NCT02055612

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,278

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2014

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

2 months

First QC Date

February 4, 2014

Last Update Submit

February 28, 2017

Conditions

Keywords

wet AMDepidemiology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • 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

  • 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

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novartis Slovakia, s.r.o.

Bratislava, 821 04, Slovakia

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Vladimir Krasnik, M.D., PhD.

    Ophthalmology Clinic of Faculty of Medicine of Comenius University and Bratislava University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 4, 2014

First Posted

February 5, 2014

Study Start

March 1, 2013

Primary Completion

May 1, 2013

Study Completion

July 1, 2013

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations