Overview

This trial is active, not recruiting.

Conditions head injury, traumatic brain injury (tbi), photosensitivity, photophobia
Sponsor Ohio State University
Collaborator U.S. Army Medical Research and Materiel Command
Start date August 2013
End date December 2014
Trial size 80 participants
Trial identifier NCT01942564, 2013H0151, W81XWH-12-1-0434

Summary

After a head injury, many people find that exposure to light causes them increased discomfort. By measuring how the pupil in the eye constricts to flashes of red and blue light, this study will investigate whether this phenomenon is due to a change in the eye's sensitivity to light.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional
Arm
Age 18 years or older Had a head injury that occurred at least 6 months prior to entering study Have found lights more bothersome since injury
Age 18 years or older Have not had a previous head injury Have had a full eye examination at Ohio State University College of Optometry during last 6 months.

Primary Outcomes

Measure
Pupil Responses
time frame: 2 weeks

Secondary Outcomes

Measure
Sleep Rhythms
time frame: 2 weeks
Light Exposure
time frame: 2 weeks
Photosensitivity Symptoms
time frame: Single visit - one day

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - 18+ years old - reports a previous head injury that occurred at least 6 months ago - score of 2 or 3 (mild TBI) on OSU-TBI ID Survey - best-corrected visual acuity of at least 20/30 in both eyes - reliable visual field Exclusion Criteria: - pregnancy - significant afferent pupillary defect - previous history of neurodegenerative disease - intraocular pressure more than 21 mm Hg - significant visual field defect - active corneal pathology - history of retinal or optic nerve disease - strabismus (eye turn)

Additional Information

Official title The Head Injury-associated Photosensitivity and Pupillary Function (HIPP) Study
Principal investigator Andrew Hartwick, OD, PhD
Description The pupils inside the eyes constrict in response to light stimulation. Different classes of cells within the human retina initiate this response. Recent research suggests that one of the ganglion cell types involved in this pupil response also plays a role in the photophobia experienced by migraine sufferers. The main aim of this study is to determine whether this type of ganglion cell becomes 'hypersensitive' after traumatic brain injury, thereby contributing to symptoms of increased photosensitivity experienced by many of these individuals. In the first session of this study, subjects will be asked questions about their sensitivity to light and the reaction of their eyes' pupils to flashing red and blue lights will be measured. The subjects will be given a full eye examination to rule out other causes of increased photosensitivity. In some cases, subjects will be asked to attend a second session roughly two weeks later. They will be asked to wear a watch that measures their daily activity/sleep rhythms and light exposure during this inter-session period. During the second session, further testing of the pupil responses to blue and red flickering light will be performed.
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Ohio State University.