Idiopathic Intracranial Hypertension Treatment Trial (IIHTT)
Idiopathic Intracranial Hypertension
About this trial
This is an interventional treatment trial for Idiopathic Intracranial Hypertension focused on measuring papilledema, vision loss, headache, obesity, women, diplopia, tinnitus
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of IIH by modified Dandy criteria Signs and symptoms of increased intracranial pressure Absence of localizing findings on neurologic examination Absence of deformity, displacement, or obstruction of the ventricular system and otherwise normal neurodiagnostic studies, except for evidence of increased cerebrospinal fluid pressure (>200 mm water). Abnormal neuroimaging except for empty sella turcica, optic nerve sheath enlargement, and smooth-walled non flow-related venous sinus stenosis or collapse106 should lead to another diagnosis Awake and alert No other cause of increased intracranial pressure present
- Diagnosis of IIH for 6 weeks or less
- Age 18 to 60 years at time of diagnosis
- Reproducible visual loss present on automated perimetry (in eye with greatest loss)
- Average PMD -2 dB up to -5 dB in the worst eye
- Presence of bilateral papilledema
- Able to provide informed consent
- Women of child-bearing potential must use an acceptable form of birth control during the intervention phase of the study. Acceptable forms include oral contraceptives, transdermal contraceptives,
Exclusion Criteria:
- Total treatment of IIH of more than two weeks (except for acetazolamide which is limited to 1 week). For every day on treatment there must be a one-day washout period.
- Previous surgery for IIH including optic nerve sheath fenestration, CSF shunting procedures, subtemporal decompression and venous stenting
- Previous gastric bypass surgery
- Abnormalities on neurologic examination aside from papilledema and its related visual loss or VI nerve paresis
- Abnormal CT or MRI scan (intracranial mass, hydrocephalus, dural sinus thrombus or arteriovenous malformation) other than empty sella, unfolded optic nerve sheaths, flattened sclera, or smooth- walled venous stenosis
- CSF pressure less than 200 mm water (patients may have repeat CSF pressure measurements if the first is normal or no opening pressure obtained)
- Abnormal CSF contents: increased cells: > 5 cells, elevated protein:
> 45 mg%, low glucose: < 30 mg% (If the lumbar puncture produces a cell count compatible with a traumatic needle insertion, the patient does not need to be excluded if the CSF WBC after correction is 5 wbc/mm3 or less- see Operations Manual for calculation) 8. Intraocular pressure currently > 28 mm Hg or > 30 mm Hg at any time in the past 9. Refractive error > +/- 6.00 sphere or > +/- 3.00 cylinder in either eye with the following exceptions: Subjects with myopia of >-6.00 D sphere but less than or equal to - 8.00 D sphere are eligible if 1)there are no abnormalities on ophthalmoscopy or fundus photos related to myopia that are associated with visual loss (such as staphyloma, retinal thinning in the posterior pole or more than mild optic disc tilt), and 2) the subject wears a contact lens for all perimetry examinations with the appropriate correction. If either the Site Investigator or the PRC director (or his designate) decides there are optic fundus abnormalities of myopia that are associated with visual loss, then 9. Subjects with hyperopia of > +6.00 D but less than or equal to
- 8.00 D sphere are eligible if 1) there is an unambiguous characteristic halo of peripapillary edema as opposed to features of a small crowded disc or other hyperopic change related to visual loss determined by the site investigator or the PRC director (or his designate) and 2) the subject wears a contact le 10. Other disorders causing visual loss except for refractive error and amblyopia including cells in the vitreous or iritis 11. Optic disc drusen on exam or in previous history 12. Presence of diagnosed untreated obstructive sleep apnea 13. Inability to provide reliable and reproducible visual field examination (failure to maintain fixation using an eye monitoring device, more than 15% false positive errors) 14. Abnormal blood work-up indicating a medical or systemic condition associated with raised ICP 15. Study blood results showing severe anemia, leukopenia or thrombocytopenia, renal failure, or hepatic disease, based on the Site Investigator's judgment 16. Type I diabetes or the presence of diabetic retinopathy 17. Exposure to a drug, substance or disorder that has been associated with elevation of intracranial pressure within 2 months of diagnosis such as lithium, vitamin A, various cyclines (see table in Operations Manual for conditions and drugs) 18. Other condition requiring diuretics, oral, I.V. or injectable steroids or other pressure lowering agents including topiramate (nasal, inhaled, or topical steroids are allowed since the systemic effects are small) 19. Presence of a medical condition such as renal stones that would contraindicate use of the study drug (acetazolamide) 20. Pregnancy or unwillingness for subject of childbearing potential to use contraception during the first year of the study 21. Breastfeeding mothers are excluded from participation unless willing to discontinue breastfeeding by the baseline visit 22. Presence of a physical, mental, or social condition likely to affect follow-up (drug addiction, terminal illness, no telephone, homeless) 23. Anticipation of a move from the site area within six months and unwillingness to return for follow-up at an IIHTT study site 24. Allergy to pupil dilating drops or narrow angles precluding safe dilation
Sites / Locations
- University of Alabama Birmingham
- Doheny Eye Center, University of Southern California
- The Eye Care Group, PC
- Bascom Palmer Eye Institute, University of Miami
- Neuro-Ophthamology & Balance Disorders Clinic
- Emory University
- University of Illinois
- Department of Ophthamology and Visual Sciences, University of Iowa
- University of Kentucky
- Louisiana State University Health Sciences Center - Earl K. Long Medical Center
- Greater Baltimore Medical Center Department Of Ophthamology
- Johns Hopkins Universtiy - Wilmer Ophthamological Institute
- Bethesda Neurology, LLC
- Massachusetts Eye and Ear Infirmary - Neuro-Ophthamology Service
- Michigan State University Department of Neurology
- William Beaumont Hosptial Research Institute
- University of Minnesota
- Saint Louis University Eye Institute
- University of St. Louis
- New Jersey Medical School/University Physicians Associates of New Jersey
- New York Eye and Ear Infirmary
- Weill Cornell Medical College
- The Mount Sinai Medical Center
- University of Rochester - Flaum Eye Institute
- Stony Brook University
- SUNY Upstate Medical University, Neurology Medical Service Group
- Duke Eye Center
- Raleigh Neurology Associates, PA
- Wake Forrest University Eye Center
- Ohio State University
- Dean A. McGee Eye Institute
- Oregon Health & Science University - Casey Eye Institute
- University of Pennsylvania, Department of Ophthamology
- The Methodist Hospital: Methodist Eye Associates
- Universtiy of Houston - University Eye Institute
- University of Texas Science Center
- University of Utah, John A. Moran Eye Center
- University of Virginia - Department of Ophthalmology
- Swedish Medical Center
- University of Calgary: Rockyview General Hospital
- Queen's University - Hotel Dieu Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Acetazolamide
Sugar pill
Acetazolamide given in escalating doses
Given in escalating "dose" (number of pill)