Skip to content

Idiopathic Intracranial Hypertension: Prognostic Factors and Multidisciplinary Management

Neurosurgery Resident

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07707544
Enrollment
30
Registered
2026-07-16
Start date
2026-06-01
Completion date
2026-12-01
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Intracranial Hypertension

Keywords

Idiopathic intracranial hypertension

Brief summary

Several studies have investigated factors associated with visual deterioration in BIIP patients. Severe papilledema, delayed diagnosis, high CSF opening pressure, obesity, and visual field defects have been associated with poor prognosis. Optical Coherence Tomography has emerged as a valuable tool for monitoring retinal nerve fiber layer changes and detecting optic nerve damage. MRV abnormalities, particularly transverse sinus stenosis, have also gained increasing attention. Recent literature emphasizes the importance of multidisciplinary management involving neurosurgeons, neurologists, ophthalmologists, and radiologists.

Interventions

PROCEDURElumbo-peritoneal shunt

lumbo-peritoneal shunt to decrease the tension the patients those do not treated on medical treatment

DRUGConservative Management: Centered on lifestyle modifications for weight reduction, alongside targeted medical therapies including carbonic anhydrase inhibitors (e.g., acetazolamide) and/or topiramate.

Conservative Management: Centered on lifestyle modifications for weight reduction, alongside targeted medical therapies including carbonic anhydrase inhibitors (e.g., acetazolamide) and/or topiramate.

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Months to 60 Months
Healthy volunteers
Yes

Inclusion criteria

* •Patients fulfilling modified Dandy criteria. * Age above 18 years. * Confirmed diagnosis of IIH: * Elevated opening pressure on lumbar puncture (\>25 cm H2o) in lateral decubitus position). * Unremarkable neuroimaging (MRI/MRV) ruling out mass lesions, hydrocephalus, or venous sinus thrombosis. * Presence of papilledema documented by a neuro-ophthalmologist.

Exclusion criteria

-Secondary causes of intracranial hypertension. (Evidence of an intracranial mass, hydrocephalus, or structural lesion on neuroimaging). * Cerebral venous sinus thrombosis. * Intracranial space occupying lesions. * Previous optic nerve diseases. * Severe systemic illness affecting vision. * Pregnancy (due to restricted medication options like Topiramate). * Previous intracranial surgery or CSF shunting procedures

Design outcomes

Primary

MeasureTime frameDescription
visual outcome.6 months* Visual Acuity (VA): Best-corrected visual acuity using the Snellen chart (converted to LogMAR for statistical analysis). * Funduscopy: Grading of papilledema using the Frisén Scale (Grades 0-5). * Visual Field Testing: Automated perimetry (Humphrey Visual Field, 24-2 or 30-2 program) to detect blind spot enlargement or peripheral field loss Optical Coherence Tomography (OCT): Measuring Retinal Nerve Fiber Layer (RNFL) thickness and total macular volume to objectively quantify axonal swelling.

Secondary

MeasureTime frameDescription
Requirement for surgical intervention.6monthsSurgical Interventions: Reserved for patients presenting with fulminant or progressive vision loss, or those exhibiting failure of maximal medical therapy. Surgical options include ventriculoperitoneal (VP) shunt, lumboperitoneal (LP) shunt

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026