Liquefaction Versus Torsional ip. A Comparative Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Endothelial cell count (ECC)
研究概览
简要总结
Objective of this study is the comparative assessment of the impact of torsional and liquefaction technologies on endothelial cells (ECC), corneal edema (CCT) and corneal sensitivity (CCS) in a sample of cataract patients.
Participants were recruited from the Cataract Service of the UHA in a consecutive-if-eligible basis. Eligibility criteria included diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale [10]. By means of a custom computer randomization program all participants randomly populated two study groups according to the cataract-extraction technology used: a) Torsional group (TG) and b) Liquefaction group (LG).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale
排除标准
- •Endothelial cell count less than 1900,
- •glaucoma,
- •IOP-lowering medications,
- •former incisional surgery,
- •former diagnosis of corneal disease,
- •diabetes or autoimmune diseases
结局指标
主要结局
Endothelial cell count (ECC)
时间窗: 1 month postoperatively
次要结局
- Uncorrected visual acuity (UVA)(1 month postoperatively)
- Central corneal thickness (CCT)(1 month postoperatively)
- Central Corneal Sensitivity (CCS)(1 month postoperatively)
研究者
Georgios Labiris
Senior Lecturer
Democritus University of Thrace