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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2015-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Head Injury Traumatic Brain Injury (TBI) Photosensitivity Photophobia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Andrew Hartwick

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andrew Hartwick, OD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

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College of Optometry

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND

PMID: 28009763 (View on PubMed)

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.

Reference Type RESULT

PMID: 27464575 (View on PubMed)

Other Identifiers

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W81XWH-12-1-0434

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2013H0151

Identifier Type: -

Identifier Source: org_study_id