Peking University Third Hospital Medical Science Research Ethics Committee
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Silt-lamp examination of the cornea
研究概览
简要总结
To evaluate the effectiveness and safety of tacrolimus eye drops (FK-506) in the treatment of Posner-Schlossman Syndrome. It is expected to collect 30 patients with PSS who are in the Ophthalmology Department of Peking University Third Hospital. The included PSS patients were divided into experimental group and control group using simple randomization method. Among them, the experimental group was treated with FK-506 twice a day, and the control group was treated with prednisolone acetate ophthalmic suspension 1% 4 times a day.
For all PSS patients whose intraocular pressure is higher than 30mmHg, also add brinzolamide eye drops 3 times a day. Best corrected visual acuity, Goldmann intraocular pressure, anterior section photographs, corneal endothelial cells，corneal confocal microscope, Heidelberg retinal nerve analysis, Octopus visual field were examined on baseline and 1 week, 2 weeks, 3 weeks, 4 weeks after the treatment.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of PSS Must be able to communicate with doctor and understand this study
排除标准
- •Fuchs syndrome
研究组 & 干预措施
The experimental group
干预措施: FK-506 (Drug) (Drug)
The control group
干预措施: Prednisolone Acetate 1% Oph Susp (Drug)
结局指标
主要结局
Silt-lamp examination of the cornea
时间窗: 4 weeks after the treatment
KP numbers after the treatment
次要结局
- Goldmann ophthalmotonometer examination of intra-ocular pressure(4 weeks after the treatment)
研究者
Chun Zhang
Professor
Peking University