An observational study in Intracranial Pressure Increase, sponsored by Oculogica, Inc.. Completed at 3 sites in United States. Open to participants aged 4 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by Oculogica, Inc. · Observational
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Among 29 studies in Intracranial Hypertension with a site in United States — 3 open to participants now, 3 under way, none of them phase 3. Intracranial Hypertension · United States.
Among the 29 studies in Intracranial Hypertension with a site in United States, this one is the 6th largest by enrollment of the 14 observational ones that give a count, is one of 2 that started in 2018, is one of 14 observational ones, and was the 19th registered.
165 studies on the registry are indexed under Intracranial Hypertension; 36 are open to participants now.
Browse Intracranial Hypertension studies →3 of the 29 studies in Intracranial Hypertension with a site in United States are open now. Recruiting first, the newest first:
University of Louisville · Sites in United States
Ages 18–100
Brain Trauma Foundation · Sites in United States
Ages 18–65
University of Minnesota · Sites in United States
Ages 4+ · Healthy volunteers
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 23 Intracranial Hypertension studies recruiting now, 11 (48%) set no upper age limit and 5 (22%) stop at 75 or younger; 3 take children under 18; 5 take healthy volunteers.
This study: 4 Years to 70 Years · all sexes.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
29 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 60 is close to the median of 60 across 76 observational studies indexed under Intracranial Hypertension.
Median enrollment 16 across the 15 interventional studies, 36 across the 14 observational. Of the 22 that completed or were terminated, 4 (18%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 29 have an industry lead sponsor. The 10 most frequent:
Oculogica, Inc. is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
Oculogica, Inc. has 1 study filed under Intracranial Hypertension — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 29 studies in Intracranial Hypertension with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
The study is a prospective, multi-center, non-randomized, open label observational study. The objective of this study is to compare the accuracy of the EyeBOX to a clinical diagnosis of abnormal ICP as determined by an external ventriculostomy drain (EVD) or ventriculostomy catheter.
The study will enroll pediatric and adult patients with abnormal ICP. Subjects who meet all of the inclusion criteria and none of the exclusion criteria will be considered for enrollment into the study. There will be no enrollment restrictions based on race, ethnic origin, gender, or pregnancy status and efforts will be made to ensure that the benefits and burdens of research participation are distributed in an equitable manner. Subjects must require ICP monitoring for clinical indications. At the time when eye tracking is performed all patients must be awake with spontaneous eye opening.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
subjects with abnormal intracranial pressure
Diagnostic Test: EyeBOX for ICP
non-invasive ICP Score algorithm using eye-tracking data from the EyeBOX(TM) device, which tracks the movement of the pupils over time
Sensitivity and Specificity
EyeBOX assessment of abnormal ICP relative to invasive intracranial pressure monitor
Time frame: from time of enrollment through the period that ICP monitoring is required for clinical purposes up to 104 weeks
Plan to share: No
Ran from May 2018 to primary completion in May 2023, 60 months.
Of 44 observational studies under Intracranial Hypertension, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 62. This study's 60 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Oculogica, Inc.