Comparison of Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. A Randomised, Prospective Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- IOP
研究概览
简要总结
It is a comparative study of Safety and Efficacy of Canaloplasty and Non-penetrating Deep Sclerectomy Combined With Phacoemulsification to Treat Glaucoma and Cataract. It is a Randomised, Prospective Study.
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
- Single (Investigator)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •co-existing glaucoma and cataract
- •glaucoma types ( open angle glaucoma,pseudoexfoliation syndrome, pigmentary glaucoma)
- •eye with characteristic glaucoma changes (biomicroscopic,visual field) with IOP >16mmHg on medication or without, or IOP<16mmHg on 2 or more medications.
- •uncontrolled IOP
- •patients not tolerating antiglaucoma medications,
- •patients with poor compliance
- •progression in visual field
排除标准
- •previous surgical glaucoma procedure
- •previous cataract surgery
- •visual function under 0,004
- •closed angle glaucoma
- •poorly controlled diabetes mellitus
- •advanced AMD
- •active inflammatory disease
- •pregnancy
- •mental disease or emotional instability, that could
结局指标
主要结局
IOP
时间窗: Change from Baseline at 24months
by Goldman tonometry Primary efficacy outcome-proportion of the population that achieves an IOP of \>5 and ≤ 21 mmHg, irrespective of glaucoma medication use. Complete success is defined as achieving the target IOP without use of medications. A qualified success is defined as achieving the target IOP with either no change in medications or a reduction in medication as compared to that used preoperatively.
number of antiglaucoma medications
时间窗: Change from Baseline at 24months
visual acuity
时间窗: Change from Baseline at 24months
ETDRS chart
intraoperative complications
时间窗: surgery day
Rates for surgical complications and adverse events
次要结局
- Secondary procedures(within 24 months)
- Early and late complications(within 24 months)
研究者
Marek Rekas
MD, PhD Associate Professor of Ophthalmology
Military Institute od Medicine National Research Institute