Five-year Incidence of Age-related Macular Degeneration in the Central Region of Portugal (AMDIncidencePT)

November 7, 2017 updated by: Association for Innovation and Biomedical Research on Light and Image
To assess the five-year incidence of AMD in a population from the central region of Portugal, previously phenotypically characterized.

Study Overview

Status

Completed

Conditions

Detailed Description

Subjects who participated in the Epidemiologic Coimbra Eye Study (NCT01298674) between 2009 and 2013 will attend a single visit, after giving informed consent.

Study Type

Observational

Enrollment (Actual)

5996

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

  • Portugal
      • Coimbra, Portugal, 3000-548
        • AIBILI/CEC - Centro Ensaios Clínicos

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will consist of male and female subjects who have participated and phenotyped in the Epidemiologic Coimbra Eye Study (NTC01298674).

It is expected to recruit up to a total of 5.996 subjects, that is up to 2.975 subjects from the Mira Healthcare Unit and up to 3.021 subjects from the Lousã Healthcare Unit.

Description

Inclusion Criteria:

  • Subjects who participated in the Epidemiologic Coimbra Eye Study (NCT01298674) and that were phenotyped;
  • Subjects capable of understanding the information about the study and to give their informed consent to enter the study;
  • Subjects willing and able to comply with the study procedures.

Exclusion Criteria:

- Not applicable

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
Phenotypic classification of AMD in the five-year clinical visit. Comparison of this classification with the grading of 5 years ago.
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Risk factors: Demographic, Medical history, Ophthalmologic history, Family history of AMD, Systemic comorbidities and medication, Nutritional and Lifestyle habits. Signs of AMD on the multimodal evaluation.
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association for Innovation and Biomedical Research on Light and Image

Investigators

  • Principal Investigator: Rufino Silva, PhD, Association for Innovation and Biomedical Research on Light and Image

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

July 1, 2016

Primary Completion (Actual)

September 18, 2017

Study Completion (Actual)

October 31, 2017

Study Registration Dates

First Submitted

April 20, 2016

First Submitted That Met QC Criteria

April 20, 2016

First Posted (Estimate)

April 22, 2016

Study Record Updates

Last Update Posted (Actual)

November 9, 2017

Last Update Submitted That Met QC Criteria

November 7, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4C-2016-09
  • AMDIncidence-CPT (Other Identifier: 4C-2016-09)

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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