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临床试验/NCT04582110
NCT04582110已完成不适用

Retinal and Choriocapillaris Vascular Features in Patients With Beta Thalassemia by Means of Optical Coherence Tomography Angiography

Federico II University1 个研究点 分布在 1 个国家目标入组 82 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
82
试验地点
1
主要终点
The measurements of retinal and choriocapillaris features in patients with Beta Thalassemia, using optical coherence tomography angiography.

研究概览

简要总结

To investigate, using optical coherence tomography angiography (OCTA), the retinal and choriocapillaris vascular features in patients affected by Beta Thalassemia. Moreover we analyzed the structural retinal parameters (ganglion cell complex and retinal nerve fiber layer), using optical coherence tomography (OCT) in these patients

详细描述

Beta Thalassemia is one of the most common genetic hemoglobinopathy characterized by a defective β globulin chain synthesis leading to hemolysis and ineffective erythropoiesis.

The study investigated the changes in retinal and choriocapillaris vascular features using optical coherence tomography angiography, a novel and noninvasive diagnostic technique that allows a detailed analysis of retinal and choriocapillaris blood flow.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
35 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • age older than 35 years
  • diagnosis of Beta Thalassemia
  • absence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
  • absence of significant lens opacities, low-quality OCT and OCT-A images.

排除标准

  • age older than 50 years
  • absence of diagnosis of Beta Thalassemia
  • presence of previous ocular surgery, congenital eye disease, high myopia (>6 dioptres), actual or previous diagnosis of glaucoma, optic disc anomaly, macular or vitreoretinal diseases.
  • presence of significant lens opacities, low-quality OCT and OCT-A images.

结局指标

主要结局

The measurements of retinal and choriocapillaris features in patients with Beta Thalassemia, using optical coherence tomography angiography.

时间窗: Four months

The parameters analyzed by optical coherence tomography angiography were: retinal and choriocapillaris vessel density

次要结局

  • The measurements of retinal structural parameters in patients with Beta Thalassemia, using optical coherence tomography.(Four months)

研究者

发起方
Federico II University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gilda Cennamo

Principal Investigator

Federico II University

研究点 (1)

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