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

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ClinicalTrials.gov Identifier: NCT02748824
Recruitment Status : Completed
First Posted : April 22, 2016
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image

Brief Summary:
To assess the five-year incidence of AMD in a population from the central region of Portugal, previously phenotypically characterized.

Condition or disease
Age-Related Macular Degeneration

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
Actual Enrollment : 5996 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Five-year Incidence of Age-related Macular Degeneration in the Central Region of Portugal
Study Start Date : July 2016
Actual Primary Completion Date : September 18, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02748824


Locations
Portugal
AIBILI/CEC - Centro Ensaios Clínicos
Coimbra, Portugal, 3000-548
Sponsors and Collaborators
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

Responsible Party: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier: NCT02748824     History of Changes
Other Study ID Numbers: 4C-2016-09
AMDIncidence-CPT ( Other Identifier: 4C-2016-09 )
First Posted: April 22, 2016    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017

Keywords provided by Association for Innovation and Biomedical Research on Light and Image:
Age- Related Macular Degeneration; Diabetic Retinopathy; Glaucoma; Cataract

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases