Ignite Creation Date:
2025-12-24 @ 4:24 PM
Ignite Modification Date:
2026-02-01 @ 2:18 AM
Study NCT ID:
NCT03501966
Status:
TERMINATED
Last Update Posted:
2022-06-16
First Post:
2018-04-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Surgical Idiopathic Intracranial Hypertension Treatment Trial
Sponsor:
Organization:
Raw JSON
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ONSF will be performed in one or both eyes, depending on criteria.\n\nOptic Nerve Sheath Fenestration: Medical therapy including diet + optic nerve sheath fenestration', 'otherNumAtRisk': 2, 'deathsNumAtRisk': 2, 'otherNumAffected': 0, 'seriousNumAtRisk': 2, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ventriculoperitoneal CSF Shunting', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nVPS 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.\n\nVentriculoperitoneal CSF Shunting: Medical therapy including diet + ventriculoperitoneal CSF Shunting', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Perimetric Mean Deviation (PMD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetazolamide Including Diet', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nAcetazolamide: Medical therapy including diet'}, {'id': 'OG001', 'title': 'Optic Nerve Sheath Fenestration', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nONSF 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.\n\nOptic Nerve Sheath Fenestration: Medical therapy including diet + optic nerve sheath fenestration'}, {'id': 'OG002', 'title': 'Ventriculoperitoneal CSF Shunting', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nVPS 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.\n\nVentriculoperitoneal CSF Shunting: Medical therapy including diet + ventriculoperitoneal CSF Shunting'}], 'timeFrame': '6 months', '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', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected, study terminated due to poor enrollment prior to any data collection.'}, {'type': 'SECONDARY', 'title': 'Treatment Failure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetazolamide Including Diet', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nAcetazolamide: Medical therapy including diet'}, {'id': 'OG001', 'title': 'Optic Nerve Sheath Fenestration', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nONSF 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.\n\nOptic Nerve Sheath Fenestration: Medical therapy including diet + optic nerve sheath fenestration'}, {'id': 'OG002', 'title': 'Ventriculoperitoneal CSF Shunting', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nVPS 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.\n\nVentriculoperitoneal CSF Shunting: Medical therapy including diet + ventriculoperitoneal CSF Shunting'}], 'timeFrame': 'up to 3 years', 'description': 'Time from randomization to treatment failure', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected, study terminated due to poor enrollment prior to any data collection.'}, {'type': 'SECONDARY', 'title': 'Cerebrospinal Fluid (CSF) Opening Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetazolamide Including Diet', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nAcetazolamide: Medical therapy including diet'}, {'id': 'OG001', 'title': 'Optic Nerve Sheath Fenestration', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nONSF 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.\n\nOptic Nerve Sheath Fenestration: Medical therapy including diet + optic nerve sheath fenestration'}, {'id': 'OG002', 'title': 'Ventriculoperitoneal CSF Shunting', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nVPS 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.\n\nVentriculoperitoneal CSF Shunting: Medical therapy including diet + ventriculoperitoneal CSF Shunting'}], 'timeFrame': '6 months', 'description': 'Change in CSF opening pressure measurement by lumbar puncture', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected, study terminated due to poor enrollment prior to any data collection.'}, {'type': 'SECONDARY', 'title': 'Papilledema Grade', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetazolamide Including Diet', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nAcetazolamide: Medical therapy including diet'}, {'id': 'OG001', 'title': 'Optic Nerve Sheath Fenestration', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nONSF 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.\n\nOptic Nerve Sheath Fenestration: Medical therapy including diet + optic nerve sheath fenestration'}, {'id': 'OG002', 'title': 'Ventriculoperitoneal CSF Shunting', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nVPS 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.\n\nVentriculoperitoneal CSF Shunting: Medical therapy including diet + ventriculoperitoneal CSF Shunting'}], 'timeFrame': '6 months', 'description': 'Change in papilledema grade', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected, study terminated due to poor enrollment prior to any data collection.'}, {'type': 'SECONDARY', 'title': 'OCT Retinal Nerve Fiber Layer Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetazolamide Including Diet', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nAcetazolamide: Medical therapy including diet'}, {'id': 'OG001', 'title': 'Optic Nerve Sheath Fenestration', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nONSF 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.\n\nOptic Nerve Sheath Fenestration: Medical therapy including diet + optic nerve sheath fenestration'}, {'id': 'OG002', 'title': 'Ventriculoperitoneal CSF Shunting', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nVPS 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.\n\nVentriculoperitoneal CSF Shunting: Medical therapy including diet + ventriculoperitoneal CSF Shunting'}], 'timeFrame': '6 months', 'description': 'Change in retinal nerve fiber layer thickness', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected, study terminated due to poor enrollment prior to any data collection.'