Mobile Clinic - a Cross-sectional Epidemiological Survey

NCT ID: NCT02055612

Last Updated: 2017-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

3278 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2013-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Age Related Macular Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Slovakia, s.r.o.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Vladimir Krasnik, M.D., PhD.

Role: PRINCIPAL_INVESTIGATOR

Ophthalmology Clinic of Faculty of Medicine of Comenius University and Bratislava University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Novartis Slovakia, s.r.o.

Bratislava, , Slovakia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Slovakia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CRFB002ASK01 EPI

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

CRYSTALSIGHT Cohort 2.0
NCT07255859 RECRUITING NA