Description
Inclusion Criteria:
- * Age ≥ 18 years old.
- * Diagnosis of Idiopathic Intracranial Hypertension according to the Modified Dandy Criteria.
- * Moderate to severe visual field loss defined by perimetric mean deviation of at least -8 dB but better than -30 dB in the worst eye.
- * Diagnostic cerebral venography demonstrating a pressure gradient of ≥ 8 mmHg across at least one segment of the dural venous sinus as measured during transfemoral cerebral venography
- * Failure of conservative or non-surgical therapies,by:
- 1. failed medical treatment including weight loss regimens OR
- 2. medication intolerance OR
- 3. medical treatment not indicated per investigator team
- * Women must not be able to become pregnant (e.g., post menopausal, surgically sterile, or using adequate birth control methods) for the duration of the study, and have a negative pregnancy test prior to treatment.
- a. Women on hormonal birth control must be on a stable dose for at least 3 months prior to enrollment
- * Signed informed consent obtained from the patient.
Exclusion Criteria:
- * CSF pressure \<25 cm H2O on lumbar puncture.
- * Abnormal CSF analysis such as elevated protein (\>60 mg/dL), low glucose (\<30 mg/dL), elevated cell count \>5 (unless traumatic lumbar puncture).
- * Previous CSF shunt or diversion procedure of any kind, or previous optic nerve sheath fenestration.
- * Uncontrolled second primary headache disorder (e.g. chronic migraine, medication overuse headache).
- * Allergic reaction to radiological iodine contrast agent.
- * Significant renal impairment (serum creatinine \>1.5 mg/dL).
- * Contraindication to general anesthesia.
- * Contraindication to aspirin, clopidogrel or other anticoagulants.
- * Presence of a cranial vascular abnormality (arteriovenous malformation, dural arteriovenous fistula, dural venous sinus thrombosis) or other intracranial mass.
- * Presence of a hypercoagulable state such as Factor V Leiden, Protein C or S deficiency or anti-cardiolipin syndrome.
- * Inability to provide reliable and reproducible visual field examinations (\>15% false- positive errors and/or failure to maintain fixation for eye monitoring).
- * Previous or ongoing eye disease such as glaucoma or retinopathy.
- * Pre-existing best corrected visual acuity worse than 20/200 in the study eye as measured by Snellen charts, without meeting eligible ophthalmological criteria in the contralateral eye.
- * Other pre-existing conditions accounting for optic atrophy that could produce irreversible vision loss in the study eye without meeting eligible ophthalmological criteria for IIH in the contralateral eye.
- * Condition associated with high risk of retinopathy (e.g. type I diabetes).
- * Previously (within the last 2 months) or currently exposed to a drug or substance that may elevate intracranial pressure (e.g. lithium, high-dose vitamin A, tetracyclines, anabolic steroids, chlordecone, amiodarone, diphenylhydantoin, nalidixic acid).
- * Pregnancy.
- * Presence of a physical, mental or social condition that could prevent adequate follow-up such as terminal illness, homelessness, lack of telephone, drug dependency or anticipation of a significant move away from a study site within one year of enrollment.
Ages Eligible for Study:
18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
No