Effect of Intracameral Steroids Injection During Phacoemulsification on Postoperative Corneal Edema and Corneal Endothelium
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Central corneal thickness (CCT)
研究概览
简要总结
Prospective, interventional case control study. Sixty-nine eyes were randomized into 3 groups, 23 eyes each : 2groups received intracameral dexamethasone and triamcinolone (TA) respectively, while controls didn't receive any intraoperative steroids.
Intracameral steroids at the conclusion of phacoemulsification significantly improved corneal edema and spared corneal endothelium.
详细描述
Purpose: Investigating the effect of intracameral steroids at the end of phacoemulsification on corneal edema and endothelial count.
Methods: Prospective, interventional case control study. Sixty-nine eyes were randomized into 3 groups, 23 eyes each : 2groups received intracameral dexamethasone and triamcinolone (TA) respectively, while controls didn't receive any intraoperative steroids.
On the first postoperative day corneal edema in control compared to dexamethasone and TA groups respectively.
One month later, the mean increase of corneal thickness in control compared to intracameral dexamethasone and TA groups, respectively.
mean endothelial cell loss in control compared to intracameral dexamethasone and TA groups respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cataract grades 2 to 5 nuclear cataract (LOCS III scale)
- •uneventful phacoemulsification operation
排除标准
- •extremely hard cataract grade 6 nuclear cataract (LOCS III scale)
- •soft cataract
- •subluxated lenses or zonular dehiscence
- •associated ocular pathology such as glaucoma
- •any signs of uveitis
- •retinal detachment
- •vitrectomized or silicone filled eyes
- •corneal disease such as Fuch's dystrophy, corneal opacity
- •previous refractive corneal surgery
- •Cases that developed ruptured posterior capsule and vitreous loss
- •those lost to follow up were excluded and randomly replaced by the next chronological patient
研究组 & 干预措施
Control group 1
23 eyes that did not receive any intraoperative steroids
干预措施: Control group (Other)
Dexamethasone group 2
23 eyes that received intracameral dexamethasone
干预措施: Dexamethasone group (Drug)
Triamcinolone (TA) group 3
23 eyes that received intracameral triamcinolone (TA)
干预措施: Triamcinolone (TA) group (Drug)
结局指标
主要结局
Central corneal thickness (CCT)
时间窗: Three months
Central corneal thickness in microns after phacoemulsification that was compared to preoperative values
Endothelial cell loss
时间窗: Three months
Corneal endothelial cell count (cell/ square mm) after phacoemulsification that was compared to preoperative values
Corneal edema
时间窗: First day postoperative
Clinical grade of corneal edema on the first postoperative day
次要结局
- IOP(Three months)
研究者
khaled gamal abueleinen
professor
Cairo University