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临床试验/NCT00321386
NCT00321386Unknown不适用

Parameters for Disease Progression in Chinese Patients With Normal Tension Glaucoma

Chinese University of Hong Kong2 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2003年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
2

研究概览

简要总结

To obtain demographic and baseline ophthalmic parameters (such as Intraocular Pressure profiles, disc morphological characteristics, central corneal thickness, peripapillary retinal nerve fibre layer thickness and its serial changes, visual field changes, severity of any medical associations-e.g. hypertension, migraine, strokes, silent cerebral infarcts) with non-invasive measurements, in Chinese Patients with Normal Tension Glaucoma

详细描述

This is a multi-centered non-interventional descriptive study. The Declaration of Helsinki is followed. All procedures will be conducted in accordance with the GCP guidelines.

About 100 Consecutive NTG glaucoma patients will be included in this study. NTG is defined as:

  1. Six median untreated intraocular pressure consistently less than 21 mm Hg, with no more than 1 reading = 23 mmHg or 24 mmHg, and with no single measurement greater than 24 mm Hg,
  2. Open drainage angles on gonioscopy,
  3. Typical optic disc damage with glaucomatous cupping and loss of neuroretinal rim,
  4. Absence of any secondary cause for a glaucomatous optic neuropathy (trauma, steroids, uveitis),
  5. Glaucomatous visual field defect compatible with glaucomatous optic neuropathy.

Age and sex-matched normal control subjects and age, sex, severity-matched POAG control subjects will be recruited.

Randomization not required as this will be a non-interventional descriptive study.

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

  • All Chinese patients with age>18 years old with Normal Tension Glaucoma will be recruited

排除标准

  • Diseases that precluded accurate measurement of IOP, visual acuity, retinal nerve fiber layer thickness, and visual field tests.
  • Previous ocular surgery per se is not an exclusion criteria.

研究者

申办方类型
Other

研究点 (2)

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