Idiopathic Intracranial Hypertension: Prognostic Factors and Multidisciplinary Management

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Idiopathic Intracranial Hypertension
• Intervention / Treatment: Procedure: lumbo-peritoneal shunt; Drug: Conservative Management: Centered on lifestyle modifications for weight reduction, alongside targeted medical therapies including carbonic anhydrase inhibitors (e.g., acetazolamide) and/or topiramate.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sohag, Egypt, 286
    • Sohag University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group 1 Idiopathic intracranial hypertension	Procedure: lumbo-peritoneal shunt; lumbo-peritoneal shunt to decrease the tension the patients those do not treated on medical treatment
Active Comparator: group 2 idiopathic increase 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.; Conservative Management: Centered on lifestyle modifications for weight reduction, alongside targeted medical therapies including carbonic anhydrase inhibitors (e.g., acetazolamide) and/or topiramate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Requirement for surgical intervention.	Surgical 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	6months

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: July 11, 2026
• First Submitted That Met QC Criteria: July 11, 2026
• First Posted (Actual): July 16, 2026

Study Record Updates

• Last Update Posted (Actual): July 16, 2026
• Last Update Submitted That Met QC Criteria: July 11, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Idiopathic intracranial hypertension
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Intracranial Hypertension; Pseudotumor Cerebri; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Thiazoles; Azoles; Carbohydrates; Sugars; Thiadiazoles; Hexoses; Monosaccharides; Fructose; Ketoses; Topiramate; Acetazolamide
• Other Study ID Numbers: Soh-Med-26-6-15MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes