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

Completed

• Conditions: Diabetic Retinopathy
• Interventions: Other: OCT Imaging both Normal and diabetic groups

• Registration Number: NCT01946997
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

Not available

Study Timeline

• Study Start: 2006-07
• Primary Completion: 2009-11
• Study Completion: 2010-12
• Study First Submitted: 2013-09-17
• Study First Submitted QC: 2013-09-19
• Study First Posted: 2013-09-20
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-04
• Last Update Posted: 2017-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

• No macular pathology
• No Diabetes

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2: Diabetes with no retinopathy	OCT Imaging both Normal and diabetic groups	Diabetic patients without diabetic retinopathy
Group 1: Non Diabetic	OCT Imaging both Normal and diabetic groups	Normal retina

Primary Outcome Measures

Name	Time	Method
Normative retinal thickness data for comparison	one year	Normative retinal thickness data for comparison