A Multi Center Study Comparing the Ex-PRESSTM Mini Glaucoma Shunt to Trabeculectomy in Subjects With Open Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 16
- 主要终点
- Postoperative Intraocular Pressure
研究概览
简要总结
A prospective randomized trial to compare the safety and efficacy of the Ex-PRESS to trabeculectomy in patients with open angle glaucoma who failed medical or are allergic to medical treatment and for which filtering surgery is indicated. Surgical success was defined as 5 mmHg ≤ intraocular pressure ≤ 18 mmHg, with or without medications, without further glaucoma surgery. Postoperative intraocular pressure, number of medications, complications and success rates were followed for 2 years.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult subject over the age of 18
- •Subject diagnosed with open angle glaucoma (POAG, PXFG or PDSG) or ocular hypertension
- •Subject is a candidate for filtering surgery with intraoperative anti-metabolites
- •IOP > 18 mmHg on maximum tolerated medial therapy based on two measurements taken 1 hour apart at the same visit.
- •Subject willing to attend all follow-up evaluations
- •Subject willing to sign informed consent.
排除标准
- •Subject diagnosed with: PACG, NTG, secondary glaucoma, neovascular glaucoma
- •Subject has history of glaucoma surgery (filtering, glaucoma drainage device, cyclo destructive procedures)
- •Subject has history of penetrating keratoplasty (PKP)
- •Subject underwent large incision extra capsular cataract extraction
- •Subject had cataract phacoemulsification within the last month
- •Subject has a visually significant cataract that is planned for extraction at the time of filtering surgery or within 12 months thereafter
- •Any ocular disease or history in the operated eye other than glaucoma and cataract, such as uveitis, ocular infection, severe dry eye, severe blepharitis , active proliferative retinopathy, ICE syndrome, epithelial or fibrous down growth, aphakia, and ocular pathology that may interfere with accurate IOP measurements
- •Subject has vitreous present in the anterior chamber for which vitrectomy is anticipated
- •IOP of ≤18mmHg
- •Subject participates in any other concurrent ocular investigation.
结局指标
主要结局
Postoperative Intraocular Pressure
时间窗: assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m. 24 months reported
Mean postoperative intraocular pressure
Medications
时间窗: assessed at 1d, 1w, 1m, 3m, 6m, 12m, 18m, 24m; 24 months reported
次要结局
- Efficacy - The Number of Participants With Qualified and Complete Success(24 months)
- Safety - Incidence of Adverse Events(24 months)
研究者
Peter Netland, MD
Vernah Scott Moyston Professor, Chair, Department of Ophthalmology
University of Virginia