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NCT Number: NCT07707544

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Idiopathic Intracranial Hypertension Brain Diseases Central Nervous System Diseases Intracranial Hypertension Nervous System Diseases Pseudotumor Cerebri

Age range

18 month–60 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sohag university

Sohag, Sohag Governorate, 286, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

lumbo-peritoneal shunt

Procedure

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

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.

Primary outcomes

  1. visual outcome.

    Time frame: 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 outcomes

  1. Requirement for surgical intervention.

    Time frame: 6months

    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

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

Neurosurgery Resident

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 16, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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