Visual Field Progression and RNFL Change After PreserFlo MicroShunt Implantation - a Prospective Cohort Study at the Ophthalmology Department Klinikum Klagenfurt
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Visual field progression (mean deviation, MD) 1 month postoperative, 3 months postoperative, 6 months and 12 months postoperative after PreserFlo MicroShunt Implantation.
研究概览
简要总结
The trabeculectomy is the gold standard in glaucoma surgery, nevertheless often postoperative interventions have to be done. (1),(2) The PreserFlo MicroShunt (Santen, Osaka, Japan) implantation occurs without critical steps of trabeculectomy. (3) According to a study a 20% eye pressure reduction was achieved in 53.9% of patients one year after PreserFlo MicroShunt implantation and the risk of postoperative hypotony was clearly minimized. (4) It has been shown that after trabeculectomy there is a stable development of visual fields in the first 3 months after surgery and then, despite adequate intraocular pressure reduction, visual fields deteriorate. (5) At the Klinikum Klagenfurt structural and functional changes after PreserFlo MicroShunt Implantation shall be evaluated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients with insufficient eye pressure control despite IOP (intraocular pressure)-lowering therapy
- •Diagnosis of POAG (primary open angle glaucoma)
- •Diagnosis of PEG (pseudoexfoliation glaucoma)
- •Diagnosis of PDG (pigment dispersion glaucoma)
- •Diagnosis of NTG (normal tension glaucoma)
- •Agreement of patients to participate in the study
排除标准
- •Previous glaucoma surgery
- •Visual acuity of Nulla Lux
- •Poor general condition
- •Pregnancy
- •Exudative macular degeneration
结局指标
主要结局
Visual field progression (mean deviation, MD) 1 month postoperative, 3 months postoperative, 6 months and 12 months postoperative after PreserFlo MicroShunt Implantation.
时间窗: Visual fields taken at baseline should be compared to visual fields 1 month postoperativ, 3 months postoperative and 1 year postoperative.
Visual fields of patients at baseline preoperative and 1 month postoperative, 3 months postoperative, 6 months postoperative and 12 months postoperative should be compared.
Intraocular pressure will be taken 1 month, 3 months, 6 months and 12 months after PreserFlo MicroShunt Implantation.
时间窗: The intraocular pressure will be taken postoperative after one month, 3 months, 6 months and 12 months.
The evaluation of the intraocular pressure shall be done 1 month, 3 months, 6 months and 12 months after surgery.
RNFL (retinal nerve fiber layer) at baseline before sugery and changes after1 month, 3 months, 6 months and 12 months postoperative after PreserFlo MicroShunt Implantation will be evaluated.
时间窗: The measurement of the nerve fiber index shall be done at baseline before surgery and 1 month, 3 months, 6 months and 12 months after surgery.
The measurement of the nerve fiber will be compared at baseline before surgery to the values at 1 month, 3 months, 6 months and 12 months after surgery.
次要结局
未报告次要终点
研究者
Yosuf El-Shabrawi
Prim. Univ. Prof. Dr. Yosuf El-Shabrawi
Klinikum Klagenfurt am Wörthersee