Validation of a New Methodology for Mapping the Human Blood-Retinal Barrier Function

October 13, 2015 updated by: Association for Innovation and Biomedical Research on Light and Image
To validate a new methodology, named Retinal Leakage Analysis (RLA), for mapping the human Blood-Retinal Barrier (BRB) function, in the clinical practice.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

90

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 Clinical Trial Center

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with AMD or DME followed regularly by their ophthalmologist at the AIBILI Clinical Trial Center will be asked to perform additional optical examinations as a continuation of the routine fluorescein angiographies (FA).

Description

Inclusion Criteria:

  • Patients diagnosed with AMD, or
  • Patients diagnosed with DME
  • Age over 18 years
  • Inform consent

Exclusion Criteria:

  • Cataract or other eye disease that may interfere with fundus examinations
  • Glaucoma
  • Dilatation of the pupil < 5 mm

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

Cohorts and Interventions

Group / Cohort
AMD
Patients diagnosed with AMD
DME
Patients diagnosed with DME

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Blood-Retinal Barrier (BRB) function measured by Retinal Leakage Analysis (RLA).

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: José G Cunha-Vaz, Prof., Association for Innovation and Biomedical Research on Light and Image

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

March 1, 2008

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

September 24, 2008

First Submitted That Met QC Criteria

September 24, 2008

First Posted (Estimate)

September 25, 2008

Study Record Updates

Last Update Posted (Estimate)

October 15, 2015

Last Update Submitted That Met QC Criteria

October 13, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CNTM023A

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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