Retinal Thickness Analysis Using Optical Coherence Tomography

Completed

• Conditions: Diabetic Retinopathy

• Registration Number: NCT00797134
• Lead Sponsor: Association for Innovation and Biomedical Research on Light and Image

Brief Summary

The main objective of this study is to characterize and correlate diabetic macular edema (DME), i.e. increased retinal thickness, measured by Optical Coherence Tomograph (OCT), and retinal visual function.

The secondary objectives of this study are the analysis and characterization of DME progression over time (between two visits), and the comparison of OCT data obtained with different devices.

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: 2010-07
• Study Completion: 2010-07
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• Diagnosis of DR
• 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 thickness.	After visit(s)

Secondary Outcome Measures

Name	Time	Method
Choroidal Thickness	After visit(s)

Trial Locations

Locations (1)

AIBILI; 🇵🇹 Coimbra, Portugal