 implant will be recruited and randomized at the time of enrollment to either scheduled ripcord removal at post-operative week 3 or no ripcord removal. Incidence of complications will be documented and compared between the 2 groups. The final intraocular pressure control between the 2 groups will also be compared in a secondary outcome analysis. This study will help to establish post-operative management guidelines to minimize complications and improve intraocular pressure lowering success following Baerveldt 350 implantation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
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
- •Men or women aged 18 years and older at screening. There is no upper age limit.
- •Inadequately controlled glaucoma refractory to maximum therapy
- •Suitable candidate for Baerveldt-350 implant in the superotemporal quadrant in the study eye, which the physician deems as medically necessary.
- •Capable and willing to provide consent
排除标准
- •Unable or unwilling to provide consent
- •Any previous ocular surgery other than cataract extraction or trabeculectomy
- •Any previous ocular surgeries in the study eye preventing placement of the Baerveldt-350 implant in the superotemporal quadrant
- •Any abnormality other than glaucoma in the study eye that could affect tonometry.
- •Presence or history of any abnormality or disorder that could interfere with the study procedure or prevent the successful completion of the study.
- •Monocularity (where best corrected visual acuity in the non-operative eye is worse than 20/200)
- •Any significant unstable cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hematologic, neurologic, or psychiatric disease.
- •Known pregnant or breastfeeding women
研究组 & 干预措施
Observation
Patients randomized to observation will be observed during the post-operative period for spontaneous Baerveldt-350 tube opening. The ripcord will not be removed unless deemed medically necessary by the study physician.
Ripcord removal
Patients randomized to intervention will have their ripcords removed in clinic at post-operative week 3.
干预措施: Ripcord removal (Procedure)
结局指标
主要结局
Incidence of post-operative complications
时间窗: Up to 6 months
Incidence of complications (including but not limited to shallowing of the anterior chamber, hypotony, choroidal effusion and choroidal hemorrhage) will be documented and compared between the 2 groups.
次要结局
- Incidence of successful intraocular pressure control(Post-operative month 6)