An interventional study of Pictor in Intracranial Pressure Increase, sponsored by Duke University. Terminated at 1 site in United States. Open to participants aged Up to 21 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-15.
Sponsored by Duke University · Not applicable, Interventional, and Screening
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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 12th largest by enrollment of the 15 interventional ones that give a count, is one of 4 that started in 2017, is one of 12 with no phase, and was the 18th 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: Up to 21 Years · all sexes · healthy volunteers too.
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. 4 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 3 is below the median of 50 across 81 interventional 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.
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3 of 29 have an industry lead sponsor. The 10 most frequent:
Duke University is the lead sponsor of 2,063 studies on the registry; 272 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 167 (82%) have results posted.
Duke University has 3 studies 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.
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The purpose of this study is to evaluate the vision and posterior segment of eyes in children and young adults less than 22 years of age with risk, suspicion, or past medical history significant for elevated intracranial pressure (ICP). Patients will have visual acuity and color vision tested. Assessment of the posterior segment will involve using a non-invasive (non-contact) imaging technique (i.e. a portable fundus camera in clinic and hospital settings).
The need for non-invasive evaluation of ICP is an active area of study. The current gold standard is intraventricular or intraparenchymal catheters but these are invasive, expensive, and require sedation; and thus the need for an effective non-invasive screening tool. The utility of funduscopy in identifying processes affecting ICP has long been recognized, i.e. papilledema, ocular venous engorgement, blurring of the optic disk. Studies have demonstrated that funduscopy may have a role in the qualitative assessment of increased ICP as a highly sensitive test. However, conventional bedside funduscopy does not allow for image capture and may necessitate pupillary dilation. Portable fundus cameras address these issues, allowing image capture and storage and the potential for non-mydriatic imaging, i.e. imaging without dilation of eyes. And as demonstrated in a recent study, portable fundus cameras are efficient (median exam time was 3 minutes and 24 seconds in a pediatric Emergency Department).
Additionally, ICP screening in asymptomatic patients remains limited. Patients being treated with medications for acne, specifically tetracyclines (e.g. minocycline and doxycycline), retinol, and isotretinol, are at particular risk for increased ICP but often are not identified until they are symptomatic (i.e. headaches, visual loss, papilledema). Symptom onset has been documented from 2 weeks up to 1 year from drug initiation. The percentage of patients with subclinical asymptomatic disease is unclear. This study would allow us to describe the presence of subclinical disease in our population and the role/utility of routine non-invasive screening methods.
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:
Image of back of each eye along with color vision and visual acuity assessment if able.
Diagnostic Test: Pictor
The back of each eye will be imaged with Pictor. Visual acuity and color vision will be checked if patient able to cooperate with exam.
Also known as: portable fundus camera
Changes in Posterior Segment as Measured by Fundus Camera
Time frame: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent
Changes in Visual Acuity
Time frame: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent
Changes in Color Vision as Measured by Standard Clinical Exam (i.e. Ishihara Testing)
Time frame: Each visit (up to 1 hour/visit) every 3 months for 1 year from signed consent
| Milestone | Vision/Eye Screening |
|---|---|
| Started | 3 |
| Completed | 0 |
| Not completed | 3 |
| Withdrew: Physician decision | 3 |
No measurements were reported for this outcome.
No measurements were reported for this outcome.
No measurements were reported for this outcome.
Collected over At baseline visit as only one visit occurred for each subject.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vision/Eye Screening | — | — | — |
| Age, Categorical(Participants) | Vision/Eye Screening |
|---|---|
| <=18 years | 3 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Age, Continuous(months) | Vision/Eye Screening |
|---|---|
| Mean | 59 ± 75 |
| Sex: Female, Male(Participants) | Vision/Eye Screening |
|---|---|
| Female | 1 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Vision/Eye Screening |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Vision/Eye Screening |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Vision/Eye Screening |
|---|---|
| United States | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2017 to primary completion in Dec 2018, 13 months.
Results were first posted in Feb 2022, 3 years 2 months after primary completion. A results delay was requested in Nov 2021.
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This study is terminated, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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