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Clinical Trials/NCT00797524
NCT00797524
Completed
Not Applicable

Function and Structure Imaging in Different Retinal Diseases. Retinal Leakage Analyzer vs. Optical Coherence Tomography.

Association for Innovation and Biomedical Research on Light and Image1 site in 1 country35 target enrollmentNovember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Retinopathy
Sponsor
Association for Innovation and Biomedical Research on Light and Image
Enrollment
35
Locations
1
Primary Endpoint
Retinal leakage and retinal thickness.
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 2008
End Date
October 2010
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Association for Innovation and Biomedical Research on Light and Image
Responsible Party
Sponsor

Eligibility 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

Outcomes

Primary Outcomes

Retinal leakage and retinal thickness.

Time Frame: After the visit

Study Sites (1)

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