Mobile Clinic - a Cross-sectional Epidemiological Survey

Age Related Macular Degeneration Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02055612
• Other study ID #: CRFB002ASK01 EPI
• Status: Completed
• Phase: N/A
• First received: February 4, 2014
• Last updated: February 28, 2017
• Start date: March 2013
• Est. completion date: July 2013

Study information

• Verified date: February 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3278
• Est. completion date: July 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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, Trencín, 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

Related Conditions & MeSH terms

• Age Related Macular Degeneration
• Macular Degeneration

Locations

Country	Name	City	State
Slovakia	Novartis Slovakia, s.r.o.	Bratislava

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Slovakia, s.r.o.

Country where clinical trial is conducted

Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Other eye diseases during screening process		participants screened each day 8 hours during a 2 months period in selected areas according to protocol criteria