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临床试验/NCT06434155
NCT06434155已完成不适用

Social History and Glaucoma Progression: The Effect of Body Mass Index, Tobacco, and Alcohol Consumption on the Rates of Structural Change in Patients With Open Angle Glaucoma

Assiut University1 个研究点 分布在 1 个国家目标入组 1,584 人开始时间: 2022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
入组人数
1,584
试验地点
1
主要终点
OCT structural parameters

研究概览

简要总结

The objective of this study is to predict of glaucoma progression. By imaging of the retinal nerve fiber layer RNFL, optic nerve head (ONH) and macular measurements using spectral-domain OCT (SD-OCT) instruments

详细描述

Glaucoma is a multifactorial optic neuropathy characterized by structural damage of retinal ganglion cells (RGCs) and their axons that is associated with vision loss and may lead to irreversible blindness. Because glaucomatous damage is irreversible and effective treatment is available to halt further damage, glaucoma management should be optimized with precise micrometer-scale quantifications of ocular structures that improve detection of the disease and its progression. The introduction of OCT technology more than 20 years ago provided in vivo detailed visualization of the optic nerve head (ONH) and retina and enabled the quantitative evaluation of these tructures. Circumpapillary retinal nerve fiber layer (RNFL) thickness is a common OCT measurement that provides comprehensive evaluation of all RGCs in an eye as they converge into the ONH.

When measured with spectral-domain OCT, the RNFL has been shown to differentiate between healthy and glaucomatous eyes. The steady evolution of OCT technology has led to imaging with better resolution, higher scanning speeds, and advanced imaging patterns that has improved the reliability of OCT measurements and allowed for detection of minute changes that can improve the sensitivity of progression detection. Assessment of glaucoma progression usually is based on event or trend analysis. Event-based progression determines when a measurement exceeds a pre-established threshold for change from baseline. Trend-based analysis quantifies the rate of a parameter's progression over time.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • IOP measurements more than 21 mmHg
  • Open angle on gonioscopy (Grade 3 or 4 on Schaffer grading system for angle width)
  • Glaucomatous visual field defects consistent with glaucomatous optic disc changes.
  • Eyes with baseline macular and ONH OCT images and ONH photograps

排除标准

  • Participants with significant retinal disease.
  • non-glaucomatous optic neuropathy.
  • anomalous discs
  • any retinal pathology.
  • history of cataract or glaucoma surgery will not be exclusion criteria.

结局指标

主要结局

OCT structural parameters

时间窗: 6 months

RNFL in (um), ONH in (um), as well as the inner macula thickness (in um) using spectral domain OCT

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

Khaled Abdelazeem

Associate Professor

Assiut University

研究点 (1)

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