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

NCT01942564 | Completed

• 2 other identifiers: 2013H0151W81XWH-12-1-0434
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Head Injury; Traumatic Brain Injury (TBI); Photosensitivity; Photophobia

Keywords

traumatic brain injury; photophobia; photosensitivity; pupil

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Sleep Rhythms

  2 weeks

• Light Exposure

  2 weeks

• Photosensitivity Symptoms

  Single visit - one day

Study Arms (2)

Case Subjects

1. Age 18 years or older 2. Had a head injury that occurred at least 6 months prior to entering study 3. Have found lights more bothersome since injury

Control Subjects

1. Age 18 years or older 2. Have not had a previous head injury 3. Have had a full eye examination at Ohio State University College of Optometry during last 6 months.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cases: Age 18 or older with symptoms of increased photosensitivity since experiencing a head injury. Controls: Matched to cases in age, sex and race.

You may qualify if:

• + 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ohio State University: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (1)

College of Optometry

Columbus, Ohio, 43210, United States

Location

Related 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. No abstract available.

  PMID: 28009763 BACKGROUND

• 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.

  PMID: 27464575 RESULT

MeSH Terms

Conditions

Craniocerebral Trauma; Brain Injuries, Traumatic; Photosensitivity Disorders; Photophobia

Condition Hierarchy (Ancestors)

Trauma, Nervous System; Nervous System Diseases; Wounds and Injuries; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Hartwick, OD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 6, 2013
• First Posted: September 16, 2013
• Study Start: August 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: September 25, 2017

Record last verified: 2017-09

Locations

US (1)