OCT Angiography Changes in Patients With Diabetes Mellitus Type 2 With and Without Diabetic Retinopathy Undergoing Phacoemulsification
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Detecting changes in the retinal vascular plexuses and choriocapillaris after cataract surgery in type 2 diabetes mellitus patients with and without diabetic retinopathy using OCT angiography.
研究概览
简要总结
Detecting the influence of cataract surgery on the development of diabetic retinopathy in patients with diabetes mellitus type 2 with and without diabetic retinopathy using OCT angiography.
详细描述
Patients with diabetes mellitus type 2 with and without without diabetic retinopathy (on biomicroscopy examination) who need cataract surgery, will undergo OCT angiography examination prior to their cataract surgery. Average vessel density (%) in superficial capillary plexus, deep capillary plexus and choriocapillaris, parafoveal vessel density (%) in the superficial and deep plexuses, FAZ area (mm2) in the superficial capillary plexus, FAZ circularity, retinal thickness, microaneurysms and capillary non-perfusion will be taken into analysis.
Patients will be examined on the first day after the cataract surgery with phacoemulsification and in the bag posterior chamber lens implantation.
All patients will undergo OCT angiography examination four weeks after their cataract surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diabetes mellitus type 2 with and without diabetic retinopathy who needs cataract surgery.
- •Patients who need cataract surgery without any intravitreal injections.
- •Absence of any ocular disease other than diabetes mellitus.
- •Cataract density allowing good visualization of the fundus by OCT angiography.
- •Patients with uneventful cataract surgery with phacoemulsification.
排除标准
- •Patients who fail to comply with the follow-up schedule.
- •Very dense cataract not allowing good visualization of the fundus by OCT angiography.
- •Patients with complicated cataract surgery with phacoemulsification.
- •Patients who need cataract surgery with any intravitreal injection.
结局指标
主要结局
Detecting changes in the retinal vascular plexuses and choriocapillaris after cataract surgery in type 2 diabetes mellitus patients with and without diabetic retinopathy using OCT angiography.
时间窗: 1 month
Changes in the retinal vascular plexus, superficial and deep vessel density, foveal avascular zone area, circularity and any developing microaneurysms and areas of retinal ischemia will be measured to see the influence of cataract surgery on diabetic retinopathy.
次要结局
未报告次要终点
研究者
Abeer Tawfik Al Hanaineh
Doctor
Cairo University