Viscoat Versus Visthesia. A Comparative Study of Post-cataract Endothelial Cell Loss
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Endothelial Cell Count (ECD)
研究概览
简要总结
Objective of this study is the comparative assessment of the beneficial impact of the Viscoat viscoelastic (OVD) and Visthesia OVD on endothelial cells and corneal edema following torsional-ip cataract extraction surgery.
Participants will be recruited from the Cataract Service of the University Hospital of Alexandroupolis (UHA) in a consecutive-if-eligible basis. Eligibility criteria include diagnosis of senile cataract with stage 3 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale. By means of a custom computer randomization program all participants will randomly populate two study groups according to the OVD used (ie. viscoat or visthesia).
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 85 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 3 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
研究组 & 干预措施
Viscoat group
Patients operated using Viscoat OVD
干预措施: Viscoat (Procedure)
Visthesia group
Patients operated using Visthesia OVD
干预措施: Visthesia (Procedure)
结局指标
主要结局
Endothelial Cell Count (ECD)
时间窗: 3 months postoperatively
次要结局
- Endothelial Cell pattern (ECP)(3 months postoperatively)
- Central corneal edema (CCE)(3 months postoperatively)
研究者
Georgios Labiris
Assistant Professor
Democritus University of Thrace