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

NCT ID: NCT00873613

Last Updated: 2013-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

705 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2012-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Direct ophthalmoscopy

Group Type NO_INTERVENTION

No interventions assigned to this group

Non-dilated retinal photography

Group Type EXPERIMENTAL

Use of Non-dilated retinal photography

Intervention Type PROCEDURE

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

Interventions

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Use of Non-dilated retinal photography

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Emory University

OTHER

Sponsor Role lead

Responsible Party

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Beau Bruce, MD

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Emory University

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 21268749 (View on PubMed)

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.

Reference Type RESULT
PMID: 21906202 (View on PubMed)

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.

Reference Type RESULT
PMID: 23433654 (View on PubMed)

Other Identifiers

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IRB00006900

Identifier Type: -

Identifier Source: org_study_id