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Surgical Idiopathic Intracranial Hypertension Treatment Trial

NCT03501966 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2022-06-16

Study results available
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Summary

Randomized trial of adults (≥18 years old) with idiopathic intracranial hypertension and moderate to severe visual loss without substantial recent treatment who are randomly assigned to (1) medical therapy, (2) medical therapy plus ONSF, or (3) medical therapy plus VPS. The primary outcome is visual field mean deviation change at first of Month 6 (26 weeks) or time of treatment failure of the eligible eye(s), followed by a continuation study to assess time to treatment failure. The determination of eligible eye(s) is based on meeting the eligibility criteria at baseline.

Conditions

  • Idiopathic Intracranial Hypertension

Interventions

DRUG

Acetazolamide

Medical therapy including diet

PROCEDURE

Optic Nerve Sheath Fenestration

Medical therapy including diet + optic nerve sheath fenestration

PROCEDURE

Ventriculoperitoneal CSF Shunting

Medical therapy including diet + ventriculoperitoneal CSF Shunting

Sponsors & Collaborators

Principal Investigators

  • Michael Wall, MD · University of Iowa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
63 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-06
Primary Completion
2019-08-28
Completion
2019-08-28
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Puerto Rico

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03501966 on ClinicalTrials.gov