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临床试验/NCT04135209
NCT04135209已完成不适用

Evaluation of Macular Microvasculature in High Myopia Using Optical Coherence Tomography Angiography

Minia University1 个研究点 分布在 1 个国家目标入组 55 人开始时间: 2018年1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
55
试验地点
1
主要终点
Difference in angiography between the 2 groups

研究概览

简要总结

The aim of this study is to investigate the macular microvascular network alterations in high myopic eyes using optical coherence tomography angiography.

详细描述

High myopia is defined as a refractive error equal to or more than -6 D, and/or axial length equal to or more than 25.5 mm².Axial elongation of the globe and subsequent stretch of the retina leads to sight threatening complications.

Quantitative measurements of retinal vasculature in the healthy eye have been reported using several in vivo and in vitro techniques, including confocal microscopy, fluorescein angiography (FA), and swept-source optical coherence tomography (ssOCT) angiography.

The aim of this study is to investigate the macular microvascular network alterations in high myopic eyes using optical coherence tomography angiography.

This cross-sectional prospective study included 75 eyes of 54 patients, they were recruited from the outpatient clinic of ophthalmology department of El-Minia university hospital.They were divided into two groups, group A included 25 normal eyes of 25 patients. Group B included 50 myopic eyes of 30 patients.

All patients subjected to history taking and full ophthalmological examination in addition to axial length measurment before performing OCTA.

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
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • Highly myopic subjects, defined as those with spherical equivalents (SEs) of -6 or more, with axial length greater than 26.5 mm.
  • Group B individuals were chosen among healthy age-matched controls.

排除标准

  • • Patients younger than 18 years old, or older than 45 years.
  • Any patient with macular pathology (e.g. diabetic retinopathy, hypertensive retinopathy, dystrophy)
  • Myopic patients with any vitro-retinal abnormalities (e.g. choroidal neovascular membrane (CNVM), foveoschisis,macular hole)
  • Patients who underwent previous intra ocular surgical procedures.
  • Patients with previous history of intraocular injections.
  • Glaucomatous patients.
  • Exclusion criteria to the images that has been captured:
  • - Low signal strength index (less than 50).
  • - Presence of blink artefacts.
  • - Poor fixation leading to motion or doubling artefacts.
  • - Media opacity obscuring view of the vasculature.
  • - Segmentation error due to cystoid macular oedema or epi-retinal membrane, among others.

结局指标

主要结局

Difference in angiography between the 2 groups

时间窗: through study completion, an average of 4 weeks

The difference of the volumetric data generated automatically from the OCTA machine at the 3 levels, (the inner retina, outer retina and the choriocapillaris) in three zones (the fovea, the parafovea and the whole image)

次要结局

未报告次要终点

研究者

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

M. Tarek A. Moustafa

Lecturer of Ophthalmology

Minia University

研究点 (1)

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