}, {'type': 'SECONDARY', 'title': 'OCT Total Retinal Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetazolamide Including Diet', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nAcetazolamide: Medical therapy including diet'}, {'id': 'OG001', 'title': 'Optic Nerve Sheath Fenestration', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nONSF 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.\n\nOptic Nerve Sheath Fenestration: Medical therapy including diet + optic nerve sheath fenestration'}, {'id': 'OG002', 'title': 'Ventriculoperitoneal CSF Shunting', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nVPS 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.\n\nVentriculoperitoneal CSF Shunting: Medical therapy including diet + ventriculoperitoneal CSF Shunting'}], 'timeFrame': '6 months', 'description': 'Change in total retinal thickness', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected, study terminated due to poor enrollment prior to any data collection.'}, {'type': 'SECONDARY', 'title': 'Visual Acuity (VA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Chart', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetazolamide Including Diet', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nAcetazolamide: Medical therapy including diet'}, {'id': 'OG001', 'title': 'Optic Nerve Sheath Fenestration', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nONSF 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.\n\nOptic Nerve Sheath Fenestration: Medical therapy including diet + optic nerve sheath fenestration'}, {'id': 'OG002', 'title': 'Ventriculoperitoneal CSF Shunting', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nVPS 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.\n\nVentriculoperitoneal CSF Shunting: Medical therapy including diet + ventriculoperitoneal CSF Shunting'}], 'timeFrame': '6 months', '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', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected, study terminated due to poor enrollment prior to any data collection.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QoL) 36 Item Short Form Health Survey (SF-36v2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetazolamide Including Diet', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nAcetazolamide: Medical therapy including diet'}, {'id': 'OG001', 'title': 'Optic Nerve Sheath Fenestration', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nONSF 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.\n\nOptic Nerve Sheath Fenestration: Medical therapy including diet + optic nerve sheath fenestration'}, {'id': 'OG002', 'title': 'Ventriculoperitoneal CSF Shunting', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nVPS 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.\n\nVentriculoperitoneal CSF Shunting: Medical therapy including diet + ventriculoperitoneal CSF Shunting'}], 'timeFrame': '6 months', 'description': 'Changes in QoL as measured by responses', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected, study terminated due to poor enrollment prior to any data collection.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QoL) Visual Function Questionnaire (VFQ-25)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetazolamide Including Diet', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nAcetazolamide: Medical therapy including diet'}, {'id': 'OG001', 'title': 'Optic Nerve Sheath Fenestration', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nONSF 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.\n\nOptic Nerve Sheath Fenestration: Medical therapy including diet + optic nerve sheath fenestration'}, {'id': 'OG002', 'title': 'Ventriculoperitoneal CSF Shunting', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nVPS 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.\n\nVentriculoperitoneal CSF Shunting: Medical therapy including diet + ventriculoperitoneal CSF Shunting'}], 'timeFrame': '6 months', 'description': 'Changes in QoL as measured by responses', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected, study terminated due to poor enrollment prior to any data collection.'}, {'type': 'SECONDARY', 'title': 'Quality of Life (QoL) 10-item Neuro-ophthalmic Supplement to the VFQ-25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Acetazolamide Including Diet', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nAcetazolamide: Medical therapy including diet'}, {'id': 'OG001', 'title': 'Optic Nerve Sheath Fenestration', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nONSF 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.\n\nOptic Nerve Sheath Fenestration: Medical therapy including diet + optic nerve sheath fenestration'}, {'id': 'OG002', 'title': 'Ventriculoperitoneal CSF Shunting', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nVPS 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.\n\nVentriculoperitoneal CSF Shunting: Medical therapy including diet + ventriculoperitoneal CSF Shunting'}], 'timeFrame': '6 months', 'description': 'Changes in QoL as measured by responses', 'reportingStatus': 'POSTED', 'populationDescription': 'No data collected, study terminated due to poor enrollment prior to any data collection.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Acetazolamide Including Diet', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nAcetazolamide: Medical therapy including diet'}, {'id': 'FG001', 'title': 'Optic Nerve Sheath Fenestration', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nONSF 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.\n\nOptic Nerve Sheath Fenestration: Medical therapy including diet + optic nerve sheath fenestration'}, {'id': 'FG002', 'title': 'Ventriculoperitoneal CSF Shunting', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nVPS 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.