Chromatic Multifocal Pupillometer for Detection and Follow-up of Acute Head Injury

Launched by SHEBA MEDICAL CENTER · Jan 6, 2014

Keywords

ClinConnect Summary

This clinical trial is studying a new device called the chromatic multifocal pupillometer, which is designed to help detect and monitor the severity of traumatic brain injuries (TBI). TBIs can happen in situations like sports, combat, or accidents, and it's crucial to diagnose and treat them quickly to prevent further injury or complications. The trial aims to see how well this device can measure how the pupils react to light in patients with severe TBIs, compared to healthy individuals.

To participate in the study, you need to be between 18 and 70 years old and meet certain health criteria, such as having normal vision and no significant eye diseases. For patients with TBIs, they must have a specific level of consciousness and evidence of brain injury confirmed by a CT scan. If eligible, participants can expect to undergo tests using the pupillometer, which will help researchers understand its effectiveness in evaluating brain injuries. It's important to note that participants will need to provide informed consent, and for TBI patients, consent must also be obtained from a family member and an independent physician.

Gender

ALL

Eligibility criteria

• 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, glaucoma or dense cataract.