Evaluation of outcome of two different Ophthalmic viscosurgical devices 3 percent Sodium Hyaluronate and 4 percent Chondroitin sulphate vs 2 percent Hydroxy propyl methyl cellulose on endothelial cell count in Phacoemulsifiction cataract surgery in Diabetics
概览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- Sankara eye hospital Guntur
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Endothelial Cell Count decrease to be evaluated in both groups of Ophthalmic Viscosurgical Devieces
概览
简要总结
The study is a prospective interventional randomized control trial evaluating the effects of 3 percent Sodium Hyaluronate and 4 percent Chondroitin Sulphate vs 2 percent Hydroxy Propyl Methyl Cellulose on Endothelial cell count in 80 diabetic patients above 50 years of age undergoing Phacoemulsification cataract surgery in one center in Guntur India. The primary outcomes measure will all show decrease in endothelial cell count in 1 week,1 month and 3 months. The secondary outcome will show increase in Central corneal thickness in 1 week,1 month and 3 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Grade of cataract- Nuclear sclerosis 1,2,3 and posterior subcapsular cataract 1,2,3,4 cortical cataract 1,2,3,4 by Lens Opacities Classification System(LOCS 3) Pre operative Specular count>2000 cells/mm2 Uneventfull cataract surgery Diagnosed with Type2 DM.
排除标准
- •Grade of cataract-Nuclear Sclerosis 4,5,6 posterior subcapsular cataract 5 cortical cataract 5 (Lens Opacities Classification System Grading 3) Corneal pathologies like fuchs endothelial dystrophy Ocular pathology like Uveitis, pseudoexfoliation, glaucoma Trauma Previous eye surgery Small rigid pupil(less than 5 mm) Subluxated cataract Complicated cataract Study subjects lost to follow-up.
结局指标
主要结局
Endothelial Cell Count decrease to be evaluated in both groups of Ophthalmic Viscosurgical Devieces
时间窗: Endothelial Cell Count decrease to be evaluated in both groups of Ophthalmic Viscosurgical Devieces at baseline, 1 week,1 month,3 months
次要结局
- Central corneal thickness increase to be evaluated in both groups of Ophthalmic viscosurgical devices(Central corneal thickness increase to be evaluated in both groups of Ophthalmic viscosurgical devices at baseline , 1 week,1 month,1 month)
研究者
NALIN SAH
SANKARA EYE HOSPITAL GUNTUR