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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Association for Innovation and Biomedical Research on Light and Image.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier:
NCT00797524
First received: November 24, 2008
Last updated: October 13, 2010
Last verified: October 2010
History of Changes

November 24, 2008
October 13, 2010
November 2008
Not Provided
Retinal leakage and retinal thickness. [ Time Frame: After the visit ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00797524 on ClinicalTrials.gov Archive Site
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Function and Structure Imaging in Different Retinal Diseases: Retinal Leakage Analyzer Versus Optical Coherence Tomography
Function and Structure Imaging in Different Retinal Diseases. Retinal Leakage Analyzer vs. Optical Coherence Tomography.

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.
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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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.
  • Diabetic Retinopathy
  • Age-Related Macular Degeneration
  • Macular Edema
Not Provided
  • DR
    Diabetic Retinopathy
  • ARMD
    Age-Related Macular Degeneration
  • ME
    Macular Edema
Bernardes R, Maduro C, Serranho P, Araújo A, Barbeiro S, Cunha-Vaz J. Improved adaptive complex diffusion despeckling filter. Opt Express. 2010 Nov 8;18(23):24048-59.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
60
December 2011
Not Provided

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Portugal
 
NCT00797524
023RLAOCT
No
José Cunha-Vaz, MD, PhD, AIBILI
Association for Innovation and Biomedical Research on Light and Image
Not Provided
Principal Investigator: José Cunha-Vaz, MD, PhD Association for Innovation and Biomedical Research on Light and Image
Association for Innovation and Biomedical Research on Light and Image
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP