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临床试验/NCT05190965
NCT05190965Unknown不适用

Comparison Between Findings in Optical Coherence Tomography Angiography and in Fluorescein Angiography in Patients With Diapetic Retinopathy

Assiut University0 个研究点目标入组 40 人开始时间: 2022年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
主要终点
Compare findings in OCTA.Ffa in DR

研究概览

简要总结

Diabetic retinopathy (DR) is the leading cause of decreased vision in working age people. Patients with DR can develop macular edema and proliferative retinopathy which are major causes of visual impairment [1]. The potential of OCTA regarding diagnosis and follow up of DR has been shown in previous studies [2-4]. At present fluorescein angiography (FA) represents the gold standard in the diagnosis and staging of DR [5]. With FA vascular lesions like micro aneurysms (MAs), the size of areas of non-perfusion and of the foveal avascular zone (FAZ) and retinal neovascularisations can be reliably identified [6]. Al-though the capabilities of FA are well known, its use also contains some risks related to the intravenous injection of the dye, which can cause nausea, vomiting and allergic re actions and even anaphylactic shock [7]. Besides that, it also requires time and trained personnel [8]. Image acquisition by OCTA in contrast is not as time consuming and can be performed without taking any risks. Additionally, it provides a 3 dimensional cross sectional view of the retinal and choroidal layers with micro meter depth resolution, providing depth selective information of the retinal vasculature. This facilitates accurate diagnosis and follow up of retinal vascular diseases since significant insights into both morphology and perfusion status can be obtained simultaneously. Although various artifacts appear in OCTA images, a qualitative assessment is mostly possible [9].Early changes to be seen in OCTA in patients with non-proliferative DR are vascular remodelling bordering the FAZ, vascular tortuosity, narrowing of capillary lumen and capillary dilatation. These changes cannot be seen in the same manner in FA [10].In this study we investigated the size of the FAZ and the count of MAs in patients with DR.

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
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All Pts with confirmed type 2 diabetes of at least 6 months. Best corrected visual Acuity of 6/60 or higher (using asnellen chart) in each eye

排除标准

  • Dense media opacities interfere with image FFA as dense cataract . Previous TTT mainly retinal laser photocoagulation or intra vitreal injection. History of ocular disease as glaucoma and retinal vascular occlusion . Previous ocular surgery.

结局指标

主要结局

Compare findings in OCTA.Ffa in DR

时间窗: Baseline

Number of microaneurysm.degree of ischemia.size of FAZ

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Esraa Reda Mohamed Mahmoud

E.r.mohamed

Assiut University

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