- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02055612
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
Conditions
Detailed Description
It´s cross-sectional epidemiological survey, multi-centric, non-interventional
- Patients will fill a questionnaire with demography data, anamnesis, risk factors.
- Patients will be assessed by using Amsler grid.
- 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.
- 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
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Bratislava, Slovakia, 821 04
- Novartis Slovakia, s.r.o.
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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:
- Adult patients (aged≥55 years) from selected areas in Slovak Republic
- 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)
- 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
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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
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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
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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
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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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
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.
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