Baerveldt Plate Area Comparison (BPAC)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 69
- 试验地点
- 8
- 主要终点
- Visual Acuity as assessed by Early Treatment Diabetic Retinopathy Study (EDTRS)
研究概览
简要总结
This research is being done to compare the safety and effectiveness of two sizes of the Baerveldt glaucoma implant.
A Baerveldt glaucoma implant is one of the most common types of glaucoma operations performed. This procedure works by providing a route by which fluid can drain out of the eye to decrease the intraocular pressure. The Baerveldt implant does this by placing a tube into the eye which shunts aqueous fluid to a silicone plate which is attached to the sclera (white portion of the eye). It is this plate that comes in two different sizes (250 square millimeters and 350 square millimeters).
Earlier studies have shown that larger plate sizes produce lower eye pressures but that they may also result in more complications. While both Baerveldt devices are currently in use and have been shown to be safe and effective, it is unclear if one is superior to the other. The purpose of this study is to see if one size of device works better with fewer complications.
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 over 18
- •Intra-Ocular Pressure (IOP) > 18 mm Hg and < 40 mm Hg on medical therapy
- •Previous ocular surgery limited to (cataract, corneal transplant, trabeculectomy, vitrectomy)
- •Consent signed
排除标准
- •Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits
- •Pregnant or nursing
- •Neuro-Linguistic Programming (NLP) vision
- •Iris neovascularization or proliferative retinopathy
- •Epithelial or fibrous downgrowth
- •Chronic or recurrent uveitis
- •Steroid-induced glaucoma
- •Severe posterior blepharitis
- •Previous cyclodestructive procedure
- •Conjunctival scarring from prior ocular trauma or cicatrizing disease (e.g. Stevens Johnson syndrome, ocular pemphigoid) precluding Baerveldt implantation.
- •Functionally significant cataract
- •Need for Baerveldt implant combined with other ocular procedures (ie cataract surgery,penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery
- •Prior glaucoma drainage device (tube) implant
- •Prior retinal surgery with remaining silicone oil
- •Prior scleral buckling procedures
结局指标
主要结局
Visual Acuity as assessed by Early Treatment Diabetic Retinopathy Study (EDTRS)
时间窗: Up to 5 years
Visual acuity is an important outcome variable in the BPAC. Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity testing will be employed at the Qualifying Assessment and at every follow-up visit.The patient starts are the top of the chart and begins to read down the chart. The patient reads down the chart until he or she reaches a row where a minimum of three letters on a line cannot be read. The patient is scored by how many letters could be correctly identified. ETDRS visual acuity is required at the Qualifying Assessment and at the 1 year, 3 year, and 5 year follow-up visits
次要结局
未报告次要终点