\n\nVentriculoperitoneal CSF Shunting: Medical therapy including diet + ventriculoperitoneal CSF Shunting'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Recruitment began in October 2018 and continued until the study stopped on August 28, 2019.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Acetazolamide Including Diet', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nAcetazolamide: Medical therapy including diet'}, {'id': 'BG001', 'title': 'Optic Nerve Sheath Fenestration', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nONSF 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.\n\nOptic Nerve Sheath Fenestration: Medical therapy including diet + optic nerve sheath fenestration'}, {'id': 'BG002', 'title': 'Ventriculoperitoneal CSF Shunting', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nVPS 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.\n\nVentriculoperitoneal CSF Shunting: Medical therapy including diet + ventriculoperitoneal CSF Shunting'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}]}, {'title': 'Age, Continuous'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Race and Ethnicity Not Collected', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'No data collected, study terminated due to poor enrollment prior to any data collection.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-04-11', 'size': 1509869, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-03-29T15:50', 'hasProtocol': True}, {'date': '2019-01-30', 'size': 372906, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-05-20T09:13', 'hasProtocol': False}, {'date': '2018-10-01', 'size': 296637, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2018-10-05T15:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Partially-masked technicians for perimetry, fundus photos, OCT, and refraction/ visual acuity'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'Low enrollment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-05-20', 'studyFirstSubmitDate': '2018-04-10', 'resultsFirstSubmitDate': '2022-03-29', 'studyFirstSubmitQcDate': '2018-04-17', 'lastUpdatePostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-05-20', 'studyFirstPostDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perimetric Mean Deviation (PMD)', 'timeFrame': '6 months', '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'}], 'secondaryOutcomes': [{'measure': 'Treatment Failure', 'timeFrame': 'up to 3 years', 'description': 'Time from randomization to treatment failure'}, {'measure': 'Cerebrospinal Fluid (CSF) Opening Pressure', 'timeFrame': '6 months', 'description': 'Change in CSF opening pressure measurement by lumbar puncture'}, {'measure': 'Papilledema Grade', 'timeFrame': '6 months', 'description': 'Change in papilledema grade'}, {'measure': 'OCT Retinal Nerve Fiber Layer Thickness', 'timeFrame': '6 months', 'description': 'Change in retinal nerve fiber layer thickness'}, {'measure': 'OCT Total Retinal Thickness', 'timeFrame': '6 months', 'description': 'Change in total retinal thickness'}, {'measure': 'Visual Acuity (VA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Chart', 'timeFrame': '6 months', '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'}, {'measure': 'Quality of Life (QoL) 36 Item Short Form Health Survey (SF-36v2)', 'timeFrame': '6 months', 'description': 'Changes in QoL as measured by responses'}, {'measure': 'Quality of Life (QoL) Visual Function Questionnaire (VFQ-25)', 'timeFrame': '6 months', 'description': 'Changes in QoL as measured by responses'}, {'measure': 'Quality of Life (QoL) 10-item Neuro-ophthalmic Supplement to the VFQ-25', 'timeFrame': '6 months', 'description': 'Changes in QoL as measured by responses'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['headache', 'idiopathic intracranial hypertension (IIH)', 'shunt', 'fenestration', 'acetazolamide', 'visual loss', 'diamox'], 'conditions': ['Idiopathic Intracranial Hypertension']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).\n\nTwo 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.\n\nEligible 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.\n\nMedical 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.\n\nThe 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).\n\nAfter 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '63 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject Eligibility Criteria Inclusion Criteria\n\n 1. Diagnosis of IIH by modified Dandy criteria (Table 4)\n 2. Age 18 to \\<64 years at time of consent\n 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)\n 4. Presence of bilateral papilledema\n 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:\n\n * Pulse synchronous tinnitus\n * Cranial nerve VI palsy\n * Echography for disc drusen negative and no other disc anomalies mimicking disc edema present\n * 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.\n 6. At least one eye meeting all eligible eye inclusion criteria and no exclusion criteria.\n 7. Able to provide informed consent\n 8. Investigator believes participant is a good candidate for the study, including the probability of returning for follow-up.\n* Eye-Level Eligibility Criteria Subjects must have at least one eye meeting all of the inclusion criteria and none of the exclusion criteria.\n\nIf both eyes meet eligibility criteria at the baseline examination, both will be included in the primary outcome analysis.\n\nInclusion\n\n1. Visual field loss meeting the following criteria based on two full threshold 24-2 size V tests reviewed by the VFRC:\n\n * PMD from -6 decibel (dB) to -27 dB\n * Reproducible visual loss present on automated perimetry including no more than 15% false positive response\n2. Visual acuity better than 20/200 (39 or more letters correct)\n\nExclusion Criteria:\n\n* Subject Exclusion Criteria Exclusion Criteria\n\n 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.\n\n 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.\n 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.\n 3. Treatment with topiramate within two months and average cumulative dosage for the preceding month of more than 700 mg per week\n 4. Previous surgery for IIH, including ONSF, CSF shunting, subtemporal decompression, or venous sinus stenting; gastric surgery for obesity is allowed\n 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.\n 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.\n 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.)\n 8. Abnormal blood work-up indicating a medical or systemic condition associated with raised intracranial pressure\n 9. Diabetes mellitus with diabetic retinopathy\n 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)\n 11. Laboratory test results showing severe anemia, leukopenia or thrombocytopenia, renal failure, or hepatic disease, based on the Site Investigator's judgment\n 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.\n 13. Presence of a medical condition that would contraindicate use of acetazolamide or furosemide or significantly increase surgical risk\n 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.\n 15. Presence of a physical, mental, or social condition likely to affect follow-up (drug addiction, terminal illness, no telephone, homeless)\n 16. Anticipation of a move from the site area within six months and unwillingness to return for follow-up at a SIGHT study site\n 17. Allergy to pupil dilating drops or narrow angles precluding safe dilation\n 18. Presence of a condition that contraindicates general anesthesia\n 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)\n* Eye Level Exclusion Criteria Exclusion\n\n 1. Intraocular pressure currently \\>28 mm Hg or \\>30 mm Hg at any time in the past\n 2. Refractive error of more than -6.00 or more than +6.00 sphere or more than 3.00 cylinder with the following exceptions:\n\n * 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.\n * 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).\n\n Note: Refractive error exclusion and exceptions refer to sphere not spherical equivalent, with cylinder expressed in plus format.\n 3. Other disorders causing visual loss except for refractive error and amblyopia, including cells in the vitreous or iritis\n 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)"}, 'identificationModule': {'nctId': 'NCT03501966', 'acronym': 'SIGHT', 'briefTitle': 'Surgical Idiopathic Intracranial Hypertension Treatment Trial', 'organization': {'class': 'OTHER', 'fullName': 'Jaeb Center for Health Research'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'SIGHT'}, 'secondaryIdInfos': [{'id': '1U10EY025990-01A1', 'link': 'https://reporter.nih.gov/quickSearch/1U10EY025990-01A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Acetazolamide including Diet', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.', 'interventionNames': ['Drug: Acetazolamide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Optic Nerve Sheath Fenestration', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nONSF 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.', 'interventionNames': ['Procedure: Optic Nerve Sheath Fenestration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ventriculoperitoneal CSF Shunting', '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).\n\nDietary consultation will include advising subjects to adopt a low sodium weight reduced diet.\n\nVPS 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.', 'interventionNames': ['Procedure: Ventriculoperitoneal CSF Shunting']}], 'interventions': [{'name': 'Acetazolamide', 'type': 'DRUG', 'otherNames': ['Diamox', 'water pill', 'diuretic'], 'description': 'Medical therapy including diet', 'armGroupLabels': ['Acetazolamide including Diet']}, {'name': 'Optic Nerve Sheath Fenestration', 'type': 'PROCEDURE', 'otherNames': ['ONSF'], 'description': 'Medical therapy including diet + optic nerve sheath fenestration', 'armGroupLabels': ['Optic Nerve Sheath Fenestration']}, {'name': 'Ventriculoperitoneal CSF Shunting', 'type': 'PROCEDURE', 'otherNames': ['VPS', 'CSF Shunt Surgery'], 'description': 'Medical therapy including diet + ventriculoperitoneal CSF Shunting', 'armGroupLabels': ['Ventriculoperitoneal CSF Shunting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'University of Southern California', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'NeuroEyeOrbit Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94303', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado - Anschutz Medical Campus', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '06477', 'city': 'Orange', 'state': 'Connecticut', 'country': 'United States', 'facility': 'The Eye Care Group', 'geoPoint': {'lat': 41.27843, 'lon': -73.02566}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '64134', 'city': 'Prairie Village', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas School of Medicine', 'geoPoint': {'lat': 38.99167, 'lon': -94.63357}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20852', 'city': 'North Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Bethesda Neurology, LLC', 'geoPoint': {'lat': 39.04455, 'lon': -77.11887}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '36110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': 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'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '43214', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Neuro-Ophthalmology, Orbital Disease and Oculoplastics', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73104', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Dean McGee Eye Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77005', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 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