- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02748824
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
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Coimbra, Portugal, 3000-548
- AIBILI/CEC - Centro Ensaios Clínicos
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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
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5 years
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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.
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
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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