Chromatic Multifocal Pupillometer for Detection and Follow-up of Acute Head Injury (NCT02030366) | Clinical Trial Compass
UnknownNot Applicable
Chromatic Multifocal Pupillometer for Detection and Follow-up of Acute Head Injury
Israel40 participantsStarted 2015-10-01
Plain-language summary
Traumatic Brain Injury (TBI) is a common injury in combat, terrorist attacks and sports such as football and hockey. Unnecessary delays in the diagnosis and treatment of brain damage in patients who can benefit from evacuation procedures can lead to worse brain injury, worse outcome and, sometimes, unnecessary death. However, there is no reliable and sensitive method for diagnosis of TBI severity in the field. In this study we will examine the feasibility of using this a multifocal chromatic pupillometer for monitoring TBI, by examining the pupillary response to multifocal chromatic stimuli in intracranial pressure (ICP)-monitored severe TBI patients. As control, normal subjects will be tested for pupillary responses using this device.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Healthy subjects -
* Male or female patients, age between 18 and 70 years, inclusive
* Informed written consent will be obtained from all participants.
* Normal eye examination
* Best-corrected visual acuity (BCVA) of 20/20
* Normal color vision test (Roth-28-hue test)
* Written informed consent to participate in the study,
* TBI-patients:
* Male or female patients, age between 18 and 70 years, inclusive
* Initiation of study before the insertion of the ICP monitor.
* TBI diagnosed by history and clinical examination
* Glasgow Coma Scale (GCS) score between 3 and 8, inclusive
* Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (diffuse injury II-IV, evacuated and non-evacuated mass lesion, Marshall's CT Classification)
* Indication for ICP monitoring
* Written informed consent to participate in the study, signed by a family member and independent physician.
Exclusion Criteria:
* Healthy subjects
* History of past or present ocular disease
* Use of any topical or systemic medications that could adversely influence efferent pupil movements
* TBI-patients
* High levels of barbiturate medications as they abolish pupillary responsiveness
* Coma suspected to be primarily due to other causes (e.g. alcohol)
* Preexisting clinically significant disease or chronic condition that can be ascertained at the time of admission and could affect pupillary response or measurement (such as known retinal dystrophy disease, glauco…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pupillary response at 5 points of Visual field to blue and red light