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Can a shunt save sight in IIH? new study investigates

NCT ID NCT07707544

Disease control Sponsor: Sohag University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 16, 2026 · Last updated Jul 22, 2026 · Updated 3 times

Summary

This study looks at people with idiopathic intracranial hypertension (IIH), a condition where high pressure inside the skull can damage vision. Researchers will track which patients need a surgical shunt to relieve pressure versus those who improve with weight loss and medication. The goal is to find better ways to predict and prevent vision loss.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lumbo-peritoneal shunt and conservative management (lifestyle changes, acetazolamide, topiramate)
What this could lead to
If successful, this could help doctors predict which patients with IIH will need surgery to save their vision.
What could go wrong
This is a small, observational study, so results may not apply to everyone. Surgical shunts carry risks like infection or blockage.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2026

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 60 months

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

pseudotumor cerebri

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic intracranial hypertension

Contacts and locations

Locations

  • Sohag university

    Sohag, Sohag Governorate, 286, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.