The Effect of Antiglaucoma Procedures (Trabeculectomy vs. Ex-PRESS Glaucoma Drainage Implant) on the Corneal Biomechanical Properties
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 主要终点
- Change of corneal biomechanical properties
研究概览
简要总结
This study aims to look into the change of the corneal biomechanical properties in patients undergoing insertion of the Ex-PRESS mini shunt or trabeculectomy for medically uncontrolled glaucoma
详细描述
The patients in the study were divided into two groups. In group 1 the patients had the Ex-PRESS mini shunt inserted in the operated eye and in group 2 the patients underwent standard trabeculectomy.
The corneal biomechanical properties were measured with the Ocular Response Analyzer before surgery and at 1, 6 and 12 months after surgery. The corneal biomechanical properties measured were the Corneal Hysteresis (CH) and the Corneal Resistance Factor (CRF).
The change of the CH and CRF was compared in each group before and after surgery (at the aforementioned predetermined time points) and between the two groups.
The intraocular pressure was also measured with the Goldmann applanation tonometer at the same time points and the change was compared before and after surgery in each group and between the two 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18
- •Average Intraocular pressure > 24 mmHg on at least 2 occasions 1 month before surgery
- •Congenital glaucoma
排除标准
- •Previous ocular trauma
- •Previous ocular surgery other than phacoemulsification
- •Previous disease of the ocular surface
结局指标
主要结局
Change of corneal biomechanical properties
时间窗: 12 months
Two corneal biomechanical properties were measured with the use of the Ocular Response Analyzer (ORA): the Corneal Resistance Factor (CRF) and the Corneal Hysteresis (CH). These two indicators were measured before surgery and at 1, 6 and 12 months after surgery
次要结局
- Change of Intraocular Pressure(12 months)
研究者
Georgios Labiris
Professor (Associate) of Democritus University of Thrace
Democritus University of Thrace