Re-Trabeculectomy Versus Ahmed Glaucoma Valve Implantation in Secondary Surgical Management of Patients With Refractory Primary Open Angle Glaucoma: a Three-year Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- Change in target intraocular pressure (IOP)
研究概览
简要总结
The purpose of this study is to compare three-year outcomes of re-trabeculectomy with those of Ahmed glaucoma valve implantation in secondary surgical management of patients with primary open angle glaucoma (POAG) and a history of previous failed trabeculectomy.
详细描述
Currently, lowering intraocular pressure (IOP) is the only treatment modality to prevent or slow progression of glaucomatous optic nerve damage. Incisional procedures are indicated when medical therapy and/or laser procedures cannot adequately reduce IOP. Trabeculectomy is the most common glaucoma incisional procedure globally. On the other hand, glaucoma drainage devices that have been historically reserved for cases of glaucoma deemed at high risk of failure have increasingly gained popularity particularly in eyes with previous history of glaucoma surgery.
There is still no agreement on the appropriate surgical procedure in those with prior glaucoma surgery. The five-year tube versus trabeculectomy (TVT) study, which evaluated the efficacy and safety of Baerveldt glaucoma implant versus trabeculectomy, showed that both surgical procedures had similar IOP reduction and use of anti-glaucoma medication; tube shunt surgery had a higher success rate than trabeculectomy with mitomycin C (MMC); the trabeculectomy/MMC had higher incidence of early postoperative complications compared to tube shunt surgery; and rates of late postoperative complications, reoperation for complications, and cataract extraction were comparable in both treatment groups.
In this study, the investigators compared three-year outcomes of re-trabeculectomy with those of Ahmed glaucoma valve implantation in secondary surgical management of patients with primary open angle glaucoma and a previous history of failed trabeculectomy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Uncontrolled glaucoma defined as (1) IOP not achieving previously assigned target pressure despite prior trabeculectomy and use of maximally tolerated anti-glaucoma medication; and (2) recent progression of the disease based on glaucomatous changes in optic disc appearance and/or worsening of the visual field exam.
- •In the case of two eligible eyes, only the first eye being operated on was enrolled
排除标准
- •Younger than 40 years old
- •Visual acuity of no light perception
- •Lens opacity
- •Elevated IOP associated with silicone oil
- •Prior ocular surgeries other than one trabeculectomy with MMC
- •Previous cyclodestructive treatment
- •Increased risk of endophthalmitis
- •Posterior segment disorders
- •Pre-existing ocular comorbidities (e.g. pterygium,phacodonesis,corneal opacity, or corneal endothelial dystrophies)
结局指标
主要结局
Change in target intraocular pressure (IOP)
时间窗: day 1, week 1, months 1,3,6,9,12,18,24,30,36
All patients had a target IOP that had been assigned for them by the same surgeon prior to their initial failed trabeculectomy/MMC. The routine practice of the surgeon has been to set target IOP based on the Best Practice Treatment Algorithm for POAG. This was based on at least 25% reduction in baseline IOP. Target IOP needs constant reevaluation during the follow-up based on disease progression. In our study, success and failure were considered to be assessed based on change in the target pressure.
次要结局
- Visual Acuity(day 1, week 1, months 1,3,6,9,12,18,24,30,36)
- Mean deviation of visual field exam(Months 6,12,18,24,30,36)
- Number of anit-glaucoma medications(day 1, week 1, months 1,3,6,9,12,18,24,30,36)
- Surgical Success(day 1, week 1, months 1,3,6,9,12,18,24,30,36)
研究者
Nariman Nassiri
Prinicpal Investigator
Vanak Eye Surgery Center