Trabeculectomy Versus 2-iStent and Prostaglandin Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- IOP >= 20% reduction from untreated baseline
研究概览
简要总结
Investigators hypothesize that the synergistic action of iStent in increasing aqueous outflow through the trabecular meshwork and use of prostaglandin analog such as travoprost or latanoprost to increase uveoscleral outflow will achieve good Intra-ocular Pressure (IOP) control with minimal complications in Primary Open Angle Glaucoma (POAG) patients with suboptimal IOP on 2 or more medications compared to mitomycin C (MMC) augmented trabeculectomy.
详细描述
This will be a prospective randomized controlled study.
20 phakic or pseudophakic open angle glaucoma patients with an IOP in the range of 18-30 mmHg on 2 or more topical glaucoma medications will be randomly selected to undergo either (1) mitomycin-augmented trabeculectomy or (2) placement of 2 iStent devices and initiation of a daily prostaglandin analog. This study is looking at the combined effects of the 2 iStents and a prostaglandin analog as a method to achieve low IOP. At 3 months (+/- 2 weeks) postoperatively, the iStent patients will be left only on the prostaglandin analog with a washout performed for any other hypotensive medication used. Patients who had a trabeculectomy will be have a terminal washout of all IOP-lowering medications at 3 months (+/- 2 weeks) post-surgery. The IOP will then be measured for both groups at 4 months (+/- 3 weeks) postoperatively.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who have mental capacity to give consent
- •Age >= 21 years
- •Pseudophakic or phakic without visually significant cataract
- •Open angle glaucoma
- •IOP in the range of 18-30 mmHg with 2 or more topical medications
- •Cup-disc ratio =< 0.9
- •Best corrected visual acuity of 20/100 or better
排除标准
- •Inability to give consent
- •Inability to tolerate or presence of allergy to prostaglandin analogs
- •Patient preference for non-surgical treatment or preference for either of the recommended surgical modalities in the study
- •Age < 21 years
- •Visually significant cataract that would benefit from cataract surgery, as determined by the treating surgeon in consultation with the patient
- •Secondary glaucoma or angle closure glaucoma
- •Prior glaucoma incisional surgery (trabeculectomy, tube surgery, other Microinvasive Glaucoma Surgery (MIGS) surgeries, deep sclerectomy)
- •Prior laser trabeculoplasty < 90 days prior to screening or absolute failure of prior laser trabeculoplasty.
研究组 & 干预措施
2 iStent with travoprost or latanoprost
2 iStents will be injected into the trabecular meshwork and patients will be administered topical latanoprost or travoprost following surgery
干预措施: iStent and travoprost or latanoprost (Device)
trabeculectomy
Standard trabeculectomy
干预措施: Trabeculectomy (Procedure)
结局指标
主要结局
IOP >= 20% reduction from untreated baseline
时间窗: Post surgery month 4
IOP
IOP <= 18 mmHg
时间窗: Post surgery month 4
IOP
IOP <= 15 mmHg
时间窗: Post surgery month 4
IOP
次要结局
未报告次要终点