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NCT00797134 Clinical Trial

Retinal Thickness Analysis Using Optical Coherence Tomography

Diabetic Retinopathy Clinical Trial

Official title:
Retinal Thickness Analysis Using Optical Coherence Tomography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00797134
Other study ID # CNTM025AOCT
Secondary ID
Status Completed
Phase N/A
First received November 24, 2008
Last updated February 2, 2015
Start date November 2008
Est. completion date July 2010

Study information
Verified date February 2015
Source Association for Innovation and Biomedical Research on Light and Image
Contact n/a
Is FDA regulated No
Health authority Portugal: Health Ethic Committee
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 45
Est. completion date July 2010
Est. primary completion date July 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Observational Model: Cohort

Related Conditions & MeSH terms

Locations
Country Name City State
Portugal AIBILI Coimbra

Sponsors (1)
Lead Sponsor Collaborator
Association for Innovation and Biomedical Research on Light and Image

Country where clinical trial is conducted

Portugal, 

Outcome
Type Measure Description Time frame Safety issue
Primary Retinal thickness. After visit(s) No
Secondary Choroidal Thickness After visit(s) No
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