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

Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946997
• Other study ID #: 03-11-05-03
• Status: Completed
• Phase: N/A
• First received: September 17, 2013
• Last updated: December 4, 2017
• Start date: July 2006
• Est. completion date: December 2010

Study information

• Verified date: December 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: December 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Healthy retinas

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

Exclusion Criteria:

• No macular pathology

• No Diabetes

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetic Retinopathy
• Retinal Diseases

Intervention

Other:
• OCT Imaging both Normal and diabetic groups
Images taken to determine thickness values in the retina

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Normative retinal thickness data for comparison	Normative retinal thickness data for comparison	one year