Effect of Diabetic Retinopathy and its treatment on Macular Capillary Network Density
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- To assess changes in the Macular Capillary Vessel Density in patients with Diabetic Retinopathy and following treatment
研究概览
简要总结
India is diabetic capital of world, with prevalence reaching nearly 70 million by 2025. Diabetes mellitus (DM) is a chronic metabolic disorder with several related systemic complication. Diabetic retinopathy (DR) is a common and specific microvascular complication of DM. Incidence of DR is on a rise and it nearly affects one third of patients with DM.
DR is a microangiopathy characterized by pericyte loss, thickening of basement membrane, formation of microaneurysms, and breakdown of blood retinal barrier.
These microvascular changes leads to capillary occulsion thereby causing retinal non-perfusion.
DR is the leading cause of preventable blindness and early detection and treatment is the only means of preventing it. Optical Coherence Tomography Angiography(OCTA) is a new imaging modality, which can detect these retinal microvascular changes at an early stage even before it’s clinical manifestation.
In our study we would quantify these changes in macular capillary vessel density in diabetic patients as compared to healthy population and also if any change is seen following specific DR treatment. And also assess the association between vessel density and visual acuity and that with levels of HbA1c and changes in the central retinal thickness.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients within Age group of 30 years to 60 years 2.Patients with Non-Proliferative Diabetic Retinopathy (NPDR)(Both Type1 and Type2 Diabetes Mellitus)
- •Patients with Diabetes with no evidence of Diabetic Retinopathy 4.Patients with NPDR with Centre involving Macular Edema undergoing treatment.
排除标准
- •Patients with Proliferative Diabetic Retinopathy(PDR)
- •Patients with Non-centre involving Macular Edema
- •Clinical evidence of other ocular or retinal pathology
- •Patients undergone previous treatment(Intravitreal injection or laser)
- •Patients with diabetic Tractional retinal detachement or Complete retinal detachment (TRD/CRD).
结局指标
主要结局
To assess changes in the Macular Capillary Vessel Density in patients with Diabetic Retinopathy and following treatment
时间窗: baseline and 6 months
次要结局
- 1. To assess if there is any association between vessel density and HbA1c levels(2. To evaluate association of vessel density with visual acuity)