Trial ID or NCT#

NCT03501966

Status

not recruiting iconNOT RECRUITING

Purpose

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.

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 63 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Investigator(s)

Heather E. Moss, MD, PhD
Heather E. Moss, MD, PhD
Neuro-ophthalmology specialist
Associate Professor of Ophthalmology at the Stanford University Medical Center
Robert Dodd, MD, PhD
Robert Dodd, MD, PhD
Cerebrovascular neurosurgeon, Interventional neuroradiologist, Pituitary tumors neurosurgeon, Neurosurgeon, Neurosurgeon
Associate Professor of Neurosurgery, of Radiology and, by courtesy, of Otolaryngology-Head and Neck Surgery at the Stanford University Medical Center
Y. Joyce Liao, MD, PhD
Y. Joyce Liao, MD, PhD
Neuro-ophthalmology specialist
Associate Professor of Ophthalmology and of Neurology at the Stanford University Medical Center
Gordon Li, MD
Gordon Li, MD
Neurosurgeon
Associate Professor of Neurosurgery and, by courtesy, of Neurology and of Otolaryngology-Head and Neck Surgery at the Stanford University Medical Center
Andrea Lora Kossler, MD, FACS
Andrea Lora Kossler, MD, FACS
Ophthalmologic oncologist, Ophthalmic Plastic and Reconstructive Surgeon, Ophthalmologic surgeon, Ophthalmologist
Assistant Professor of Ophthalmology at the Stanford University Medical Center

Contact us to find out if this trial is right for you.

CONTACT

Mariana Nunez
(650) 497-7846