Idiopathic intracranial hypertension | Signs and Symptoms Intracranial Hypertension | Absence Finding Localized Neurologic Examination | Absence Deformity Cerebral Ventricles | Absence Displacement Cerebral Ventricles | Absence Obstruction Cerebral Ventricles | Neurologic Examination Normal | Exception Raised cerebrospinal fluid pressure | Neuroimaging Abnormal | Exception Empty Sella turcica | Exception Optic nerve sheath Enlargement | Exception Venous sinus Stenosis | Exception Venous sinus Collapse
Item
1. 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
boolean
C0033845 (UMLS CUI [1])
C0037088 (UMLS CUI [2,1])
C0151740 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C0243095 (UMLS CUI [3,2])
C0392752 (UMLS CUI [3,3])
C0027853 (UMLS CUI [3,4])
C0332197 (UMLS CUI [4,1])
C0302142 (UMLS CUI [4,2])
C0007799 (UMLS CUI [4,3])
C0332197 (UMLS CUI [5,1])
C0012727 (UMLS CUI [5,2])
C0007799 (UMLS CUI [5,3])
C0332197 (UMLS CUI [6,1])
C0028778 (UMLS CUI [6,2])
C0007799 (UMLS CUI [6,3])
C0027853 (UMLS CUI [7,1])
C0205307 (UMLS CUI [7,2])
C1705847 (UMLS CUI [8,1])
C0428711 (UMLS CUI [8,2])
C0679575 (UMLS CUI [9,1])
C0205161 (UMLS CUI [9,2])
C1705847 (UMLS CUI [10,1])
C0014008 (UMLS CUI [10,2])
C1705847 (UMLS CUI [11,1])
C0228673 (UMLS CUI [11,2])
C2711450 (UMLS CUI [11,3])
C1705847 (UMLS CUI [12,1])
C0226504 (UMLS CUI [12,2])
C1261287 (UMLS CUI [12,3])
C1705847 (UMLS CUI [13,1])
C0226504 (UMLS CUI [13,2])
C0344329 (UMLS CUI [13,3])
Idiopathic intracranial hypertension Disease length
Item
2. diagnosis of iih for 6 weeks or less
boolean
C0033845 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Age
Item
3. age 18 to 60 years at time of diagnosis
boolean
C0001779 (UMLS CUI [1])
Reproducibility Visual loss Perimetry
Item
4. reproducible visual loss present on automated perimetry (in eye with greatest loss)
boolean
C1514863 (UMLS CUI [1,1])
C3665346 (UMLS CUI [1,2])
C0031061 (UMLS CUI [1,3])
Average Pellucid marginal corneal degeneration
Item
5. average pmd -2 db up to -5 db in the worst eye
boolean
C1510992 (UMLS CUI [1,1])
C0339288 (UMLS CUI [1,2])
Papilledema Bilateral
Item
6. presence of bilateral papilledema
boolean
C0030353 (UMLS CUI [1,1])
C0238767 (UMLS CUI [1,2])
Informed Consent
Item
7. able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
Childbearing Potential Contraceptive methods | Contraceptives, Oral | Transdermal contraceptive
Item
8. 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,
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0009905 (UMLS CUI [2])
C1456475 (UMLS CUI [3])
Treatment Total Idiopathic intracranial hypertension
Item
1. 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.
boolean
C0087111 (UMLS CUI [1,1])
C0439810 (UMLS CUI [1,2])
C0033845 (UMLS CUI [1,3])
Prior surgery Idiopathic intracranial hypertension | Optic nerve sheath Fenestration | Cerebrospinal fluid shunts procedure | Subtemporal decompression | Insertion of stent into vein
Item
2. previous surgery for iih including optic nerve sheath fenestration, csf shunting procedures, subtemporal decompression and venous stenting
boolean
C0455610 (UMLS CUI [1,1])
C0033845 (UMLS CUI [1,2])
C0228673 (UMLS CUI [2,1])
C0337280 (UMLS CUI [2,2])
C0007812 (UMLS CUI [3])
C0844214 (UMLS CUI [4])
C0398136 (UMLS CUI [5])
Gastric Bypass
Item
3. previous gastric bypass surgery
boolean
C0017125 (UMLS CUI [1])
Abnormality Neurologic Examination | Exception Papilledema | Exception Abnormal vision Related | Exception VIth nerve paresis
Item
4. abnormalities on neurologic examination aside from papilledema and its related visual loss or vi nerve paresis
boolean
C1704258 (UMLS CUI [1,1])
C0027853 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0030353 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C3665386 (UMLS CUI [3,2])
C0439849 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C3160842 (UMLS CUI [4,2])
CT result abnormal | MRI scan abnormal | Intracranial mass | Hydrocephalus | Dural sinus Thrombus | Arteriovenous malformation | Exception Empty Sella | Other Coding | Exception Sclera Flattened | Exception Venous stenosis
Item
5. 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
boolean
C0436539 (UMLS CUI [1])
C0436540 (UMLS CUI [2])
C0270614 (UMLS CUI [3])
C0020255 (UMLS CUI [4])
C4512343 (UMLS CUI [5,1])
C0087086 (UMLS CUI [5,2])
C0003857 (UMLS CUI [6])
C1705847 (UMLS CUI [7,1])
C0014008 (UMLS CUI [7,2])
C3846158 (UMLS CUI [8])
C1705847 (UMLS CUI [9,1])
C0036410 (UMLS CUI [9,2])
C0016203 (UMLS CUI [9,3])
C1705847 (UMLS CUI [10,1])
C0340753 (UMLS CUI [10,2])
Cerebrospinal Fluid Pressure Measurement
Item
6. csf pressure less than 200 mm water (patients may have repeat csf pressure measurements if the first is normal or no opening pressure obtained)
boolean
C0007809 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
CSF cell content Abnormal | Cells Increased | protein elevated
Item
7. abnormal csf contents: increased cells: > 5 cells, elevated protein:
boolean
C1304682 (UMLS CUI [1,1])
C0205161 (UMLS CUI [1,2])
C0007634 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
C0748024 (UMLS CUI [3])
Glucose low | Cerebrospinal fluid white blood cell count | Intraocular pressure | Refractive Errors | Hyperopia
Item
> 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
boolean
C0860801 (UMLS CUI [1])
C0855357 (UMLS CUI [2])
C0578862 (UMLS CUI [3])
C0034951 (UMLS CUI [4])
C0020490 (UMLS CUI [5])
Disease Causing Abnormal vision | Exception Refractive Errors | Exception Amblyopia | Optic Disk Drusen | Obstructive Sleep Apnea Untreated | Peripheral visual field examination Unable | Blood work up Abnormal | Anemia, severe | Leukopenia | Thrombocytopenia | Kidney Failure | Liver diseases | Diabetes Mellitus, Insulin-Dependent | Diabetic Retinopathy | Exposure to Lithium | Exposure to Vitamin A | Exposure to Cyclins | Condition Requirement Diuretics | Condition Requirement Oral steroid therapy | Condition Requirement Intravenous steroid injection | Condition Requirement Injection of steroid | Condition Requirement Antihypertensive Agents | Condition Requirement Topiramate | Medical condition Contraindicated Acetazolamide | Kidney Calculi | Pregnancy | Childbearing Potential Contraceptive methods Unwilling | Breast Feeding | Drug Dependence | Terminal illness | Telephone Lacking | Homelessness | Relocation of home | Hypersensitivity Pupil dilation procedure | Narrow angles Exclude Pupil dilation procedure
Item
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
boolean
C0012634 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C3665386 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0034951 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0002418 (UMLS CUI [3,2])
C0029128 (UMLS CUI [4])
C0520679 (UMLS CUI [5,1])
C0332155 (UMLS CUI [5,2])
C0522797 (UMLS CUI [6,1])
C1299582 (UMLS CUI [6,2])
C0005767 (UMLS CUI [7,1])
C0750430 (UMLS CUI [7,2])
C0205161 (UMLS CUI [7,3])
C0238644 (UMLS CUI [8])
C0023530 (UMLS CUI [9])
C0040034 (UMLS CUI [10])
C0035078 (UMLS CUI [11])
C0023895 (UMLS CUI [12])
C0011854 (UMLS CUI [13])
C0011884 (UMLS CUI [14])
C0332157 (UMLS CUI [15,1])
C0023870 (UMLS CUI [15,2])
C0332157 (UMLS CUI [16,1])
C0042839 (UMLS CUI [16,2])
C0332157 (UMLS CUI [17,1])
C0079183 (UMLS CUI [17,2])
C0348080 (UMLS CUI [18,1])
C1514873 (UMLS CUI [18,2])
C0012798 (UMLS CUI [18,3])
C0348080 (UMLS CUI [19,1])
C1514873 (UMLS CUI [19,2])
C0574135 (UMLS CUI [19,3])
C0348080 (UMLS CUI [20,1])
C1514873 (UMLS CUI [20,2])
C0563322 (UMLS CUI [20,3])
C0348080 (UMLS CUI [21,1])
C1514873 (UMLS CUI [21,2])
C1261311 (UMLS CUI [21,3])
C0348080 (UMLS CUI [22,1])
C1514873 (UMLS CUI [22,2])
C0003364 (UMLS CUI [22,3])
C0348080 (UMLS CUI [23,1])
C1514873 (UMLS CUI [23,2])
C0076829 (UMLS CUI [23,3])
C3843040 (UMLS CUI [24,1])
C1444657 (UMLS CUI [24,2])
C0000981 (UMLS CUI [24,3])
C0022650 (UMLS CUI [25])
C0032961 (UMLS CUI [26])
C3831118 (UMLS CUI [27,1])
C0700589 (UMLS CUI [27,2])
C0558080 (UMLS CUI [27,3])
C0006147 (UMLS CUI [28])
C1510472 (UMLS CUI [29])
C0679247 (UMLS CUI [30])
C0039457 (UMLS CUI [31,1])
C0332268 (UMLS CUI [31,2])
C0237154 (UMLS CUI [32])
C2699029 (UMLS CUI [33])
C0020517 (UMLS CUI [34,1])
C3267125 (UMLS CUI [34,2])
C1410927 (UMLS CUI [35,1])
C0332196 (UMLS CUI [35,2])
C3267125 (UMLS CUI [35,3])