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Mobile Clinic - a Cross-sectional Epidemiological Survey

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ClinicalTrials.gov Identifier: NCT02055612
Recruitment Status : Completed
First Posted : February 5, 2014
Last Update Posted : March 1, 2017
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Slovakia, s.r.o. )

Study Description
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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.

Condition or disease
Age Related Macular Degeneration

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 Design
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Study Type : Observational
Actual Enrollment : 3278 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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 Start Date : March 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02055612


Locations
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Slovakia
Novartis Slovakia, s.r.o.
Bratislava, Slovakia, 821 04
Sponsors and Collaborators
Novartis Slovakia, s.r.o.
Investigators
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Principal Investigator: Vladimir Krasnik, M.D., PhD. Ophthalmology Clinic of Faculty of Medicine of Comenius University and Bratislava University Hospital
More Information
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Responsible Party: Novartis Slovakia, s.r.o.
ClinicalTrials.gov Identifier: NCT02055612    
Other Study ID Numbers: CRFB002ASK01 EPI
First Posted: February 5, 2014    Key Record Dates
Last Update Posted: March 1, 2017
Last Verified: February 2017
Keywords provided by Novartis ( Novartis Slovakia, s.r.o. ):
wet AMD
epidemiology
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases