Prospective Randomized Study Comparing Ex-PRESS to Trabeculectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Intraocular Pressure
研究概览
简要总结
Prospective randomized study comparing guarded Ex-PRESS to trabeculectomy. Primary outcome: IOP and success (complete success defined as IOP between 5-18 mmHg and 20% reduction from baseline without medication or additional glaucoma surgery and qualified success defined as IOP between 5-18 mmHg and 20% reduction from baseline with or without glaucoma medication but no additional glaucoma surgery). Secondary outcomes: number of glaucoma medications, visual acuity, number of complications, corneal pachymetry and corneal endothelial cell counts.
详细描述
Complications will be evaluated for the intra-operative, early post-operative (up until 1 month) and late post-operative (from 1 month to 1 year) periods. In addition complications will be evaluated as severe (defined as a permanent reduction in vision or complications requiring a surgical intervention) and not severe (complications which resolve with conservative management). As an individual subject may have more than one complication, the number of complications will be compared between the two surgical groups.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 to 85
- •open-angle glaucoma uncontrolled medically
- •intraocular pressure ≥ 18 mmHg
- •trabeculectomy as the planned surgical procedure
排除标准
- •any previous ocular incisional surgery with the exception of previous clear
- •cornea cataract surgery
- •vitreous present in anterior chamber
- •patient unwilling or unable to accept randomization or to give consent or to attend the follow up visits
结局指标
主要结局
Intraocular Pressure
时间窗: 1 year post surgery
Success Rate (IOP Between 5-18 mmHg and 20% Reduction From Baseline) Without Glaucoma Medication
时间窗: 1 year post surgery
次要结局
- Complications(1 year post surgery)
研究者
Yvonne Buys
MD, FRCSC; Professor
University of Toronto