Evaluation of Corneal Endothelium Following Phacoemulsification in Diabetic and Non-diabetic Patients With Pseudoexfoliation Syndrome by Specular Microscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 2
- 主要终点
- coefficient of variation (CV)
研究概览
简要总结
Our study is a comparative study, that was conducted to evaluate the corneal endothelial cells changes and central corneal thickness after uncomplicated phacoemulsification and intra ocular lens (IOL) implantation in normal controls, in non-diabetic and diabetic patients with PEX, and in patients with PEX only using specular microscopy.
详细描述
Our study is a comparative study that included 4 groups (controls, patients with PEX, non-diabetic patients with PEX, diabetic patients with PEX) to evaluate the corneal endothelial cells changes and central corneal thickness after uncomplicated phacoemulsification and intra ocular lens (IOL) implantation using specular microscopy, over a 6 months follow up period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Senile cataract with age between 50 to 70 years
- •Clear cornea with no zonuler dehiscence
- •Lens opacity classification system III (LOCS III), with grade 2-3 nuclear cataract with any additional cortical (C) and posterior sub capsular (P)
排除标准
- •Uncontrolled DM in diabetic groups
- •Presence of autoimmune diseases
- •Patients with glaucoma
- •Corneal guttata
- •Zonular dehiscence
- •Rupture posterior capsule during cataract surgery
结局指标
主要结局
coefficient of variation (CV)
时间窗: 6 months
indicator of the uniformity of the size of endothelial cells
Percentage of hexagonal cells
时间窗: 6 months
indicator of healthy endothelial cells
Central corneal thickness
时间窗: 6 months
measurement of the distance between the epithelium and endothelium at the central cornea
endothelial cell density
时间窗: 6 months
number of endothelial cells
次要结局
未报告次要终点
研究者
Heba Radi AttaAllah
Associate Professor of Ophthalmology
Minia University