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

This study has been completed.

First Received on September 24, 2008. Last Updated on October 13, 2010 History of Changes

Sponsor:	Association for Innovation and Biomedical Research on Light and Image
Information provided by:	Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier:	NCT00759044

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

Resource links provided by NLM:

Genetics Home Reference related topics: age-related macular degeneration X-linked juvenile retinoschisis

MedlinePlus related topics: Edema

U.S. FDA Resources

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). [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	March 2008
Study Completion Date:	October 2010

Groups/Cohorts
AMD Patients diagnosed with AMD
DME Patients diagnosed with DME

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Bernardes R, Dias J, Cunha-Vaz J. Mapping the human blood-retinal barrier function. IEEE Trans Biomed Eng. 2005 Jan;52(1):106-16.

Responsible Party:	Prof. José G Cunha-Vaz, AIBILI
ClinicalTrials.gov Identifier:	NCT00759044 History of Changes
Other Study ID Numbers:	CNTM023A
Study First Received:	September 24, 2008
Last Updated:	October 13, 2010
Health Authority:	Portugal: AIBILI-Comissão de Ética para a Saúde

Additional relevant MeSH terms:

Edema
Macular Edema
Macular Degeneration
Signs and Symptoms

Retinal Degeneration
Retinal Diseases
Eye Diseases

ClinicalTrials.gov processed this record on February 09, 2012