An interventional study to see optical coherence tomography angiography biomarkers changes after cataract surgery on macula in diabetic retinopathy with no diabetic macular edema
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare these parameters in diabetic patients and non diabetic patients before and after cataract surgery using Optical Coherence Tomography Angiography-:
研究概览
简要总结
Diabetes is a most prevelent disease affecting 425million people worldwide. Diabetes causes many ocular complications., such as cataract and diabetic retinopathy which are the main causes of decreased vision in diabetic patients and often coexists. The principle pathogenesis of diabetic retinopathy is the breakdown of the BRB.
In this study we used OCTA to asses the macular thickness , superficial and deep vascular densities ,FAZ , and chorodial thickness in diabetic and nondiabetic patients after cataract surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •(A) For Diabetic Patients :
- •Diabetic retinopathy patients with immature senile cataract who require phacoemulsification surgery
- •Intraocular pressure between 10-21 mmHg
- •Given written informed consent
- •Age between 50-80 yrs (B) For Non diabetic patients (control group):
- •Patients with immature senile cataract who require phacoemulsification surgery
- •Age between 50-80 yrs.
排除标准
- •Eyes with Diabetic Macular Edema .
- •Eyes with Intraocular pressure higher than 21mmHg. Eyes with mature , posterior sub capsular and posterior polar cataract History of retinal laser or intravitreal injection.
结局指标
主要结局
To compare these parameters in diabetic patients and non diabetic patients before and after cataract surgery using Optical Coherence Tomography Angiography-:
时间窗: baseline before cataract surgery | 7 days | 1 month | 3 months
a) Macular thickness
时间窗: baseline before cataract surgery | 7 days | 1 month | 3 months
b) Superficial capillary vessel density
时间窗: baseline before cataract surgery | 7 days | 1 month | 3 months
c) Superficial capillary plexus perfusion density
时间窗: baseline before cataract surgery | 7 days | 1 month | 3 months
d) Chorodial thickness
时间窗: baseline before cataract surgery | 7 days | 1 month | 3 months
e) Foveal avascular zone
时间窗: baseline before cataract surgery | 7 days | 1 month | 3 months
次要结局
- 1. To see correlation between macular thickness and superficial capillary plexus (SCP) vessel density that occurs due to cataract surgery.(2. To see correlation of macular thickness and superficial capillary plexus (SCP) vessel density with Best Corrected Visual Acuity.)
研究者
DR Kavita Bajiya
SMS Medical College Jaipur Rajasthan