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Surgical Idiopathic Intracranial Hypertension Treatment Trial (SIGHT)

Primary Purpose

Idiopathic Intracranial Hypertension

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Acetazolamide
Optic Nerve Sheath Fenestration
Ventriculoperitoneal CSF Shunting
Sponsored by
Jaeb Center for Health Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Intracranial Hypertension focused on measuring headache, idiopathic intracranial hypertension (IIH), shunt, fenestration, acetazolamide, visual loss, diamox

Eligibility Criteria

18 Years - 63 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subject Eligibility Criteria Inclusion Criteria

    1. Diagnosis of IIH by modified Dandy criteria (Table 4)
    2. Age 18 to <64 years at time of consent
    3. 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)
    4. Presence of bilateral papilledema
    5. 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:

      • Pulse synchronous tinnitus
      • Cranial nerve VI palsy
      • Echography for disc drusen negative and no other disc anomalies mimicking disc edema present
      • Magnetic Resonance Venography (MRV) with lateral sinus collapse/stenosis, partially empty sella turcica on coronal or sagittal views of MRI, and optic nerve sheaths with filled out CSF spaces next to the globe on T2 weighted axial MRI scans If the patient was treated with intracranial pressure lowering agents (e.g., acetazolamide) prior to obtaining a lumbar puncture, the agent(s) must be discontinued for at least 24 hours prior to performing the diagnostic lumbar puncture.
    6. At least one eye meeting all eligible eye inclusion criteria and no exclusion criteria.
    7. Able to provide informed consent
    8. Investigator believes participant is a good candidate for the study, including the probability of returning for follow-up.
  • Eye-Level Eligibility Criteria Subjects must have at least one eye meeting all of the inclusion criteria and none of the exclusion criteria.

If both eyes meet eligibility criteria at the baseline examination, both will be included in the primary outcome analysis.

Inclusion

  1. Visual field loss meeting the following criteria based on two full threshold 24-2 size V tests reviewed by the VFRC:

    • PMD from -6 decibel (dB) to -27 dB
    • Reproducible visual loss present on automated perimetry including no more than 15% false positive response
  2. Visual acuity better than 20/200 (39 or more letters correct)

Exclusion Criteria:

  • Subject Exclusion Criteria Exclusion Criteria

    1. 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.

      If individual discontinued acetazolamide in the past due to side effects, individual is only eligible if investigator believes that the individual is likely to tolerate acetazolamide, as it will be prescribed in the study.

    2. 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.
    3. Treatment with topiramate within two months and average cumulative dosage for the preceding month of more than 700 mg per week
    4. Previous surgery for IIH, including ONSF, CSF shunting, subtemporal decompression, or venous sinus stenting; gastric surgery for obesity is allowed
    5. Abnormalities on neurologic examination except for papilledema and its related visual loss or cranial nerve VI to VII paresis; if other abnormalities are present, the patient will need to be discussed with the Study Director (SD) for study entry.
    6. Abnormal CT or MRI scan (intracranial mass, hydrocephalus, dural sinus thrombus, or arteriovenous malformation) other than findings known to occur with increased intracranial pressure. Abnormalities on MRI that are not known to cause increased intracranial pressure are acceptable.
    7. Abnormal CSF contents: increased cells: > 8 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 white blood cell count (WBC) after correction is 8 cells/mm3 or less - see Manual of Procedures (MOP) for calculation. If > 8 cells or > 45mg% in CSF protein are documented in the CSF or calculated after conversion from a traumatic lumbar puncture, the patient can be discussed with the Study Director for possible inclusion.)
    8. Abnormal blood work-up indicating a medical or systemic condition associated with raised intracranial pressure
    9. Diabetes mellitus with diabetic retinopathy
    10. Ingestion of a drug or substance, or presence of a disorder, that has been associated with increased intracranial pressure within 2 months of diagnosis, such as lithium, vitamin A related products (e.g., Retin-A), or various cyclines (see MOP for conditions and drugs)
    11. Laboratory test results showing severe anemia, leukopenia or thrombocytopenia, renal failure, or hepatic disease, based on the Site Investigator's judgment
    12. Other condition requiring continued use of oral, I.V. or injectable steroids (nasal, inhaled, or topical steroids are allowed since the systemic effects are small). Patients with a condition that resulted in recent or current use of steroids but may be safely tapered off will be handled on a case-by-case basis after discussion with Study Director/co-Director. See Manual of Procedures (MOP) for details.
    13. Presence of a medical condition that would contraindicate use of acetazolamide or furosemide or significantly increase surgical risk
    14. Pregnancy or unwillingness for a subject of childbearing potential to use contraception during the first 6 months of the study Women of childbearing potential must use an acceptable form of birth control during the first 6 months of the study. Acceptable forms include oral contraceptives, transdermal contraceptives, diaphragm, intrauterine devices (IUDs), condoms with spermicide, documented surgical sterilization of either the subject or their partner, or abstinence.
    15. Presence of a physical, mental, or social condition likely to affect follow-up (drug addiction, terminal illness, no telephone, homeless)
    16. Anticipation of a move from the site area within six months and unwillingness to return for follow-up at a SIGHT study site
    17. Allergy to pupil dilating drops or narrow angles precluding safe dilation
    18. Presence of a condition that contraindicates general anesthesia
    19. Participation in an investigational trial within 30 days of enrollment that involved treatment with any systemic drug therapy or therapy that affects the eligible eye(s)
  • Eye Level Exclusion Criteria Exclusion

    1. Intraocular pressure currently >28 mm Hg or >30 mm Hg at any time in the past
    2. Refractive error of more than -6.00 or more than +6.00 sphere or more than 3.00 cylinder with the following exceptions:

      • Eyes with more than 6.00 D of myopia but less than 8.00 D of myopia are eligible if: 1) there are no abnormalities on ophthalmoscopy 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 individual will wear a contact lens for all perimetry examinations with the appropriate correction.
      • Eyes with more than 6.00 D of hyperopia but less than 8.00 D of hyperopia 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 Photographic Reading Center (PRC) Director (or his designate), and 2) the individual will wear a contact lens for all perimetry examinations with the appropriate correction (which can be corrected for perimetry or with the patient's own contact lens with over correction by lens at the perimeter).

      Note: Refractive error exclusion and exceptions refer to sphere not spherical equivalent, with cylinder expressed in plus format.

    3. Other disorders causing visual loss except for refractive error and amblyopia, including cells in the vitreous or iritis
    4. Large optic disc drusen on exam or known in previous history (small drusen of the disc can occur with longstanding papilledema and are allowed if not so numerous that investigator determines they are contributing to vision loss)

Sites / Locations

  • University of Southern California
  • NeuroEyeOrbit Institute
  • Stanford University
  • University of Colorado - Anschutz Medical Campus
  • The Eye Care Group
  • University of Miami
  • Northwestern Medicine
  • University of Illinois at Chicago
  • University of Iowa
  • University of Kansas School of Medicine
  • University of Kentucky
  • Johns Hopkins University School of Medicine
  • Bethesda Neurology, LLC
  • Brigham and Women's Hospital
  • University of Minnesota
  • Mayo Clinic
  • Washington University in St. Louis
  • Saint Louis University
  • University of Nebraska Medical Center
  • State University of New York at Stony Brook
  • New York Eye & Ear Infirmary of Mount Sinai
  • New York University School of Medicine
  • University of Rochester
  • Ohio Neuro-Ophthalmology, Orbital Disease and Oculoplastics
  • Dean McGee Eye Institute
  • University of Pennsylvania
  • Vanderbilt University Medical Center
  • Neuro-Eye Clinical Trials-Houston
  • University of Utah
  • University of Virginia
  • Virginia Commonwealth University
  • Swedish Medical Center
  • University of Wisconsin
  • University of Calgary
  • Sunnybrook Health Science Center
  • Rivera, Enrique J

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Acetazolamide including Diet

Optic Nerve Sheath Fenestration

Ventriculoperitoneal CSF Shunting

Arm Description

Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol). Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet.

Acetazolamide including Diet plus Optic Nerve Sheath Fenestration (ONSF) Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol). Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet. ONSF performed by qualified, certified orbital surgeon using either a medial or supero-medial lid crease approach. ONSF will be performed in one or both eyes, depending on criteria.

Acetazolamide including Diet plus Ventriculoperitoneal CSF Shunting (VPS) Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol). Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet. VPS performed by qualified, certified neurosurgeon using a frameless image-guided stereotactic system and positioning a shunt catheter in the lateral ventricle of the cerebral hemisphere not associated with speech. The catheter will be connected to an adjustable valve, and a distal shunt system will be placed in the peritoneal cavity.

Outcomes

Primary Outcome Measures

Perimetric Mean Deviation (PMD)
Change from baseline to first of Month 6 (Week 26) or time of treatment failure in PMD (perimetric mean deviation) in eligible eye(s) with the size V stimulus

Secondary Outcome Measures

Treatment Failure
Time from randomization to treatment failure
Cerebrospinal Fluid (CSF) Opening Pressure
Change in CSF opening pressure measurement by lumbar puncture
Papilledema Grade
Change in papilledema grade
OCT Retinal Nerve Fiber Layer Thickness
Change in retinal nerve fiber layer thickness
OCT Total Retinal Thickness
Change in total retinal thickness
Visual Acuity (VA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Change in VA scores, determined by baseline VA of better than 20/200 (39 or more letters correct) and worsening indicated by less correct letters
Quality of Life (QoL) 36 Item Short Form Health Survey (SF-36v2)
Changes in QoL as measured by responses
Quality of Life (QoL) Visual Function Questionnaire (VFQ-25)
Changes in QoL as measured by responses
Quality of Life (QoL) 10-item Neuro-ophthalmic Supplement to the VFQ-25
Changes in QoL as measured by responses

Full Information

First Posted
April 10, 2018
Last Updated
May 20, 2022
Sponsor
Jaeb Center for Health Research
Collaborators
National Eye Institute (NEI), University of Iowa, Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT03501966
Brief Title
Surgical Idiopathic Intracranial Hypertension Treatment Trial
Acronym
SIGHT
Official Title
Randomized Trial of Medical Therapy (MT) vs. MT Plus Optic Nerve Sheath Fenestration vs. MT Plus Ventriculoperitoneal Cerebrospinal Fluid Shunting in Subjects With Idiopathic Intracranial Hypertension and Moderate to Severe Visual Loss
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Terminated
Why Stopped
Low enrollment
Study Start Date
February 6, 2019 (Actual)
Primary Completion Date
August 28, 2019 (Actual)
Study Completion Date
August 28, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jaeb Center for Health Research
Collaborators
National Eye Institute (NEI), University of Iowa, Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
After signing the informed consent form, potential subjects will be assessed for eligibility, including eliciting medical and neurologic history, measurement of best-corrected visual acuity, visual field testing, ophthalmoscopy with optic disc edema grading, physical examination, and Optical Coherence Tomography (OCT). Questionnaires will be completed. Blood will be drawn for complete blood count (CBC), electrolytes, liver function tests, renal function tests, amylase if not done as part of routine care within 4 weeks and a pregnancy test will be performed (women of childbearing potential). Two visual field examinations using a size V stimulus will need to be performed at the Screening/Baseline Visit. The size V fields will be sent to the Visual Field Reading Center (VFRC) to confirm eligibility or determine that testing must be repeated for the subject. Eligible individuals will be randomly assigned with equal allocation to one of 3 treatment groups: (1) medical therapy, (2) medical therapy plus ONSF, or (3) medical therapy plus VPS. Acetazolamide should be started on the day of randomization. Surgery should be performed as soon as possible, ideally within 3 days of randomization, but not more than 7 days. Medical therapy will consist of a low sodium weight loss diet and acetazolamide with or without furosemide. Treatment will start with acetazolamide 2 grams per day, with the dose increased as tolerated up to 4 grams per day. If there is no clinical improvement after 2 weeks of maximal dosage of acetazolamide, furosemide will be started at a dose of 40 mg per day (along with potassium) and titrated up to 160-200 mg per day. Pharmacotherapy will be tapered when there is improvement in the papilledema grade, substantial improvement in the PMD and improvement in symptoms or when there is a safety concern. The primary outcome is measured at the first of 6 months (26 weeks) or time of treatment failure. During the randomized trial, follow-up visits will occur after weeks 4, 8, 16, and 26 (± 7 days). Safety visits will occur after weeks 1 and 2 (± 4 days). Additional office visits may occur as needed. Phone contacts will occur at 12 and 20 weeks (±7 days). After the 6-month primary outcome visit, subjects will transition to the Treatment Failure Identification Phase for up to 3 years. Ongoing treatment will continue following the guidelines for the first six months as long as treatment failure criteria are not met at which time treatment will be at the discretion of the Site Investigator. Investigators are urged to employ treatments from another arm of the study before other treatments under these circumstances.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Intracranial Hypertension
Keywords
headache, idiopathic intracranial hypertension (IIH), shunt, fenestration, acetazolamide, visual loss, diamox

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Subjects will be randomly assigned with equal allocation to one of the three treatment groups. Using a permuted block design, randomization will be stratified by PMD (average of 2 size V stimulus tests) in the eligible eye(s) (-6 dB to >-12 dB; -12 dB to >-20 dB; -20 dB to -27 dB). If a subject has two eligible eyes, the average PMD of the two eyes will be used for stratification.
Masking
Outcomes Assessor
Masking Description
Partially-masked technicians for perimetry, fundus photos, OCT, and refraction/ visual acuity
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Acetazolamide including Diet
Arm Type
Active Comparator
Arm Description
Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol). Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet.
Arm Title
Optic Nerve Sheath Fenestration
Arm Type
Active Comparator
Arm Description
Acetazolamide including Diet plus Optic Nerve Sheath Fenestration (ONSF) Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol). Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet. ONSF performed by qualified, certified orbital surgeon using either a medial or supero-medial lid crease approach. ONSF will be performed in one or both eyes, depending on criteria.
Arm Title
Ventriculoperitoneal CSF Shunting
Arm Type
Active Comparator
Arm Description
Acetazolamide including Diet plus Ventriculoperitoneal CSF Shunting (VPS) Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol). Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet. VPS performed by qualified, certified neurosurgeon using a frameless image-guided stereotactic system and positioning a shunt catheter in the lateral ventricle of the cerebral hemisphere not associated with speech. The catheter will be connected to an adjustable valve, and a distal shunt system will be placed in the peritoneal cavity.
Intervention Type
Drug
Intervention Name(s)
Acetazolamide
Other Intervention Name(s)
Diamox, water pill, diuretic
Intervention Description
Medical therapy including diet
Intervention Type
Procedure
Intervention Name(s)
Optic Nerve Sheath Fenestration
Other Intervention Name(s)
ONSF
Intervention Description
Medical therapy including diet + optic nerve sheath fenestration
Intervention Type
Procedure
Intervention Name(s)
Ventriculoperitoneal CSF Shunting
Other Intervention Name(s)
VPS, CSF Shunt Surgery
Intervention Description
Medical therapy including diet + ventriculoperitoneal CSF Shunting
Primary Outcome Measure Information:
Title
Perimetric Mean Deviation (PMD)
Description
Change from baseline to first of Month 6 (Week 26) or time of treatment failure in PMD (perimetric mean deviation) in eligible eye(s) with the size V stimulus
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Treatment Failure
Description
Time from randomization to treatment failure
Time Frame
up to 3 years
Title
Cerebrospinal Fluid (CSF) Opening Pressure
Description
Change in CSF opening pressure measurement by lumbar puncture
Time Frame
6 months
Title
Papilledema Grade
Description
Change in papilledema grade
Time Frame
6 months
Title
OCT Retinal Nerve Fiber Layer Thickness
Description
Change in retinal nerve fiber layer thickness
Time Frame
6 months
Title
OCT Total Retinal Thickness
Description
Change in total retinal thickness
Time Frame
6 months
Title
Visual Acuity (VA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Chart
Description
Change in VA scores, determined by baseline VA of better than 20/200 (39 or more letters correct) and worsening indicated by less correct letters
Time Frame
6 months
Title
Quality of Life (QoL) 36 Item Short Form Health Survey (SF-36v2)
Description
Changes in QoL as measured by responses
Time Frame
6 months
Title
Quality of Life (QoL) Visual Function Questionnaire (VFQ-25)
Description
Changes in QoL as measured by responses
Time Frame
6 months
Title
Quality of Life (QoL) 10-item Neuro-ophthalmic Supplement to the VFQ-25
Description
Changes in QoL as measured by responses
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject Eligibility Criteria 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: Pulse synchronous tinnitus Cranial nerve VI palsy Echography for disc drusen negative and no other disc anomalies mimicking disc edema present Magnetic Resonance Venography (MRV) with lateral sinus collapse/stenosis, partially empty sella turcica on coronal or sagittal views of MRI, and optic nerve sheaths with filled out CSF spaces next to the globe on T2 weighted axial MRI scans If the patient was treated with intracranial pressure lowering agents (e.g., acetazolamide) prior to obtaining a lumbar puncture, the agent(s) must be discontinued for at least 24 hours prior to performing the diagnostic lumbar puncture. At least one eye meeting all eligible eye inclusion criteria and no 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. Eye-Level Eligibility Criteria Subjects must have at least one eye meeting all of the inclusion criteria and none of the exclusion criteria. If both eyes meet eligibility criteria at the baseline examination, both will be included in the primary outcome analysis. Inclusion Visual field loss meeting the following criteria based on two full threshold 24-2 size V tests reviewed by the VFRC: PMD from -6 decibel (dB) to -27 dB Reproducible visual loss present on automated perimetry including no more than 15% false positive response Visual acuity better than 20/200 (39 or more letters correct) Exclusion Criteria: Subject Exclusion Criteria Exclusion Criteria 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. If individual discontinued acetazolamide in the past due to side effects, individual is only eligible if investigator believes that the individual is likely to tolerate acetazolamide, as it will be prescribed in the study. 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 Abnormalities on neurologic examination except for papilledema and its related visual loss or cranial nerve VI to VII paresis; if other abnormalities are present, the patient will need to be discussed with the Study Director (SD) for study entry. Abnormal CT or MRI scan (intracranial mass, hydrocephalus, dural sinus thrombus, or arteriovenous malformation) other than findings known to occur with increased intracranial pressure. Abnormalities on MRI that are not known to cause increased intracranial pressure are acceptable. Abnormal CSF contents: increased cells: > 8 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 white blood cell count (WBC) after correction is 8 cells/mm3 or less - see Manual of Procedures (MOP) for calculation. If > 8 cells or > 45mg% in CSF protein are documented in the CSF or calculated after conversion from a traumatic lumbar puncture, the patient can be discussed with the Study Director for possible inclusion.) Abnormal blood work-up indicating a medical or systemic condition associated with raised intracranial pressure Diabetes mellitus with diabetic retinopathy Ingestion of a drug or substance, or presence of a disorder, that has been associated with increased intracranial pressure within 2 months of diagnosis, such as lithium, vitamin A related products (e.g., Retin-A), or various cyclines (see MOP for conditions and drugs) Laboratory test results showing severe anemia, leukopenia or thrombocytopenia, renal failure, or hepatic disease, based on the Site Investigator's judgment Other condition requiring continued use of oral, I.V. or injectable steroids (nasal, inhaled, or topical steroids are allowed since the systemic effects are small). Patients with a condition that resulted in recent or current use of steroids but may be safely tapered off will be handled on a case-by-case basis after discussion with Study Director/co-Director. See Manual of Procedures (MOP) for details. Presence of a medical condition that would contraindicate use of acetazolamide or furosemide or significantly increase surgical risk Pregnancy or unwillingness for a subject of childbearing potential to use contraception during the first 6 months of the study Women of childbearing potential must use an acceptable form of birth control during the first 6 months of the study. Acceptable forms include oral contraceptives, transdermal contraceptives, diaphragm, intrauterine devices (IUDs), condoms with spermicide, documented surgical sterilization of either the subject or their partner, or abstinence. 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 at a SIGHT study site Allergy to pupil dilating drops or narrow angles precluding safe dilation Presence of a condition that contraindicates general anesthesia Participation in an investigational trial within 30 days of enrollment that involved treatment with any systemic drug therapy or therapy that affects the eligible eye(s) Eye Level Exclusion Criteria Exclusion Intraocular pressure currently >28 mm Hg or >30 mm Hg at any time in the past Refractive error of more than -6.00 or more than +6.00 sphere or more than 3.00 cylinder with the following exceptions: Eyes with more than 6.00 D of myopia but less than 8.00 D of myopia are eligible if: 1) there are no abnormalities on ophthalmoscopy 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 individual will wear a contact lens for all perimetry examinations with the appropriate correction. Eyes with more than 6.00 D of hyperopia but less than 8.00 D of hyperopia 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 Photographic Reading Center (PRC) Director (or his designate), and 2) the individual will wear a contact lens for all perimetry examinations with the appropriate correction (which can be corrected for perimetry or with the patient's own contact lens with over correction by lens at the perimeter). Note: Refractive error exclusion and exceptions refer to sphere not spherical equivalent, with cylinder expressed in plus format. Other disorders causing visual loss except for refractive error and amblyopia, including cells in the vitreous or iritis Large optic disc drusen on exam or known in previous history (small drusen of the disc can occur with longstanding papilledema and are allowed if not so numerous that investigator determines they are contributing to vision loss)
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 Southern California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
NeuroEyeOrbit Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94303
Country
United States
Facility Name
University of Colorado - Anschutz Medical Campus
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
The Eye Care Group
City
Orange
State/Province
Connecticut
ZIP/Postal Code
06477
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Northwestern Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas School of Medicine
City
Prairie Village
State/Province
Kansas
ZIP/Postal Code
64134
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Bethesda Neurology, LLC
City
North Bethesda
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
36110
Country
United States
Facility Name
Saint Louis University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
State University of New York at Stony Brook
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
New York Eye & Ear Infirmary of Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Ohio Neuro-Ophthalmology, Orbital Disease and Oculoplastics
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Dean McGee Eye Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Neuro-Eye Clinical Trials-Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77005
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22904
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University of Wisconsin
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 1P9
Country
Canada
Facility Name
Sunnybrook Health Science Center
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Rivera, Enrique J
City
Bayamón
ZIP/Postal Code
00961
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

Surgical Idiopathic Intracranial Hypertension Treatment Trial

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