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临床试验/NCT02055612
NCT02055612已完成不适用

Mobile Clinic- a Cross-sectional Epidemiological Survey to Investigate the Prevalence of Wet Aged-related Macular Degeneration (wAMD) in Elderly Population in Slovak Republic

Novartis Slovakia, s.r.o.1 个研究点 分布在 1 个国家目标入组 3,278 人开始时间: 2013年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
3,278
试验地点
1
主要终点
Aged specific prevalence of aged-related macular degeneration

研究概览

简要总结

The aim of the study is to find out prevalence of aged-related macular degeneration (AMD) in Slovak Republic. The outcome of the project will be epidemiology survey, prevalence of wet form of AMD in relation to demographic data, patient´s anamnesis, nutrition, co-morbidities etc.

详细描述

It´s cross-sectional epidemiological survey, multi-centric, non-interventional

  1. Patients will fill a questionnaire with demography data, anamnesis, risk factors.
  2. Patients will be assessed by using Amsler grid.
  3. Patient´s back of the eye will be examined with fundus camera (searching for long-term back of the eye changes, retina vessels, macula and surrounding tissues) by retina specialist.
  4. Patient undergoes optical coherent tomography (OCT) examination (cross-section of fovea and macula) by retina specialist.

The project actively screen patients with wAMD. All patients will sign an informed consent.

The process of screening will be held in certain timeframe (cca. 2 months) and selected areas of Slovak Republic.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
55 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adult patients (aged≥55 years) from selected areas in Slovak Republic
  • Patients with home base far than 35 km from the nearest center (centers: Bratislava, Nitra, Nové Zámky, Trenčín, Bojnice, Žilina, Martin, Ružomberok, Banská Bystrica, Zvolen, Poprad, Prešov, Košice, Trebišov)
  • Patient´s informed consent signed.

排除标准

  • Patients who do not meet the inclusion criteria

结局指标

主要结局

Aged specific prevalence of aged-related macular degeneration

时间窗: participants screened each day 8 hours during a 2 months period in selected areas according to protocol criteria

次要结局

  • Relation between home distance of the patients with wAMD from the nearest center and availability of heath care(participants screened each day 8 hours during a 2 months period in selected areas according to protocol criteria)
  • Other eye diseases during screening process(participants screened each day 8 hours during a 2 months period in selected areas according to protocol criteria)
  • Social-demography structure of patients with wAMD(participants screened each day 8 hours during a 2 months period in selected areas according to protocol criteria)
  • Risk factors associated with wAMD (e.g. co-morbidities, nutrition effects)(participants screened each day 8 hours during a 2 months period in selected areas according to protocol criteria)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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