Mobile Clinic - a Cross-sectional Epidemiological Survey

February 28, 2017 updated by: Novartis Slovakia, s.r.o.

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

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.

Study Overview

Status

Completed

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 Type

Observational

Enrollment (Actual)

3278

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Bratislava, Slovakia, 821 04
        • Novartis Slovakia, s.r.o.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Adults from general population across Slovak Republic over 55 years of age, predominantly with home base far than 35 km from nearest retina center

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
participants screened each day 8 hours during a 2 months period in selected areas according to protocol criteria

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

February 4, 2014

First Submitted That Met QC Criteria

February 4, 2014

First Posted (Estimate)

February 5, 2014

Study Record Updates

Last Update Posted (Actual)

March 1, 2017

Last Update Submitted That Met QC Criteria

February 28, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Other Study ID Numbers

  • CRFB002ASK01 EPI

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Age Related Macular Degeneration

3
Subscribe