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

December 4, 2017 updated by: Johns Hopkins University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Normal, non-diabetic patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • No macular pathology
  • No Diabetes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1: Non Diabetic
Normal retina
Other: OCT Imaging both Normal and diabetic groups
Images taken to determine thickness values in the retina
Other Names:
  • Ocular Coherence tomography
Group 2: Diabetes with no retinopathy
Diabetic patients without diabetic retinopathy
Other: OCT Imaging both Normal and diabetic groups
Images taken to determine thickness values in the retina
Other Names:
  • Ocular Coherence tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Normative retinal thickness data for comparison
Time Frame: one year
Normative retinal thickness data for comparison
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 17, 2013

First Submitted That Met QC Criteria

September 19, 2013

First Posted (Estimate)

September 20, 2013

Study Record Updates

Last Update Posted (Actual)

December 6, 2017

Last Update Submitted That Met QC Criteria

December 4, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 03-11-05-03

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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