The Head Injury-associated Photosensitivity and Pupillary Function (HIPP) Study

Head Injury Clinical Trial

— HIPP  

Official title:

The Head Injury-associated Photosensitivity and Pupillary Function (HIPP) Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01942564
• Other study ID #: 2013H0151
• Secondary ID: W81XWH-12-1-0434
• Status: Completed
• Phase: N/A
• First received: September 6, 2013
• Last updated: September 20, 2017
• Start date: August 2013
• Est. completion date: December 2015

Study information

• Verified date: September 2017
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Brain Injuries
• Craniocerebral Trauma
• Head Injury
• Photophobia
• Photosensitivity
• Photosensitivity Disorders
• Traumatic Brain Injury (TBI)
• Wounds and Injuries

Locations

Country	Name	City	State
United States	College of Optometry	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

References & Publications (2)

Barker F, Cockerham G, Goodrich G, Hartwick A, Kardon R, Mick AB, Swanson M. Brain Injury Impact on the Eye and Vision. Optom Vis Sci. 2017 Jan;94(1):4-6. doi: 10.1097/OPX.0000000000001001. — View Citation

Yuhas PT, Shorter PD, McDaniel CE, Earley MJ, Hartwick AT. Blue and Red Light-Evoked Pupil Responses in Photophobic Subjects with TBI. Optom Vis Sci. 2017 Jan;94(1):108-117. doi: 10.1097/OPX.0000000000000934. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pupil Responses	The pupil fluctuation evoked by blue and red flickering lights will be measured in patients with a prior brain injury and compared to matched controls.	2 weeks
Secondary	Sleep Rhythms	Daily rhythms of sleep and activity will be assessed in subjects with prior brain injury and compared to matched controls.	2 weeks
Secondary	Light Exposure	The exposure to red, blue and green components of the light spectrum will be quantified in patients with a prior brain injury, and compared to matched controls.	2 weeks
Secondary	Photosensitivity Symptoms	Subjects will complete survey indicating symptoms they have experienced related to light sensitivity and will grade their discomfort after exposed to brief flashes of light.	Single visit - one day

External Links

•   Vision and Traumatic Brain Injury: The Outlook for Therapeutics - ARVO 2016 (Andrew Hartwick, speaker)