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

Association for Innovation and Biomedical Research on Light and Image

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT00797524

023RLAOCT

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

35 participants in 3 patient groups

DR

Description:

Diabetic Retinopathy

ARMD

Description:

Age-Related Macular Degeneration

ME

Description:

Macular Edema