Efficacy and Safety of I-stent By-pass Implantation in Eyes With Open Angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 2
- 主要终点
- IntraOcular Pressure measurement (IOP)
研究概览
简要总结
Purpose of this study is to exam the hypotensive effectiveness of I-stent implantation depended on number of antiglaucoma eye drops at baseline.
详细描述
The scientific aim of the project is to estimate the average reduction of intraocular pressure (IOP) in relation to the initial number of antiglaucoma drops at the end of 12 months observation period. The subject must suffer from glaucoma and cataract at the same time, and qualify for a cataract surgery. The group will be composed of 40 patients of the Ophthalmology Clinic of the Medical University of Białystok qualified for planned cataract removal surgery. They will be surgically implanted an I-stent by-pass during phacoemulsification.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 是
入选标准
- •co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale (Lens Opacity Classification System III)
- •patients with primary open-angle glaucoma (POAG), pseudoexfoliative glaucoma (PGX) and normal tension glaucoma (NTG), with topical hypotensive treatment
- •written consent to involvement and participation in the study for a period of at least 12 months was obtained from all patients after they had first been informed of the nature of the procedure and other surgical alternatives
排除标准
- •no consent to participation in the study
- •prior surgical and laser procedures in the area of the eye
- •narrow- or closed-angle glaucoma
- •post-inflammatory or post-traumatic secondary glaucoma
- •chronic illness of the cornea or optic nerve
- •advanced macular degeneration
- •active inflammatory process
- •pregnancy
- •systemic steroid therapy
结局指标
主要结局
IntraOcular Pressure measurement (IOP)
时间窗: baseline, 12 months
change in the level of intraocular pressure measured with Goldmann applanation tonometer
Best Corrected Visual Acuity measurement (BCVA)
时间窗: baseline, 12 months
change in best corrected visual acuity measured with Snellen charts
次要结局
- number of antiglaucoma medicines(baseline, 12 months)