Idiopathic Intracranial Hypertension Treatment Trial
I.I.H.T.T. -
NORDIC, N.I.H.
If you have patients with papilledema that you suspect have idiopathic intracranial hypertension we would greatly appreciate a referral for possible inclusion in this research study. Study drug is provided at no cost.
I.I.H.T.T. Objectives:
Determine the efficacy of a weight reduction and a low sodium diet with acetazolamide vs. diet plus placebo in reducing or reversing visual loss.
Use genetic biomarkers to investigate the cause of IIH.
Inclusion Criteria:
- Diagnosis of IIH by modified Dandy criteria: symptoms and signs of increased intracranial pressure in an alert patient. Normal neuroimaging and high CSF pressure with normal CSF contents. No other cause of high pressure present.
- Diagnosis of IIH for 6 weeks or less
- Age 18 - 60 years
- Reproducible visual loss present on perimetry
- Mean deviation -2 dB up to -5 dB in the worst eye
- Presence of bilateral papilledema
- Women must use an acceptable form of birth control
Exclusion Criteria (summary):
- CSF pressure < 200 mm water or abnormal contents
- Intraocular pressure > 28 mm Hg
- Refractive error > +/- 6.00 D sphere or > +/- 3.00 D cylinder in either eye
- Other disorders causing visual loss except for refractive error and amblyopia
- Inability to provide reliable and reproducible visual field exams
- Abnormal blood work-up indicating a medical or systemic condition associated with raised ICP
- Type I diabetes or diabetic retinopathy
- Recent exposure to a drug, substance or disorder that is associated with intracranial hypertension
- Other condition requiring diuretics, oral, I.V. or injectable steroids or other pressure lowering agents
- Use of topiramate, or diuretics for the treatment of IIH within 2 days of the Screening Exam
- Presence of a medical condition that would contraindicate use of the study drugs (acetazolamide)
- Pregnancy or unwillingness for subject to use contraception during the first year of the study
- Nursing mothers
Please send your patients to:
Dr. Rosa Tang, MD, MPH, MBA
MS Eye Care at The University Eye Institute
4901 Calhoun Rd, UH Entrance 2
Houston, Texas 77204
Phone: 713-942-2187
Fax: 713-942-0265
Call to schedule an appointment or download this form and fax it to us!
(please write NORDIC IIHTT under referral reason)
To download the flyer, click here. |