NCT01946997

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2006

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 17, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
Last Updated

December 6, 2017

Status Verified

December 1, 2017

Enrollment Period

3.3 years

First QC Date

September 17, 2013

Last Update Submit

December 4, 2017

Conditions

Diabetic Retinopathy

Outcome Measures

Primary Outcomes (1)

  • Normative retinal thickness data for comparison

    Normative retinal thickness data for comparison

    one year

Study Arms (2)

Group 1: Non Diabetic

Normal retina

Other: OCT Imaging both Normal and diabetic groups

Group 2: Diabetes with no retinopathy

Diabetic patients without diabetic retinopathy

Other: OCT Imaging both Normal and diabetic groups

Interventions

OCT Imaging both Normal and diabetic groupsOTHER

Images taken to determine thickness values in the retina

Also known as: Ocular Coherence tomography
Group 1: Non DiabeticGroup 2: Diabetes with no retinopathy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Normal, non-diabetic patients

You may qualify if:

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

You may not qualify if:

  • No macular pathology
  • No Diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetic Retinopathy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesDiabetic AngiopathiesVascular DiseasesCardiovascular DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Quan D Nguyen, MD, MSc

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 17, 2013

First Posted

September 20, 2013

Study Start

July 1, 2006

Primary Completion

November 1, 2009

Study Completion

December 1, 2010

Last Updated

December 6, 2017

Record last verified: 2017-12