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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Beau Bruce, MD, Emory University
ClinicalTrials.gov Identifier:
NCT00873613
First received: March 31, 2009
Last updated: March 27, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention
Headache
Acute, Focal Neurologic Disease
Severely Elevated Blood Pressure
Acute Visual Loss
 Procedure: Use of Non-dilated retinal photography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Screening
Official Title: Digital Ocular Fundus Photography in the Emergency Department: A New Application for Telemedicine?

Resource links provided by NLM:

MedlinePlus related topics: Headache
U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:
  • Difference in detection rate of papilledema by emergency department physicians using non-dilated retinal photography vs. direct ophthalmoscopy. [ Time Frame: 6-12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 3000
Study Start Date: April 2009
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00873613

Locations
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Emory University
  More Information

No publications provided

Responsible Party: Beau Bruce, MD, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT00873613     History of Changes
Other Study ID Numbers: EMORY-IRB00006900
Study First Received: March 31, 2009
Last Updated: March 27, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Emergencies
Headache
Vision, Low
Disease Attributes
Pathologic Processes
Pain
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Vision Disorders
Sensation Disorders
Eye Diseases

ClinicalTrials.gov processed this record on May 16, 2013