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临床试验/NCT06000176
NCT06000176已完成不适用

Comparison of Optical Coherence Tomography Angiography Microvascular Changes in Primary Open Angle and Primary Angle Closure Glaucoma

Omar Said1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年4月5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
120
试验地点
1
主要终点
OCTA macula and ONH

研究概览

简要总结

This work aims to study the peripapillary and macular microvascular changes in primary open angle and primary angle closure glaucoma using Optical Coherence Tomography Angiography (OCTA).

详细描述

After approval of the local institutional ethics committee and local institutional review board, all patients presenting to the outpatient clinic of the department of Ophthalmology in the universities has been subjected to routine ophthalmological examination including: best corrected visual acuity (BCVA), Slit-lamp evaluation of anterior segment, IOP by Goldmann applanation tonometer, Gonioscopy using gonio contact lens, Fundus examination by indirect opthalmoscope with history taking focusing on positive family history of glaucoma after a detailed informed consent was signed by eligible patients and investigated by OCTA of the Peripapillary and Macular vascular density on presentation using AngiVue (Optovue, Inc., Fremont, CA, USA).

Data analysis performed using the Statistical Package of Social Science (SPSS) software version 22 in windows 7 (SPSS Inc., Chicago, IL, USA) Simple descriptive statistical analysis in the form of numbers and percentages of qualitative data, and arithmetic means as central tendency measurement, standard deviations as a measure of dispersion of quantitative parametric data.

For quantitative parametric data: Independent samples test was used to compare quantitative measures between two independent groups, One-way analysis of variance ANOVA test used to compare quantitative measures between more than two independent groups of quantitative data with the benferroni Post-HOC to test the significance between each two groups, Paired t-test used to compare two dependent quantitative data.

For qualitative data Chi square test used to compare between two or more than two qualitative groups.

Bivariate Pearson correlation test to test the association between variables The probability value (P-value) < 0.05 was considered as statistical 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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years old.
  • Fulfilling Diagnostic criteria of PACG patients :occluded angle by gonioscopy in which > 180˚ of trabecular meshwork cannot be seen , IOP>21, Optic disc and RNFL damage due to glaucoma
  • Diagnosed POAG patient: open anterior chamber angle ,IOP>21 ,Optic disc and RNFL damage due to glaucoma
  • Healthy patient: normal anterior chamber, open angle and normal fundus.

排除标准

  • History of other causes of optic neuropathy.
  • History of systemic diseases. (HTN, DM, Cardiac).
  • Previous ocular surgeries or Laser iridotomy.
  • Poor quality of OCTA image less than 4/
  • Refractive errors > 6 diopters sphere, >3 diopter cylinder
  • Poor cooperation or fixation with the OCTA examination.
  • Secondary causes of glaucoma
  • Media opacity that interfere with quality of image (dense cataract,corneal opacity,...)
  • Previous acute attack of ACG

结局指标

主要结局

OCTA macula and ONH

时间窗: We will recruit patient that include the inclusion criteria from april2022 to july 2023

macular 6\*6,3\*3 and peripapillary vessel density

次要结局

未报告次要终点

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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