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Pseudotumor Cerebri clinical trials

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NCT ID: NCT03556085 Active, not recruiting - Clinical trials for Idiopathic Intracranial Hypertension

Venous Sinus Stenting With the River Stent in IIH

Start date: August 24, 2018
Phase: N/A
Study type: Interventional

The objective of the study is to show that stenting the transverse-sigmoid sinus with the River stent is safe and has probable benefit to relieve clinical symptoms in subjects with idiopathic intracranial hypertension (IIH). The study will enroll 39 IIH subjects with moderate to severe visual field loss or severe headaches that have failed medical therapy. The primary safety endpoint is the rate of major adverse event at 12 months The primary probable benefit endpoint is a composite at 12 months of absence of significant sinus stenosis and clinically relevant improvement.

NCT ID: NCT03501966 Terminated - Clinical trials for Idiopathic Intracranial Hypertension

Surgical Idiopathic Intracranial Hypertension Treatment Trial

SIGHT
Start date: February 6, 2019
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT03304314 Recruiting - Pseudotumor Cerebri Clinical Trials

Multifocal Chromatic Pupilloperimetry in Patients With Pseudotumor Cerebri and Healthy Subjects.

Start date: November 3, 2017
Phase: N/A
Study type: Interventional

PTC(Pseudotumor cerebri) patients may develop increased Intracranial pressure (ICP) that can produces increased pressure around the distal optic nerve,which is likely followed by venule compression, ischemia, and loss of visual function.Vision loss in PTC is most commonly characterized by standard automated perimetry to measure peripheral visual field sensitivity. Pupillometry is a promising approach for functional assessment in PTC because it is noninvasive, objective, performed quickly with minimal patient cooperation needed. The feasibility of using chromatic multifocal pupillometry for assesment of PTC will be examined.

NCT ID: NCT03096743 Recruiting - Clinical trials for Idiopathic Intracranial Hypertension

Evaluating Raised Intracranial Pressure Using MR Elastography

Start date: January 10, 2017
Phase: N/A
Study type: Interventional

Investigators will compare magnetic resonance (MR) elastography measurements to other forms of noninvasive methods of detecting raised intracranial pressure, including optical coherence tomography (OCT) imaging measurements of the retinal nerve fiber layer (RNFL) and indirect signs of raised intracranial pressure on magnetic resonance imaging (MRI).

NCT ID: NCT02896452 Active, not recruiting - Clinical trials for Polycystic Ovarian Syndrome

Astronaut Vision Issues in a Ground Analog Population: Polycystic Ovary Syndrome

PCOS
Start date: October 1, 2016
Phase:
Study type: Observational

The investigators have documented a genetic predisposition for some astronauts to develop ophthalmologic issues (e.g., choroidal folds, cotton wool spots, optic disc edema). Women with polycystic ovary syndrome (PCOS) have several characteristics similar to those described in astronauts, including: higher homocysteine concentrations, increased incidence of intracranial hypertension, increased retinal nerve fiber layer thickness, increased incidence of white matter hyperintensities on MRI, increased androgen concentrations (or androgen responses to space flight), and indices of altered carbohydrate metabolism. Women with PCOS have not been evaluated in detail regarding the occurrence of other anomalies observed in astronauts including choroidal folds, optic disc edema and cotton wool spots as well as changes in cycloplegic refraction, and optic nerve sheath diameter. While researchers have evaluated one-carbon metabolism pathway polymorphisms re: PCOS, and initial studies show an association with certain one-carbon polymorphisms, none have looked at the complete set of SNPs proposed here. This study will evaluate women with PCOS and/or idiopathic intracranial hypertension (IIH) to assess one-carbon biochemistry and genetics and their possible correlation with ophthalmologic findings. The investigators aim to clarify the relationship of one carbon metabolism and ophthalmic findings in astronauts and patients with PCOS and/or IIH.

NCT ID: NCT02665858 Not yet recruiting - Clinical trials for Pediatric Idiopathic Intracranial Hypertension

OCT Imaging of Papilledema in Pediatric Idiopathic Intracranial Hypertension

Start date: February 2016
Phase: N/A
Study type: Interventional

Longitudinal clinical observation of optic nerve head, using slit lamp fundoscopy, guides therapy in pediatric idiopathic intracranial hypertension (IIH) patients; however, it remains a limited method of producing quantitative data in evaluating in patients with IIH. In this study we intend to compare, by using spectral domain optical coherence tomography (OCT), the mean retinal nerve fiber layer thickness and total retinal thickness (RNFLT/TRT) of the optic nerve of newly diagnosed IIH children to a control group. This will provide a quantitative measure for follow-up and treatment of this patient group.

NCT ID: NCT02541994 Terminated - Clinical trials for Benign Intracranial Hypertension

Axial Length and Central Corneal Thickness in Benign Intracranial Hypertension

Start date: September 2015
Phase: N/A
Study type: Interventional

Patients in for treatment of benign intracranial hypertension will undergo two tests that are not routinely performed for these patients: central corneal thickness and axial length of the eye. The data obtained from these measurements will be assessed to see if the correlate with aspects of vision loss including visual acuity, visual field status, optical coherence tomography (OCT) results, and fundus photographs.

NCT ID: NCT02513914 Recruiting - Pseudotumor Cerebri Clinical Trials

Operative Procedures vs. Endovascular Neurosurgery for Untreated Pseudotumor Trial

OPEN-UP
Start date: June 3, 2020
Phase: N/A
Study type: Interventional

Pseudotumor cerebri, also called idiopathic intracranial hypertension (IIH), is characterized by elevated intracranial pressure, headache, and if severe, vision loss. IIH is difficult to treat. Medical management may not adequately resolve the symptoms, and surgical management (primarily through cerebrospinal fluid [CSF] shunting) has a high failure rate. Recently, a relationship between IIH and stenosis of the dural venous sinuses (the veins that drain blood from the brain) has been reported. In patients with IIH in whom there is stenosis of one or more dural venous sinuses, placing a stent in the venous sinus may improve patients' objective symptoms (such as visual loss and papilledema) and subjective symptoms (such as headache). This study will determine whether dural venous sinus stenting is as effective as CSF shunting (considered the standard surgical treatment) in treating IIH patients who have moderate vision loss and stenosis of the dural venous sinuses.

NCT ID: NCT02394067 Not yet recruiting - Pseudotumor Cerebri Clinical Trials

Magnetic Resonance Venography Pre- and Post-Treatment in Patients With Idiopathic Intracranial Hypertension

Start date: June 2015
Phase: N/A
Study type: Observational

This prospective study will use magnetic resonance imaging of patients with Idiopathic Intracranial Hypertension (IIH), to determine if the common radiological finding of transverse venous sinus stenosis can be reversed with standard of care medical treatment of IIH.

NCT ID: NCT02149615 Recruiting - Optic Disc Swelling Clinical Trials

Antiacne Medications Pseudotumor Cerebri

AAMPTC
Start date: April 2014
Phase: Phase 4
Study type: Interventional

The exact incidence of optic disc swelling and idiopathic intracranial hypertension in patients using antiacne medication is not known so far. The investigators hypothesize that swelling of retinal nerve fibre layer measured by optical coherence tomography is more frequent then assumed so far.