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临床试验/NCT06031350
NCT06031350已完成不适用

Peripapillary and Macular Vascular Changes of Unilateral Anterior Ischemic Optic Neuropathy: An Optical Coherence Tomography Angiography Study

Omar Said1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年6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
30
试验地点
1
主要终点
Peripapillary and macular vascular changes

研究概览

简要总结

This series aims at studying the peripapillary and macular vascular changes in subjects with unilateral anterior ischemic optic neuropathy via Optical Coherence Tomography Angiography (OCTA).

详细描述

After approval of the local institutional ethics committee and local institutional review board, This study was conducted upon 30 patients diagnosed with acute NAION attending at Ophthalmology outpatient clinic in Fayoum University Hospitals. The participants were informed about the objectives of the study, the examination, investigations and the confidentiality of their information and their right not to participate in the study. OCT and OCTA was done for all subjects and control group with Optovue, Inc., Fremont, CA, USA. Patients were examined on presentation, after 6 weeks and lastly after 3 months. OCT was used for evaluation of Central macular thickness (CMT), nerve fiber layer thickness (NFLT) and ganglion cell complex (GCC). OCTA was done for quantitative evaluation of vessel density in the following: optic nerve head and peripapillary area, macular superficial vessel density, macular deep vessel density and foveal avascular zone. Vessel density was reported as the percentage of the total area that was occupied by blood vessels. All parameters were calculated automatically by the machine software. Poor quality scans and those with motion artifacts were excluded. Statistical analysis was performed using SPSS software (version 22; SPSS, Chicago, IL, USA). The data were presented as the mean ± SD values. P-value <0.05 was considered significant.

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
— 至 40 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with unilateral NAION and acute or sudden painless drop of vision.
  • A normal fellow eye.
  • Age ≥ 40 years old.

排除标准

  • Arteritic type of AION.
  • NAION patients in chronic phase.
  • Acute phase NAION patients with any other optic neuropathy in the other eye.
  • Eyes with opaque media.
  • Elevated intraocular pressure (>22 mmHg).
  • Refractive errors greater than 6 diopters of spherical equivalent.
  • Poor cooperation with fixation or the OCTA examination.

结局指标

主要结局

Peripapillary and macular vascular changes

时间窗: 3 months (0,6,12 weeks)

comparing vessel density in different areas and sectors of diseased and fellow eyes

次要结局

  • Thickness of different retinal layers(3 months (0,6,12 weeks))

研究者

发起方
Omar Said
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Omar Said

Assistant professor of Ophthalmology

Fayoum University

研究点 (1)

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