Headache Clinical Trial
Official title:
Digital Ocular Fundus Photography in the Emergency Department: A New Application for Telemedicine?
Verified date | November 2013 |
Source | Emory University |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 705 |
Est. completion date | July 2012 |
Est. primary completion date | August 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening
Country | Name | City | State |
---|---|---|---|
United States | Emory University | Atlanta | Georgia |
Lead Sponsor | Collaborator |
---|---|
Emory University |
United States,
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.1553-2712.201 — View 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. — View 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 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Difference in detection rate of papilledema by emergency department physicians using non-dilated retinal photography vs. direct ophthalmoscopy. | 6-12 months | Yes |
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