Retinal Thickness Analysis Using Optical Coherence Tomography

This study is currently recruiting participants.

Verified by Association for Innovation and Biomedical Research on Light and Image, November 2008

Sponsored by:	Association for Innovation and Biomedical Research on Light and Image
Information provided by:	Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier:	NCT00797134

Purpose

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.

Condition
Diabetic Retinopathy

MedlinePlus related topics: Diabetic Eye Problems Retinal Disorders

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort
Official Title:	Retinal Thickness Analysis Using Optical Coherence Tomography

Further study details as provided by Association for Innovation and Biomedical Research on Light and Image:

Primary Outcome Measures:

Retinal thickness. [ Time Frame: After visit(s) ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	45
Study Start Date:	November 2008
Estimated Study Completion Date:	November 2010

Groups/Cohorts
DR Diabetic Retinopathy

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Subjects followed regularly by their ophthalmologist at the AIBILI Clinical Trial Center (Azinhaga de Santa Comba - Celas, Coimbra, Portugal), performing, as part of their follow-up, optical coherence tomography with OCT, and fulfilling the inclusion/exclusion criteria will be included.

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797134

Contacts

Contact: AIBILI CEC		aibili@aibili.pt
Contact: AIBILI CNTM		seccntm@aibili.pt

Locations

Portugal
AIBILI	Recruiting
Coimbra, Portugal, 3000-548
Contact: AIBILI CEC aibili@aibili.pt
Contact: AIBILI CNTM seccntm@aibili.pt
Principal Investigator: José Cunha-Vaz, MD, PhD
Sub-Investigator: Rui Bernardes, PhD

Sponsors and Collaborators

Association for Innovation and Biomedical Research on Light and Image

Investigators

Principal Investigator:

José Cunha-Vaz, MD, PhD

Association for Innovation and Biomedical Research on Light and Image

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	AIBILI ( José Cunha-Vaz, MD, PhD )
Study ID Numbers:	CNTM025AOCT
Study First Received:	November 24, 2008
Last Updated:	November 27, 2008
ClinicalTrials.gov Identifier:	NCT00797134
Health Authority:	Portugal: Health Ethic Committee

Study placed in the following topic categories:

Diabetic Retinopathy
Eye Diseases
Diabetes Mellitus
Vascular Diseases
Endocrine System Diseases

Endocrinopathy
Diabetes Complications
Retinal Diseases
Diabetic Angiopathies

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 15, 2009