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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00759044
First Posted: September 25, 2008
Last Update Posted: October 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image
  Purpose
To validate a new methodology, named Retinal Leakage Analysis (RLA), for mapping the human Blood-Retinal Barrier (BRB) function, in the clinical practice.

Condition
Age-Related Maculopathy Diabetic Macular Edema

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of a New Methodology for Mapping the Human Blood-Retinal Barrier Function

Further study details as provided by Association for Innovation and Biomedical Research on Light and Image:

Primary Outcome Measures:
  • Blood-Retinal Barrier (BRB) function measured by Retinal Leakage Analysis (RLA).

Enrollment: 90
Study Start Date: March 2008
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
AMD
Patients diagnosed with AMD
DME
Patients diagnosed with DME

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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).
Criteria

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
  Contacts and Locations
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): NCT00759044


Locations
Portugal
AIBILI Clinical Trial Center
Coimbra, Portugal, 3000-548
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier: NCT00759044     History of Changes
Other Study ID Numbers: CNTM023A
First Submitted: September 24, 2008
First Posted: September 25, 2008
Last Update Posted: October 15, 2015
Last Verified: October 2015

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