Idiopathic Intracranial Hypertension: Prognostic Factors and Multidisciplinary Management

NCT07707544 | Active Not Recruiting

• 1 other identifier: Soh-Med-26-6-15MS
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Intracranial Hypertension

Keywords

Idiopathic intracranial hypertension

Outcome Measures

Primary Outcomes (1)

• visual outcome.

  * 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.

  6 months

Secondary Outcomes (1)

• Requirement for surgical intervention.

  6months

Study Arms (2)

group 1 Idiopathic intracranial hypertension

ACTIVE COMPARATOR

Procedure: lumbo-peritoneal shunt

group 2 idiopathic increase intracranial hypertension

ACTIVE COMPARATOR

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

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

Interventions

lumbo-peritoneal shunt PROCEDURE

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

group 1 Idiopathic intracranial hypertension

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

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

group 2 idiopathic increase intracranial hypertension

Eligibility Criteria

• Age: 18 Months - 60 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sohag University: lead

Study Sites (1)

Sohag university

Sohag, Sohag Governorate, 286, Egypt

Location

MeSH Terms

Conditions

Pseudotumor Cerebri

Interventions

Acetazolamide; Topiramate

Condition Hierarchy (Ancestors)

Intracranial Hypertension; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Thiadiazoles; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Idiopathic intracranial hypertension: prognostic factors and multidisciplinary management

Study Record Dates

• First Submitted: July 11, 2026
• First Posted: July 16, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)