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Evaluation of the Retina of Subjects Without Diabetes Mellitus and Subjects With Diabetes Mellitus Without Diabetic Retinopathy Using Optical Coherence Tomography

NCT ID: NCT01946997

Last Updated: 2017-12-06

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

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-12-31

Brief Summary

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The purpose of this study is to evaluate topographic features of the posterior pole of the eye in normal subjects as well as in subjects with diabetes mellitus but without diabetic retinopathy (DR) using optical coherence tomography (OCT). The investigators proposal is a novel study to determine retinal volume of normal and diabetic subjects without DR. Specifically, the investigators will establish a standardized reference range for retinal thickness and volume that will provide standards for OCT analysis of different clinical trials for retinal diseases.

Detailed Description

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Conditions

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Diabetic Retinopathy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1: Non Diabetic

Normal retina

OCT Imaging both Normal and diabetic groups

Intervention Type OTHER

Images taken to determine thickness values in the retina

Group 2: Diabetes with no retinopathy

Diabetic patients without diabetic retinopathy

OCT Imaging both Normal and diabetic groups

Intervention Type OTHER

Images taken to determine thickness values in the retina

Interventions

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OCT Imaging both Normal and diabetic groups

Images taken to determine thickness values in the retina

Intervention Type OTHER

Other Intervention Names

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Ocular Coherence tomography

Eligibility Criteria

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Inclusion Criteria

* Healthy retinas
* Willingness to sign informed consent to have OCT images taken.

Exclusion Criteria

* No macular pathology
* No Diabetes
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Quan D Nguyen, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Other Identifiers

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03-11-05-03

Identifier Type: -

Identifier Source: org_study_id