Retinal Thickness Analysis Using Optical Coherence Tomography

NCT ID: NCT00797134

Last Updated: 2015-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2010-07-31

Brief Summary

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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

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Conditions

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Diabetic Retinopathy

Study Design

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Observational Model Type

COHORT

Study Groups

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DR

Diabetic Retinopathy

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Association for Innovation and Biomedical Research on Light and Image

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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José Cunha-Vaz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Association for Innovation and Biomedical Research on Light and Image

Locations

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AIBILI

Coimbra, Coimbra District, Portugal

Site Status

Countries

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Portugal

Related Links

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Other Identifiers

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CNTM025AOCT

Identifier Type: -

Identifier Source: org_study_id

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