Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00873613
Other study ID # IRB00006900
Secondary ID
Status Completed
Phase N/A
First received March 31, 2009
Last updated November 7, 2013
Start date April 2009
Est. completion date July 2012

Study information

Verified date November 2013
Source Emory University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening


Intervention

Procedure:
Use of Non-dilated retinal photography
Kowa Non-Myd alpha-D Non-dilated fundus camera will be used to obtain photographs.

Locations

Country Name City State
United States Emory University Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Emory University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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

Outcome

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
See also
  Status Clinical Trial Phase
Withdrawn NCT03472872 - A Comparative Efficacy Trial of IV Acetaminophen Versus IV Ketorolac for Emergency Department Treatment of Generalized Headache Phase 4
Withdrawn NCT05410366 - Safe Harbors in Emergency Medicine, Specific Aim 3
Withdrawn NCT02866084 - Neuromodulation Treatment of Vestibular Migraines N/A
Active, not recruiting NCT03537573 - Provider-Targeted Behavioral Interventions to Prevent Unsafe Opioid Prescribing for Acute Pain in Primary Care N/A
Recruiting NCT05891808 - miR-155 Expression in Episodic and Chronic Migraine
Not yet recruiting NCT04352218 - Safety Profile of PETALO CVS in the Treatment of Non-thrombotic Internal Jugular Vein Stenosis and Chronic Headache Phase 2
Completed NCT02734992 - Acceptance and Commitment Therapy vs Medical Treatment as Usual Wait-list Control for Primary Headache Sufferers N/A
Completed NCT01153789 - Study of Oculomotor Dysfunction Leading to Children Vertigo N/A
Completed NCT01327118 - Prostaglandin F2alpha in a Human Headache Model N/A
Not yet recruiting NCT00969995 - Identification of Inflammatory Markers in Migraine Patients N/A
Not yet recruiting NCT00752921 - Randomized Placebo Controlled Trial With Etoricoxib That is Taken to Prevent the Yom Kippur Headache Phase 4
Terminated NCT00291395 - PGI2 Induced Headache and Cerebral Haemodynamics in Healthy Volunteers Phase 1
Completed NCT00212810 - Evaluation of the Effectiveness of Topiramate in Preventing the Transformation From Episodic Migraine to Chronic Daily Headache. Phase 4
Completed NCT00263094 - An End to the Yom Kippur (and Ramadan) Headache N/A
Completed NCT00135122 - Prednisolone in the Treatment of Withdrawal Headache in Probable Medication Overuse Headache Phase 3
Completed NCT02475005 - An Intervention to Improve Adolescent Headache Self-management N/A
Completed NCT03163901 - The Effect of OMT on Functional Outcomes and Anti-inflammatory Biomarkers in Mild to Moderate Traumatic Brain Injury N/A
Completed NCT01664585 - Exercise Training With Physically Active Lifestyle to Reduce Headache and Quality of Life N/A
Completed NCT04632420 - Evaluation of Headache and Childbirth in a Chronic Pain Population
Recruiting NCT05033613 - Home Blood Pressure Monitoring Before and After COVID-19 Vaccination in Patients at High Risk of Cardiovascular Disease