Surgical Idiopathic Intracranial Hypertension Treatment Trial
Public ClinicalTrials.gov record NCT03501966. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Randomized Trial of Medical Therapy (MT) vs. MT Plus Optic Nerve Sheath Fenestration vs. MT Plus Ventriculoperitoneal Cerebrospinal Fluid Shunting in Subjects With Idiopathic Intracranial Hypertension and Moderate to Severe Visual Loss
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT03501966
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 7 participants
Conditions and interventions
Conditions
Interventions
- Acetazolamide Drug
- Optic Nerve Sheath Fenestration Procedure
- Ventriculoperitoneal CSF Shunting Procedure
Drug · Procedure
Eligibility (public fields only)
- Age range
- 18 Years to 63 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 6, 2019 (Actual)
- Primary completion
- Aug 28, 2019 (Actual)
- Completion
- Aug 28, 2019 (Actual)
- Last update posted
- Jun 16, 2022
2019
United States locations
- U.S. sites
- 33
- U.S. states
- 23
- U.S. cities
- 29
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | — |
| NeuroEyeOrbit Institute | Los Angeles | California | 90048 | — |
| Stanford University | Palo Alto | California | 94303 | — |
| University of Colorado - Anschutz Medical Campus | Aurora | Colorado | 80045 | — |
| The Eye Care Group | Orange | Connecticut | 06477 | — |
| University of Miami | Miami | Florida | 33136 | — |
| Northwestern Medicine | Chicago | Illinois | 60611 | — |
| University of Illinois at Chicago | Chicago | Illinois | 60612 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Kansas School of Medicine | Prairie Village | Kansas | 64134 | — |
| University of Kentucky | Lexington | Kentucky | 40536 | — |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21287 | — |
| Bethesda Neurology, LLC | North Bethesda | Maryland | 20852 | — |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | — |
| University of Minnesota | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic | Rochester | Minnesota | 55905 | — |
| Washington University in St. Louis | St Louis | Missouri | 36110 | — |
| Saint Louis University | St Louis | Missouri | 63104 | — |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198 | — |
| State University of New York at Stony Brook | East Setauket | New York | 11733 | — |
| New York Eye & Ear Infirmary of Mount Sinai | New York | New York | 10003 | — |
| New York University School of Medicine | New York | New York | 10016 | — |
| University of Rochester | Rochester | New York | 14642 | — |
| Ohio Neuro-Ophthalmology, Orbital Disease and Oculoplastics | Columbus | Ohio | 43214 | — |
| Dean McGee Eye Institute | Oklahoma City | Oklahoma | 73104 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Neuro-Eye Clinical Trials-Houston | Houston | Texas | 77005 | — |
| University of Utah | Salt Lake City | Utah | 84132 | — |
| University of Virginia | Charlottesville | Virginia | 22904 | — |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | — |
| Swedish Medical Center | Seattle | Washington | 98122 | — |
| University of Wisconsin | Madison | Wisconsin | 53705 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 3 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03501966, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jun 16, 2022 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03501966 live on ClinicalTrials.gov.