Clinical trial NCT02055612: Mobile Clinic - a Cross-sectional Epidemiological Survey
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age Related Macular Degeneration
Keywords: wet AMD
epidemiology
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2014-02-05
Enrollment: 3278
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Aged specific prevalence of aged-related macular degeneration
timeFrame: participants screened each day 8 hours during a 2 months period in selected areas according to protocol criteria
Secondary outcomes:
measure: Social-demography structure of patients with wAMD
timeFrame: participants screened each day 8 hours during a 2 months period in selected areas according to protocol criteria
measure: Risk factors associated with wAMD (e.g. co-morbidities, nutrition effects)
timeFrame: participants screened each day 8 hours during a 2 months period in selected areas according to protocol criteria
measure: Relation between home distance of the patients with wAMD from the nearest center and availability of heath care
timeFrame: participants screened each day 8 hours during a 2 months period in selected areas according to protocol criteria
measure: Other eye diseases during screening process
timeFrame: participants screened each day 8 hours during a 2 months period in selected areas according to protocol criteria
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Novartis Slovakia, s.r.o.
Study officials:
affiliation: Ophthalmology Clinic of Faculty of Medicine of Comenius University and Bratislava University Hospital
name: Vladimir Krasnik, M.D., PhD.
role: PRINCIPAL_INVESTIGATOR
References: