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Idiopathic Intracranial Hypertension Treatment Trial (IIHTT)

Primary Purpose

Idiopathic Intracranial Hypertension

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Acetazolamide
Placebo
Formal weight loss counselling program
Sponsored by
St. Luke's-Roosevelt Hospital Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  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
  2. Diagnosis of IIH for 6 weeks or less
  3. Age 18 to 60 years at time of diagnosis
  4. Reproducible visual loss present on automated perimetry (in eye with greatest loss)
  5. Average PMD -2 dB up to -5 dB in the worst eye
  6. Presence of bilateral papilledema
  7. Able to provide informed consent
  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,

Exclusion Criteria:

  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.
  2. Previous surgery for IIH including optic nerve sheath fenestration, CSF shunting procedures, subtemporal decompression and venous stenting
  3. Previous gastric bypass surgery
  4. Abnormalities on neurologic examination aside from papilledema and its related visual loss or VI nerve paresis
  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
  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)
  7. 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

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Acetazolamide

Sugar pill

Arm Description

Acetazolamide given in escalating doses

Given in escalating "dose" (number of pill)

Outcomes

Primary Outcome Measures

Mean Change in Perimetric Mean Deviation
Treatment Effects on the Primary Outcome Variable, Mean change From Baseline to Month 6 in Perimetric Mean Deviation (PMD) in the Study Eye. Perimetric mean deviation is a measure of global visual field loss (mean deviation from age-corrected normal values), with a range of 2 to -32 dB; larger negative values indicate greater vision loss.

Secondary Outcome Measures

Mean Change of Papilledema Grade on Fundus Photography
Mean change at month 6 as compared to baseline. Frisén papilledema grade is an ordinal scale that uses ocular fundus features to rate the severity of papilledema; grade 0 indicates no features of papilledema and grade 5 indicates severe papilledema.
Visual Function Questionnaire (VFQ-25)
Visual Function Questionnaire (VFQ-25) total score, VFQ-25 10-item neuro-ophthalmic supplement total score: 0-100 (higher scores indicate better quality of life)
Visual Acuity (No. of Correct Letters)

Full Information

First Posted
October 28, 2009
Last Updated
November 23, 2018
Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
National Eye Institute (NEI), University of Rochester, University of Iowa, University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT01003639
Brief Title
Idiopathic Intracranial Hypertension Treatment Trial
Acronym
IIHTT
Official Title
A Multicenter, Double-blind, Randomized, Placebo-controlled Study of Weight-Reduction and/or Low Sodium Diet Plus Acetazolamide vs Diet Plus Placebo in Subjects With Idiopathic Intracranial Hypertension With Mild Visual Loss
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Luke's-Roosevelt Hospital Center
Collaborators
National Eye Institute (NEI), University of Rochester, University of Iowa, University of California, Davis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Idiopathic intracranial hypertension (IIH), also called pseudotumor cerebri, is a disorder of elevated intracranial pressure of unknown cause [Corbett, et al., 1982; Wall, et al., 1991]. Its incidence is 22.5 new cases each year per 100,000 overweight women of childbearing age, and is rising [Garrett, et al., 2004] in parallel with the obesity epidemic. It affects about 100,000 Americans. Most patients suffer debilitating headaches. Because of pressure on the optic nerve (papilledema), 86% have some degree of permanent visual loss and 10% develop severe visual loss [Wall, et al., 1991]. Interventions to prevent loss of sight, all with unproven efficacy, include diet, diuretics such as acetazolamide, repeated spinal taps, optic nerve sheath fenestration surgery, and cerebrospinal fluid (CSF) shunting procedures. The purported goal of these therapies is to lower intracranial pressure; however, it is unclear which treatments work and by what mechanism. None of these strategies has been verified by properly designed clinical trials. Thus, there is confusion, uncertainty, and weak scientific rationales to guide treatment decisions. This trial will study subjects who have mild visual loss from IIH to (1) establish convincing, evidence-based treatment strategies for IIH to restore and protect vision, (2) follow subjects up to 4 years to observe the long-term treatment outcomes and (3) determine the cause of IIH. To meet those aims, the trial will be divided into a 12-month intervention phase and a 3-year observational phase. Subjects are not required to complete the observational phase of the study, but will be asked to do so and consented for the observational phase of the study at the conclusion of the intervention phase (12 months).
Detailed Description
Clinical Phase: Phase II Investigators: NORDIC Network sites Study Centers: 38 study centers Coordinating Center - University of Rochester Statistical Center - University of Rochester Study Period Planned enrollment duration: 2 years Planned duration of treatment: 6 months followed by open-label treatment Planned duration of follow-up: 4.5 years Study Objectives: The primary objective is determining the efficacy of diet plus acetazolamide vs diet alone in reducing or reversing visual loss in subjects with mild visual loss. The secondary objective is to identify proteomic and genetic risk factors for IIH by screening a large cohort of IIH patients and controls. Study Population This project will enroll 166 individuals with IIH who are 18-60 years of age. We anticipate that the population will be primarily composed of women in the childbearing years that are overweight. 154 control subjects will also be enrolled. Control subjects will be matched as closely as possibly by age, sex, race, ethnicity and weight to subjects enrolled at the site. Study Design: Multi-center, double-blind randomized intervention study followed by a 4-year observation period. Subjects will be randomized to diet and acetazolamide or diet and placebo. The study will use 250 mg acetazolamide or matching placebo tablets taken with food at meals and at bedtime. The subject will begin with one tablet four times daily, at meals and at bedtime for the first week. Beginning on Day 7, subjects will increase the dosage by 1 tablet every 4 days until a final dosage of 4 tablets four times daily (4 grams) is reached or side effects prohibit increasing the dosage further. If the study drug is not tolerated at a dose of 250 mg, then 125 mg (1/2 tablet) will be tried. If this is not tolerated, no pharmacologic treatment will be given. After the 6 month visit, all subjects will transition from study medication to acetazolamide (open label) by replacing one tablet of study drug with 250 mg of acetazolamide every four days. The acetazolamide dose will be titrated in a manner similar to the initial study drug schedule to the maximum tolerated dose of acetazolamide. To avoid treating subjects (who may have initially been assigned to placebo) unnecessarily, any subject with grade 0-1 papilledema will be tapered off study drug but not placed on acetazolamide unless they have persisting headaches or pulse-synchronous tinnitus. If so, they will be placed on acetazolamide regardless of the low papilledema grade. At the 9-month follow-up visit, we will make sure that the subjects' vision is stable after the transition off of study medication. After the 9 month visit, medication will be prescribed by the subject's treating physician. The intervention phase of the study will end at the subject's 12 month visit and subjects will be invited to participate in the observational phase of the study and consented to do so if willing. Number of Subjects: 166 subjects with IIH and 154 control subjects Main Inclusion Criteria Diagnosis of IIH by modified Dandy criteria 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)* perimetric mean deviation (PMD) -2 decibel (dB) up to -5 dB in the worst eye Presence of bilateral papilledema Able to provide informed consent or parental permission with appropriate assent Main Exclusion Criteria Total treatment of IIH of more than one week in the past six weeks Corticosteroids or surgery used for IIH treatment within the past two months Abnormalities on neurologic examination aside from papilledema and its related visual loss or VI nerve paresis (unless pre-existing and unrelated to IIH) Abnormal CT or MRI scan (intracranial mass, hydrocephalus, dural sinus thrombus or arteriovenous malformation) other than empty sella, dilated optic nerve sheath, flattened sclera, or secondary Chiari 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, elevated protein, low glucose) Intraocular pressure currently > 28 mm Hg or > 30 mm Hg at any time in the past Refractive error > +/- 6.00 sphere or > +/- 3.00 cylinder in either eye Other disorders causing visual loss except for refractive error and amblyopia including cells in the vitreous or iritis Inability to provide reliable and reproducible visual field examination (failure to maintain fixation using an eye monitoring device, more than 15% false positive errors Abnormal blood work-up indicating a medical or systemic condition associated with raised intracranial pressure (ICP) 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, tetracycline, steroid withdrawal (see table in Manual of Procedures (MOP) for conditions and drugs) Other condition requiring diuretics, steroids or other pressure lowering agents including topiramate Presence of a medical condition such as renal stones that would contraindicate use of the study drugs (acetazolamide) Pregnancy or unwillingness for subject with childbearing potential to use contraception during the first year of the study Presence of a physical, mental, or social condition likely to affect follow-up (drug addiction, terminal illness, no telephone, homeless) Anticipation of a move from the site area within six months and unwillingness to return for follow-up. Route and Dosage Form: 250 mg acetazolamide tablets or matching placebo taken with food 4 times daily. Subjects will titrate to a maximum dose of 4 tablets 4 times daily (4 grams) as tolerated. If a subject is not able to tolerate a dose of 250 mg, 125 mg (1/2 tablet) may be tried. If this is not tolerated, no pharmacologic treatment will be given. Duration of Treatment: 6 months of randomized treatment followed by open label acetazolamide treatment. After the 9-month visit medication will be prescribed by the subject's treating physician. The intervention phase of the study will end at Month 12 and the subject invited to continue in the observational phase. Primary Outcome Measure(s): The primary outcome measure is the change from baseline to Month 6 in PMD (perimetric mean deviation) in the eye with the most severe initial visual loss. Secondary Outcome Measure: CSF pressure measurement by lumbar puncture Number of abnormal perimetry test locations Visual field examination ratings (improved, remained the same, or worsened) Papilledema grade QOL assessments Dietary Outcomes (BMI, Waist circumference, urinary sodium) Safety Outcomes: Adverse events will be tabulated by treatment group, severity, and perceived relationship to the study intervention Sample Size Considerations

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Intracranial Hypertension
Keywords
papilledema, vision loss, headache, obesity, women, diplopia, tinnitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetazolamide
Arm Type
Active Comparator
Arm Description
Acetazolamide given in escalating doses
Arm Title
Sugar pill
Arm Type
Placebo Comparator
Arm Description
Given in escalating "dose" (number of pill)
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Other Intervention Name(s)
naproxen, acetaminophen, aspirin, ibuprofen, codein, butalbital
Intervention Description
Subjects will begin with four 250 mg tablets daily. Tablets will be divided among two doses, taken with meals. Beginning on day 7, subjects will increase the dose by 1 pill every week until 16 tablets daily is reached (4 grams acetazolamide or placebo) or side effects prohibit increasing the dosage further. Thus, subjects who are able to tolerate the study medication will reach the maximum dose by day 84.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
naproxen, acetaminophen, aspirin, ibuprofen, codein, butalbital
Intervention Description
Subjects will begin with four tablets daily. Tablets will be divided among two doses, taken with meals. Beginning on day 7, subjects will increase the dose by 1 pill every week until 16 tablets daily is reached (4 grams acetazolamide or placebo) or side effects prohibit increasing the dosage further. Thus, subjects who are able to tolerate the study medication will reach the maximum dose by day 84.
Intervention Type
Behavioral
Intervention Name(s)
Formal weight loss counselling program
Other Intervention Name(s)
naproxen, acetaminophen, aspirin, ibuprofen, codein, butalbital
Intervention Description
Teleconference, web-based from central location, using site visits and subject self-assessment tools
Primary Outcome Measure Information:
Title
Mean Change in Perimetric Mean Deviation
Description
Treatment Effects on the Primary Outcome Variable, Mean change From Baseline to Month 6 in Perimetric Mean Deviation (PMD) in the Study Eye. Perimetric mean deviation is a measure of global visual field loss (mean deviation from age-corrected normal values), with a range of 2 to -32 dB; larger negative values indicate greater vision loss.
Time Frame
base line and 6 months
Secondary Outcome Measure Information:
Title
Mean Change of Papilledema Grade on Fundus Photography
Description
Mean change at month 6 as compared to baseline. Frisén papilledema grade is an ordinal scale that uses ocular fundus features to rate the severity of papilledema; grade 0 indicates no features of papilledema and grade 5 indicates severe papilledema.
Time Frame
Baseline and 6 Months
Title
Visual Function Questionnaire (VFQ-25)
Description
Visual Function Questionnaire (VFQ-25) total score, VFQ-25 10-item neuro-ophthalmic supplement total score: 0-100 (higher scores indicate better quality of life)
Time Frame
baseline
Title
Visual Acuity (No. of Correct Letters)
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Wall, MD
Organizational Affiliation
University of Iowa
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Doheny Eye Center, University of Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
The Eye Care Group, PC
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Bascom Palmer Eye Institute, University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Neuro-Ophthamology & Balance Disorders Clinic
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Department of Ophthamology and Visual Sciences, University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
55242
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Louisiana State University Health Sciences Center - Earl K. Long Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70810
Country
United States
Facility Name
Greater Baltimore Medical Center Department Of Ophthamology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Johns Hopkins Universtiy - Wilmer Ophthamological Institute
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Bethesda Neurology, LLC
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Massachusetts Eye and Ear Infirmary - Neuro-Ophthamology Service
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Michigan State University Department of Neurology
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48823
Country
United States
Facility Name
William Beaumont Hosptial Research Institute
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Saint Louis University Eye Institute
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
University of St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New Jersey Medical School/University Physicians Associates of New Jersey
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States
Facility Name
New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
The Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of Rochester - Flaum Eye Institute
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Stony Brook University
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
SUNY Upstate Medical University, Neurology Medical Service Group
City
Syracuse
State/Province
New York
ZIP/Postal Code
13202
Country
United States
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Raleigh Neurology Associates, PA
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Wake Forrest University Eye Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Dean A. McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health & Science University - Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
University of Pennsylvania, Department of Ophthamology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
The Methodist Hospital: Methodist Eye Associates
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Universtiy of Houston - University Eye Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77204
Country
United States
Facility Name
University of Texas Science Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Utah, John A. Moran Eye Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Virginia - Department of Ophthalmology
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98014
Country
United States
Facility Name
University of Calgary: Rockyview General Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 1P9
Country
Canada
Facility Name
Queen's University - Hotel Dieu Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5G2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24756514
Citation
NORDIC Idiopathic Intracranial Hypertension Study Group Writing Committee; Wall M, McDermott MP, Kieburtz KD, Corbett JJ, Feldon SE, Friedman DI, Katz DM, Keltner JL, Schron EB, Kupersmith MJ. Effect of acetazolamide on visual function in patients with idiopathic intracranial hypertension and mild visual loss: the idiopathic intracranial hypertension treatment trial. JAMA. 2014 Apr 23-30;311(16):1641-51. doi: 10.1001/jama.2014.3312.
Results Reference
result
PubMed Identifier
28492874
Citation
Wang JK, Kardon RH, Ledolter J, Sibony PA, Kupersmith MJ, Garvin MK; OCT Sub-Study Committee and the NORDIC Idiopathic Intracranial Hypertension Study Group. Peripapillary Retinal Pigment Epithelium Layer Shape Changes From Acetazolamide Treatment in the Idiopathic Intracranial Hypertension Treatment Trial. Invest Ophthalmol Vis Sci. 2017 May 1;58(5):2554-2565. doi: 10.1167/iovs.16-21089.
Results Reference
derived
PubMed Identifier
28130349
Citation
Wall M, Thurtell MJ; NORDIC Idiopathic Intracranial Hypertension Study Group. Optic disc haemorrhages at baseline as a risk factor for poor outcome in the Idiopathic Intracranial Hypertension Treatment Trial. Br J Ophthalmol. 2017 Sep;101(9):1256-1260. doi: 10.1136/bjophthalmol-2016-309852. Epub 2017 Jan 27.
Results Reference
derived
PubMed Identifier
27694262
Citation
Bruce BB, Digre KB, McDermott MP, Schron EB, Wall M; NORDIC Idiopathic Intracranial Hypertension Study Group. Quality of life at 6 months in the Idiopathic Intracranial Hypertension Treatment Trial. Neurology. 2016 Nov 1;87(18):1871-1877. doi: 10.1212/WNL.0000000000003280. Epub 2016 Sep 30.
Results Reference
derived
PubMed Identifier
26934136
Citation
Wall M, Johnson CA, Cello KE, Zamba KD, McDermott MP, Keltner JL; NORDIC Idiopathic Intracranial Hypertension Study Group. Visual Field Outcomes for the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT). Invest Ophthalmol Vis Sci. 2016 Mar;57(3):805-12. doi: 10.1167/iovs.15-18626.
Results Reference
derived
PubMed Identifier
26778344
Citation
Sibony PA, Kupersmith MJ; OCT Substudy Group of the NORDIC Idiopathic Intracranial Hypertension Treatment Trial. "Paton's Folds" Revisited: Peripapillary Wrinkles, Folds, and Creases in Papilledema. Ophthalmology. 2016 Jun;123(6):1397-9. doi: 10.1016/j.ophtha.2015.12.017. Epub 2016 Jan 14. No abstract available.
Results Reference
derived
PubMed Identifier
26618282
Citation
Cello KE, Keltner JL, Johnson CA, Wall M; NORDIC Idiopathic Intracranial Hypertension Study Group. Factors Affecting Visual Field Outcomes in the Idiopathic Intracranial Hypertension Treatment Trial. J Neuroophthalmol. 2016 Mar;36(1):6-12. doi: 10.1097/WNO.0000000000000327.
Results Reference
derived
PubMed Identifier
26335066
Citation
Sibony PA, Kupersmith MJ, Feldon SE, Wang JK, Garvin M; OCT Substudy Group for the NORDIC Idiopathic Intracranial Hypertension Treatment Trial. Retinal and Choroidal Folds in Papilledema. Invest Ophthalmol Vis Sci. 2015 Sep;56(10):5670-80. doi: 10.1167/iovs.15-17459.
Results Reference
derived
PubMed Identifier
26024112
Citation
Fischer WS, Wall M, McDermott MP, Kupersmith MJ, Feldon SE; NORDIC Idiopathic Intracranial Hypertension Study Group. Photographic Reading Center of the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT): Methods and Baseline Results. Invest Ophthalmol Vis Sci. 2015 May;56(5):3292-303. doi: 10.1167/iovs.15-16465.
Results Reference
derived
PubMed Identifier
25370513
Citation
OCT Sub-Study Committee for NORDIC Idiopathic Intracranial Hypertension Study Group; Auinger P, Durbin M, Feldon S, Garvin M, Kardon R, Keltner J, Kupersmith MJ, Sibony P, Plumb K, Wang JK, Werner JS. Baseline OCT measurements in the idiopathic intracranial hypertension treatment trial, part II: correlations and relationship to clinical features. Invest Ophthalmol Vis Sci. 2014 Nov 4;55(12):8173-9. doi: 10.1167/iovs.14-14961.
Results Reference
derived
PubMed Identifier
25370510
Citation
OCT Sub-Study Committee for NORDIC Idiopathic Intracranial Hypertension Study Group; Auinger P, Durbin M, Feldon S, Garvin M, Kardon R, Keltner J, Kupersmith M, Sibony P, Plumb K, Wang JK, Werner JS. Baseline OCT measurements in the idiopathic intracranial hypertension treatment trial, part I: quality control, comparisons, and variability. Invest Ophthalmol Vis Sci. 2014 Nov 4;55(12):8180-8. doi: 10.1167/iovs.14-14960. Erratum In: Invest Ophthalmol Vis Sci. 2016 Dec 1;57(15):6909.
Results Reference
derived
PubMed Identifier
24781936
Citation
Keltner JL, Johnson CA, Cello KE, Wall M; NORDIC Idiopathic Intracranial Hypertension Study Group. Baseline visual field findings in the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT). Invest Ophthalmol Vis Sci. 2014 Apr 29;55(5):3200-7. doi: 10.1167/iovs.14-14243.
Results Reference
derived
PubMed Identifier
24756302
Citation
Wall M, Kupersmith MJ, Kieburtz KD, Corbett JJ, Feldon SE, Friedman DI, Katz DM, Keltner JL, Schron EB, McDermott MP; NORDIC Idiopathic Intracranial Hypertension Study Group. The idiopathic intracranial hypertension treatment trial: clinical profile at baseline. JAMA Neurol. 2014 Jun;71(6):693-701. doi: 10.1001/jamaneurol.2014.133.
Results Reference
derived

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Idiopathic Intracranial Hypertension Treatment Trial

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