Mobile Clinic - a Cross-sectional Epidemiological Survey | NCT02055612

Studies
Mobile Clinic - a Cross-sectional Epidemiological Survey

NCT02055612

Sponsor

Novartis Slovakia, s.r.o.

Status

Completed

Last Update Posted

Mar 1, 2017Actual

Enrollment

3,278Actual

Phase

Not provided

Conditions

Age Related Macular Degeneration

Interventions

Not provided

Countries

Slovakia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

May 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Feb 4, 2014

First Submission Date that Met QC Criteria

Feb 4, 2014

First Posted Date

Feb 5, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 28, 2017

Last Update Posted Date

Mar 1, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,278Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vladimir Krasnik, M.D., PhD.	Ophthalmology Clinic of Faculty of Medicine of Comenius University and Bratislava University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Slovakia, s.r.o.		Bratislava		821 04	Slovakia

Condition Browse Module

MeSH Terms

ID	Term
D008268	Macular Degeneration

Ancestor Terms

ID	Term
D012162	Retinal Degeneration
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided