Digital Ocular Fundus Photography in the Emergency Department: A New Application for Telemedicine?

November 7, 2013 updated by: Beau Bruce, MD, Emory University
The purpose of this study is to determine if non-dilated retinal photography in the emergency room improves the diagnosis of papilledema (optic nerve swelling) in patients with neurologic disease compared to direct ophthalmoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

705

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Presenting complaint of headache, acute focal neurologic disease, or acute visual changes
  • Diastolic blood pressure >= 120
  • Age 18 or older

Exclusion Criteria:

  • Unable to sit-up, not interested in participation, confused
  • Age 17 or younger

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

  • Primary Purpose: SCREENING
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Direct ophthalmoscopy
EXPERIMENTAL: Non-dilated retinal photography
Procedure: Use of Non-dilated retinal photography
Kowa Non-Myd alpha-D Non-dilated fundus camera will be used to obtain photographs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference in detection rate of papilledema by emergency department physicians using non-dilated retinal photography vs. direct ophthalmoscopy.
Time Frame: 6-12 months
6-12 months

Collaborators and Investigators

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

Sponsor

Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2009

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

July 1, 2012

Study Registration Dates

First Submitted

March 31, 2009

First Submitted That Met QC Criteria

March 31, 2009

First Posted (ESTIMATE)

April 1, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 8, 2013

Last Update Submitted That Met QC Criteria

November 7, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00006900

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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