Mobile Clinic - a Cross-sectional Epidemiological Survey

Completed

• Conditions: Age Related Macular Degeneration

• Registration Number: NCT02055612
• Lead Sponsor: Novartis Slovakia, s.r.o.

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.

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 Timeline

• Study Start: 2013-03
• Primary Completion: 2013-05
• Study Completion: 2013-07
• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-04
• Study First Posted: 2014-02-05
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-28
• Last Update Posted: 2017-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3278

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Novartis Slovakia, s.r.o.; 🇸🇰 Bratislava, Slovakia