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

Primary Purpose

Headache, Acute, Focal Neurologic Disease, Severely Elevated Blood Pressure

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Use of Non-dilated retinal photography

Sponsored by

Emory University

About this trial

This is an interventional screening trial for Headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Emory University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Direct ophthalmoscopy

Non-dilated retinal photography

Arm Description

Outcomes

Primary Outcome Measures

Difference in detection rate of papilledema by emergency department physicians using non-dilated retinal photography vs. direct ophthalmoscopy.

Secondary Outcome Measures

Full Information

NCT ID

First Posted

March 31, 2009

Last Updated

November 7, 2013

Sponsor

Emory University

1. Study Identification

Unique Protocol Identification Number

NCT00873613

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2013

Overall Recruitment Status

Completed

Study Start Date

April 2009 (undefined)

Primary Completion Date

August 2011 (Actual)

Study Completion Date

July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Emory University

4. Oversight

Data Monitoring Committee

No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Headache, Acute, Focal Neurologic Disease, Severely Elevated Blood Pressure, Acute Visual Loss

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Non-Randomized

Enrollment

705 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Direct ophthalmoscopy

Arm Type

No Intervention

Arm Title

Non-dilated retinal photography

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Use of Non-dilated retinal photography

Intervention Description

Kowa Non-Myd alpha-D Non-dilated fundus camera will be used to obtain photographs.

Primary Outcome Measure Information:

Title

Difference in detection rate of papilledema by emergency department physicians using non-dilated retinal photography vs. direct ophthalmoscopy.

Time Frame

6-12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Facility Information:

Facility Name

Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21268749

Citation

Bruce BB, Lamirel C, Wright DW, Ward A, Heilpern KL, Biousse V, Newman NJ. Nonmydriatic ocular fundus photography in the emergency department. N Engl J Med. 2011 Jan 27;364(4):387-9. doi: 10.1056/NEJMc1009733. No abstract available.

Results Reference

result

PubMed Identifier

21906202

Citation

Bruce BB, Lamirel C, Biousse V, Ward A, Heilpern KL, Newman NJ, Wright DW. Feasibility of nonmydriatic ocular fundus photography in the emergency department: Phase I of the FOTO-ED study. Acad Emerg Med. 2011 Sep;18(9):928-33. doi: 10.1111/j.1553-2712.2011.01147.x.

Results Reference

result

PubMed Identifier

23433654

Citation

Bruce BB, Thulasi P, Fraser CL, Keadey MT, Ward A, Heilpern KL, Wright DW, Newman NJ, Biousse V. Diagnostic accuracy and use of nonmydriatic ocular fundus photography by emergency physicians: phase II of the FOTO-ED study. Ann Emerg Med. 2013 Jul;62(1):28-33.e1. doi: 10.1016/j.annemergmed.2013.01.010. Epub 2013 Feb 21.

Results Reference

result

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

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