Clincosm LogoSign in Get a demo

Mobile Clinic - a Cross-sectional Epidemiological Survey

Sponsor
Novartis Slovakia, s.r.o. (Industry)
Overall Status
Completed
CT.gov ID
NCT02055612
Collaborator
(none)
3,278
Enrollment
1
Location
4
Duration (Months)
817.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    3278 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official 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
    Study Start Date :
    Mar 1, 2013
    Actual Primary Completion Date :
    May 1, 2013
    Actual Study Completion Date :
    Jul 1, 2013

    Outcome Measures

    Primary Outcome Measures

    1. Aged specific prevalence of aged-related macular degeneration [participants screened each day 8 hours during a 2 months period in selected areas according to protocol criteria]

    Secondary Outcome Measures

    1. 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]

    2. 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]

    3. 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]

    4. Other eye diseases during screening process [participants screened each day 8 hours during a 2 months period in selected areas according to protocol criteria]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    55 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Adult patients (aged≥55 years) from selected areas in Slovak Republic

    2. 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)

    3. Patient´s informed consent signed.

    Exclusion Criteria:
    • Patients who do not meet the inclusion criteria

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Novartis Slovakia, s.r.o. Bratislava Slovakia 821 04

    Sponsors and Collaborators

    • Novartis Slovakia, s.r.o.

    Investigators

    • Principal Investigator: Vladimir Krasnik, M.D., PhD., Ophthalmology Clinic of Faculty of Medicine of Comenius University and Bratislava University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novartis Slovakia, s.r.o.
    ClinicalTrials.gov Identifier:
    NCT02055612
    Other Study ID Numbers:
    • CRFB002ASK01 EPI
    First Posted:
    Feb 5, 2014
    Last Update Posted:
    Mar 1, 2017
    Last Verified:
    Feb 1, 2017
    Keywords provided by Novartis Slovakia, s.r.o.
    wet AMD
    epidemiology
    Additional relevant MeSH terms:
    Macular Degeneration

    Study Results

    No Results Posted as of Mar 1, 2017