The Head Injury-associated Photosensitivity and Pupillary Function (HIPP) Study (HIPP)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01942564|
Recruitment Status : Completed
First Posted : September 16, 2013
Last Update Posted : September 25, 2017
|Condition or disease|
|Head Injury Traumatic Brain Injury (TBI) Photosensitivity Photophobia|
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.
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||The Head Injury-associated Photosensitivity and Pupillary Function (HIPP) Study|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2015|
- Pupil Responses [ Time Frame: 2 weeks ]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.
- Sleep Rhythms [ Time Frame: 2 weeks ]Daily rhythms of sleep and activity will be assessed in subjects with prior brain injury and compared to matched controls.
- Light Exposure [ Time Frame: 2 weeks ]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.
- Photosensitivity Symptoms [ Time Frame: Single visit - one day ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01942564
|United States, Ohio|
|College of Optometry|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Andrew Hartwick, OD, PhD||Ohio State University|