Evaluating the Efficacy of Fenestrations in Tube Shunt Implants During the Early Postoperative Period
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Number of participants with successful control of intraocular pressure
研究概览
简要总结
This study evaluates two different methods of controlling intraocular pressure in nonvalved aqueous tube shunts immediately after implantation; needle fenestrations or a suture wick.
详细描述
This is a prospective, randomized control study of glaucomatous eye undergoing tube shunt implantation using a nonvalved implant for poorly controlled glaucoma of any type. Eyes scheduled to receive a nonvalved tube shunt implant will be randomized to receive either needle fenestration(s) or a suture wick using a single 10-0 vicryl anterior to the ligature. The operative quadrant will be imaged using anterior-segment optical coherence tomography at pre- and post-operative visits.
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
- •18 years of age or older
- •Eyes that have poorly controlled glaucoma requiring a tube shunt implantation
- •Willingness to participate in the study and sign informed consent
排除标准
- •Concurrent surgery except phaco/intraocular lens
- •Any abnormality preventing reliable applanation tonometry
- •Eyes with exposure limitation (tight lids, deep orbits) that would make performing the anterior segment optical coherence tomography difficult
结局指标
主要结局
Number of participants with successful control of intraocular pressure
时间窗: 3 weeks
Successful control of intraocular pressure is defined as IOP between 5 and 21 mmHg without medications within 3 weeks postop.
次要结局
- Duration of effect on intraocular pressure control(12 weeks)
- Peri-fenestration bleb volume prior to tube opening(3 weeks)
- Peri-fenestration bleb volume after the tube has opened(12 weeks)
- Intraocular pressure after the tube has opened(12 weeks)
研究者
Robert Feldman
Department Chair
The University of Texas Health Science Center, Houston