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Completed

NCT Number: NCT02055612

Mobile Clinic - a Cross-sectional Epidemiological Survey

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.

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Key information

Conditions

Age Related Macular Degeneration Eye Diseases Macular Degeneration Retinal Degeneration Retinal Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Slovakia, s.r.o.

Bratislava, 821 04, Slovakia

About this study

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

  • Patients will fill a questionnaire with demography data, anamnesis, risk factors.
  • Patients will be assessed by using Amsler grid.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • Patients who do not meet the inclusion criteria

Treatment and study plan

Primary outcomes

  1. Aged specific prevalence of aged-related macular degeneration

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

Secondary outcomes

  1. Social-demography structure of patients with wAMD

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

  2. Risk factors associated with wAMD (e.g. co-morbidities, nutrition effects)

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

  3. Relation between home distance of the patients with wAMD from the nearest center and availability of heath care

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

  4. Other eye diseases during screening process

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

Sponsors and collaborators

Lead sponsor

Novartis Slovakia, s.r.o.

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Feb 5, 2014
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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