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Function and Structure Imaging in Different Retinal Diseases: Retinal Leakage Analyzer Versus Optical Coherence Tomography

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ClinicalTrials.gov Identifier: NCT00797524
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

The main objective of this observational study is to characterize and correlate functional and structural changes at the retinal level using the Retinal Leakage Analyzer (RLA) and the Optical Coherence Tomograph (OCT).

To show if it is possible to use OCT as an indirect measurement of leakage, this study will check, in a primary analysis, for OCT changes between fluorescein leaking and non-leaking areas (identified by Retinal Leakage Analyzer).

As a secondary objective, changes in RLA and OCT over time (between two consecutive visits) will be analyzed and characterized.

The results of this study will be used exclusively for scientific purposes.


Condition or disease
Diabetic Retinopathy Age-Related Macular Degeneration Macular Edema

Study Design

Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Function and Structure Imaging in Different Retinal Diseases. Retinal Leakage Analyzer vs. Optical Coherence Tomography.
Study Start Date : November 2008
Primary Completion Date : October 2010
Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
DR
Diabetic Retinopathy
ARMD
Age-Related Macular Degeneration
ME
Macular Edema


Outcome Measures

Primary Outcome Measures :
  1. Retinal leakage and retinal thickness. [ Time Frame: After the visit ]

Eligibility Criteria

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
Subjects followed regularly by their ophthalmologist at the AIBILI Clinical Trial Center (Azinhaga de Santa Comba - Celas, Coimbra, Portugal), performing, as part of their follow-up, fluorescein angiography with the Heidelberg Retina Angiograph (HRA) and optical coherence tomography with OCT, and fulfilling the inclusion/exclusion criteria will be included.
Criteria

Inclusion Criteria:

  • Diagnosis of DR, ARMD or ME
  • Females or Males
  • Age over 18 years
  • Signed Informed Consent Form

Exclusion Criteria:

  • Cataract or other eye disease that may interfere with fundus examinations
  • Vitreous syneresis or posterior vitreous detachment
  • 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): NCT00797524


Locations
Portugal
AIBILI
Coimbra, Portugal, 3000-548
Sponsors and Collaborators
Association for Innovation and Biomedical Research on Light and Image
Investigators
Principal Investigator: José Cunha-Vaz, MD, PhD Association for Innovation and Biomedical Research on Light and Image
More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier: NCT00797524     History of Changes
Other Study ID Numbers: 023RLAOCT
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Macular Degeneration
Macular Edema
Diabetic Retinopathy
Retinal Diseases
Retinal Degeneration
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases