NCT02748824

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
5,996

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2016

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

April 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2017

Completed
Last Updated

November 9, 2017

Status Verified

November 1, 2017

Enrollment Period

1.2 years

First QC Date

April 20, 2016

Last Update Submit

November 7, 2017

Conditions

Keywords

Age- Related Macular Degeneration; Diabetic Retinopathy; Glaucoma; Cataract

Outcome Measures

Primary Outcomes (1)

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

    5 years

Secondary Outcomes (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.

    5 years

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • \- Not applicable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

AIBILI/CEC - Centro Ensaios Clínicos

Coimbra, 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 DegenerationDiabetic RetinopathyGlaucomaCataract

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System DiseasesOcular HypertensionLens Diseases

Study Officials

  • Rufino Silva, PhD

    Association for Innovation and Biomedical Research on Light and Image

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 20, 2016

First Posted

April 22, 2016

Study Start

July 1, 2016

Primary Completion

September 18, 2017

Study Completion

October 31, 2017

Last Updated

November 9, 2017

Record last verified: 2017-11

Locations