A comparative study of the effect of Ripasudil (Rho-kinase inhibitor) on Corneal Endothelial Cell Density (ECD) and Central Corneal Thickness (CCT) in post-operative cataract patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 78
- 试验地点
- 1
- 主要终点
- corneal endothelial cell density (ECD) and central corneal thickness (CCT)
研究概览
简要总结
This study will be done on 78 patients attending ophthalmology OPD in Hindu Rao Hospital, for cataract surgery. The patients will be divided into 2 groups- group A - where Ripasudil eye drop was given post-operatively with standard post operative care for cataract surgery and group -B- where Ripasudil eye drop was not given post-operatively though standard post operative care for cataract surgery was given. All patients will undergo pre-operative and post-operative specular microscopy for endothelial cell density, CCT, HEX and CV {using Topcon Specular Microscope(SP-1P model)} along with complete eye examination. All patients will be examined post-operatively at 1 week, 1 month and 3 month. in follow-up visits, patient will undergo BCVA assessment, NCT, slit-lamp examination, specular microscopy and fundoscopy, which will be documented in preset proforma.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 40.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Senile uncomplicated cataract of up to NS grade III 2.No previous history of intraocular surgery 3.Pre-operative endothelial cell count at least greater than 1500 cells/mm2.
排除标准
- •1.History of previous ocular trauma, surgery, intra-ocular inflammation 2.Diagnosed case of glaucoma 3.Corneal opacity 4.Traumatic cataract 5.Ocular surface disorders (eg.
- •Pterygium) 6.Adenexal diseases (eg.
- •Ectropion, trichiasis) 7.Contact lens wear 8.Pseudo-exfoliation 9.Diabetes 10.Complicated cataract surgery.
结局指标
主要结局
corneal endothelial cell density (ECD) and central corneal thickness (CCT)
时间窗: Pre-operatively | Post-operative 1 week | Post-operative 1 month | Post-operative 3 month
次要结局
- Percentage of hexagonal cells (HEX)(Pre-operatively)
- Coefficient of variation (CV)(Pre-operatively)
研究者
Sumedha
Hindu Rao Hospital
