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

• Sponsor: Emory University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00873613
• Collaborator: (none)
• Enrollment: 705
• Location: 1
• Arms: 2
• Duration (Months): 39
• Patients Per Site Per Month: 18.1

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Headache; Acute, Focal Neurologic Disease; Severely Elevated Blood Pressure; Acute Visual Loss	Procedure: Use of Non-dilated retinal photography	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 705 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Screening
• Official Title: Digital Ocular Fundus Photography in the Emergency Department: A New Application for Telemedicine?
• Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: Aug 1, 2011
• Actual Study Completion Date: Jul 1, 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Difference in detection rate of papilledema by emergency department physicians using non-dilated retinal photography vs. direct ophthalmoscopy. [6-12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Emory University	Atlanta	Georgia	United States	30322

Sponsors and Collaborators

• Emory University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Beau Bruce, MD, Assistant Professor, Emory University
• ClinicalTrials.gov Identifier: NCT00873613
• Other Study ID Numbers: IRB00006900
• First Posted: Apr 1, 2009
• Last Update Posted: Nov 8, 2013
• Last Verified: Nov 1, 2013

• Additional relevant MeSH terms: Nervous System Diseases; Hypertension; Emergencies; Headache

Study Results

No Results Posted as of Nov 8, 2013