The Ahmed Versus Baerveldt (AVB) Study: Prospective, Multicenter Trial Comparing the Ahmed-FP7 Valve With the Baerveldt-350 Implant in Treating Refractory Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 238
- 试验地点
- 11
- 主要终点
- Number of Participants With Surgical Failure (Composite Measure)
研究概览
简要总结
The purpose of this study is to compare the safety and efficacy of the Ahmed valve and the Baerveldt implant in treating refractory glaucoma. Eligible patients will be recruited from multiple study centers and randomized to a glaucoma drainage device for implantation. They will be followed long-term based upon outcome measures including intraocular pressure, glaucoma medication use, visual acuity, complications of the surgery and further treatments required.
详细描述
Introduction:
The use of a glaucoma drainage device (GDD) is indicated in cases of refractory glaucoma not responsive to conventional medication, laser and surgical therapy. Most of these patients are at high risk for surgical failure, with serious concomitant ocular and systemic diseases. GDD's are increasingly being used to obtain low target intraocular pressures (IOP) in patients who have failed antimetabolite trabeculectomy or have active neovascular glaucoma.
Since Molteno's original design, several drainage devices have become commercially available for implantation. Currently, the two most commonly used devices are the Ahmed Glaucoma Valve (AGV) (New World Medical, Inc., Rancho Cucamonga, CA), and the Baerveldt Glaucoma Device (BGD) (Advanced Medical Optics, Santa Ana, CA). The AGV, with a venture-based flow-restrictive valve is helpful in minimizing postoperative hypotony and complications associated with hypotony, including flat anterior chamber, choroidal effusions, and suprachoroidal hemorrhage. However, there appears to be a high rate of encapsulation and hypertension associated with this device, and increased requirement of postoperative glaucoma medication use. The BGD, a non-valved device, requires early ligature of flow by the use of a suture restriction to allow adequate time for bleb formation. Although this can result in an initial post-operative hypertension phase, it results in less encapsulation and theoretically fewer postoperative glaucoma medications and better IOP control. However, the lack of a flow-restrictor and the large filtering surface area may result in a greater risk for hypotony related complications.
Although several studies comparing the AGV and BGD have been reported, they have all been retrospective, nonrandomized, small scale, and compare different patient populations. The results have been inconclusive and conflicting in evaluating the relative efficacy and characteristics of these two devices, and further research needs to be done in order to answer these questions.
Objective:
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
- •Age greater than or equal to
- •Inadequately controlled glaucoma determined as intraocular pressure (IOP) greater than target, which has not responded to conventional medical and surgical therapy.
- •Patients with significant conjunctival scarring or high-risk disease (active neovascular glaucoma) precluding antimetabolite trabeculectomy will be included in the study.
- •Provide written informed consent to participate in the study.
排除标准
- •Age less than
- •Patient will undergo an additional procedure at the time of glaucoma drainage device implantation (i.e. lensectomy, penetrating keratoplasty)
- •No light perception vision.
- •Patient has already been enrolled in the study in the contralateral eye.
- •Patient is unwilling or unable to provide informed consent to participate in the study, or adhere to the study requirements including implant randomization and required follow-up visits.
研究组 & 干预措施
Ahmed FP7 Valve
Ahmed valve glaucoma drainage device implant for treatment of refractory glaucoma.
干预措施: Ahmed FP7 Valve (Device)
Baerveldt-350 Tube
Baerveldt tube glaucoma drainage device implant for treatment of refractory glaucoma.
干预措施: Baerveldt-350 Tube (Device)
结局指标
主要结局
Number of Participants With Surgical Failure (Composite Measure)
时间窗: 5 years
1. IOP out of target range (5-18 mmHg inclusive) or \<20% reduction from baseline for 2 consecutive visits after 3 months. 2. De novo glaucoma surgery required (e.g., cyclodestructive procedure, additional tube shunt). 3. Removal of the implant. 4. Severe vision loss related to the surgery (endophthalmitis, suprachoroidal hemorrhage with vision loss, enucleation, evisceration, or phthisis bulbi) or progression to no light perception for any reason.
次要结局
- Anti-glaucoma Medications(5 years)
- LogMAR Snellen Visual Acuity(5 years)
- Intraocular Pressure (IOP)(5 years)
- Number of Participants With Complications During or After Surgery(5 years)
- Number of Participants With Interventions After Surgery(5 years)
研究者
Panos G. Christakis
Study Director
Credit Valley EyeCare