NCT01715870

Brief Summary

The study population will be selected from the "Epidemiological study on the prevalence of Age related Macular Degeneration in Portugal" (Protocol N. CC-01-2009) where retinal photographic grading (current gold standard for AMD assessment) was performed to confirm AMD diagnostic. This study provides a population-based sample in which precise and contemporary information on the frequency of nutritional and lifestyle risk factors will be collected, enabling to evaluate whether the separate and/or joint effects of these factors, if found significant, are likely to have a major public health impact in terms of AMD.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2012

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

First Submitted

Initial submission to the registry

October 23, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
Last Updated

October 9, 2015

Status Verified

October 1, 2015

Enrollment Period

1.3 years

First QC Date

October 23, 2012

Last Update Submit

October 7, 2015

Conditions

Keywords

Age related macular degenerationFood habitsLife styleRisk factorsquestionnaire

Outcome Measures

Primary Outcomes (1)

  • Life style and food habits questionnaire.

    Life style and food habits questionnaire. (This questionnaire assesses life style habits such as physical exercise and smoking habits and quantifies dietary intake.)

    2 years

Study Arms (1)

Population of the "Epidemiological study on AMD".

Behavioral: Life style and food habits questionnaire

Interventions

Population of the "Epidemiological study on AMD".

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subjects that participated in the "Epidemiological study on the prevalence of Age related Macular Degeneration in Portugal" (Protocol N. CC-01-2009) will be invited to answer a validated life style and food habits questionnaire.

You may qualify if:

  • Subjects included in the Epidemiologic Study (Protocol N. CC-01-2009). (Subjects aged over 55 years-old included in health care units of Mira or Lousã).
  • Written Informed Consent Form signed.

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIBILI

Coimbra, Coimbra District, 3000-548, Portugal

Location

Related Publications (1)

  • Barreto P, Farinha C, Coimbra R, Cachulo ML, Melo JB, Lechanteur Y, Hoyng CB, Cunha-Vaz J, Silva R. Interaction between genetics and the adherence to the Mediterranean diet: the risk for age-related macular degeneration. Coimbra Eye Study Report 8. Eye Vis (Lond). 2023 Aug 14;10(1):38. doi: 10.1186/s40662-023-00355-0.

MeSH Terms

Conditions

Macular DegenerationFeeding Behavior

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesBehavior, AnimalBehavior

Study Officials

  • Rufino M Silva, MD, PhD

    Association for Innovation and Biomedical Research on Light and Image

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 23, 2012

First Posted

October 29, 2012

Study Start

December 1, 2012

Primary Completion

April 1, 2014

Study Completion

April 1, 2014

Last Updated

October 9, 2015

Record last verified: 2015-10

Locations