Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:04 PM
Ignite Modification Date:
2025-12-24 @ 4:04 PM
NCT ID:
NCT02030366
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02030366
Study Brief:
Protocol Section:
NCT02030366