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.
Who can participate
Age range18 Years – 63 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Diagnosis of IIH by modified Dandy criteria (Table 4)
✓. Age 18 to \<64 years at time of consent
✓. Age 18 to \<61 years at time of diagnosis (time of diagnosis is the time at which the patient meets the modified Dandy criteria, usually after the lumbar puncture results are reviewed)
✓. Presence of bilateral papilledema
✓. Lumbar puncture within 6 weeks of screening visit or completed as part of screening: Opening CSF pressure \>250 mmH2O or 200 to 250 mmH2O with at least one of the following:
Exclusion criteria
✕. Able to provide informed consent
✕. Investigator believes participant is a good candidate for the study, including the probability of returning for follow-up.
✕. Visual field loss meeting the following criteria based on two full threshold 24-2 size V tests reviewed by the VFRC:
✕. Visual acuity better than 20/200 (39 or more letters correct)
✕. Treatment of IIH within the past 3 months with either (1) the maximally tolerated dosage of acetazolamide for at least one week or (2) more than one month of acetazolamide with a cumulative dosage of more than 45 grams 'Maximally-tolerated dose' is defined as dosage was reached where dosage could not be increased further either because of side effects or because a daily total dosage of 4 grams per day was reached.
✕. Treatment of IIH within the past 3 months with either (1) the maximally tolerated dosage of methazolamide for at least one week or (2) more than one month of methazolamide with a cumulative dosage of more than 4.5 grams 'Maximally-tolerated dose' is defined as dosage was reached where dosage could not be increased further either because of side effects or because a daily total dosage of 400 mg per day was reached.
✕. Treatment with topiramate within two months and average cumulative dosage for the preceding month of more than 700 mg per week
✕. Previous surgery for IIH, including ONSF, CSF shunting, subtemporal decompression, or venous sinus stenting; gastric surgery for obesity is allowed