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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00797524

Enrollment

Registered

2008-11-25

Start date

2008-11-30

Completion date

2010-10-31

Last updated

2015-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration, Diabetic Retinopathy, Macular Edema

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Retinal leakage and retinal thickness.	After the visit

Countries

Portugal

Outcome results