Retrospective Review of Xen Gel Stent Implantation With Open vs. Closed Conjunctiva Approach
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- re-intervention rate
研究概览
简要总结
To measure surgical success of open vs closed conjunctiva with Xen implantation.
详细描述
This retrospective, single-arm multicenter study included >100 eyes (>100 patients) with glaucoma refractory to medical therapy. All surgeries were performed by two groups of surgeons at Johns Hopkins University and the sub-investigator group at New York University. Group 1: Xen with open conjunctiva for positioning and application of mitomycin. The Xen was placed through the sclera either ab-interno or ab-externa. Group 2 had Xen placed ab-interno or ab-externa (trans conjunctival), but the conjunctiva was not opened for positioning or application of mitomycin-C.
Success rates will be determined based on need for re-intervention and intraocular pressure control.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Require surgery for uncontrolled glaucoma
排除标准
- 未提供
结局指标
主要结局
re-intervention rate
时间窗: 3 months
This will be assessed as the proportion of patients that will need fibrosis relief by stent re-implantation
次要结局
- Change in intraocular pressure(1 day, 1 week, 1 month and 3 months)