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

Completed

• Conditions: Diabetic Retinopathy; Age-Related Macular Degeneration; Macular Edema

• Registration Number: NCT00797524
• Lead Sponsor: Association for Innovation and Biomedical Research on Light and Image

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2008-11-24
• Study First Submitted QC: 2008-11-24
• Study First Posted: 2008-11-25
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Retinal leakage and retinal thickness.	After the visit

Trial Locations

Locations (1)

AIBILI; 🇵🇹 Coimbra, Portugal