Trial · NCT03501966
Surgical Idiopathic Intracranial Hypertension Treatment Trial
NCT03501966, Phase 3, Terminated, Jaeb Center for Health Research; results first posted 2022-06-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Surgical Idiopathic Intracranial Hypertension Treatment Trial. Trials, record NCT03501966. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03501966
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Surgical Idiopathic Intracranial Hypertension Treatment Trial
- NCT number
- NCT03501966
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 7 participants, actual
- Lead sponsor
- Jaeb Center for Health Research
- Conditions
- Idiopathic Intracranial Hypertension
- Interventions
- Acetazolamide, Optic Nerve Sheath Fenestration, Ventriculoperitoneal CSF Shunting
- First posted
- 2018-04-18
- Last updated
- 2022-06-16
- Results first posted
- 2022-06-16
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Perimetric Mean Deviation (PMD) | 6 months | 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 | Treatment Failure | up to 3 years | Time from randomization to treatment failure |
| Secondary | Cerebrospinal Fluid (CSF) Opening Pressure | 6 months | Change in CSF opening pressure measurement by lumbar puncture |
| Secondary | Papilledema Grade | 6 months | Change in papilledema grade |
| Secondary | OCT Retinal Nerve Fiber Layer Thickness | 6 months | Change in retinal nerve fiber layer thickness |
| Secondary | OCT Total Retinal Thickness | 6 months | Change in total retinal thickness |
| Secondary | Visual Acuity (VA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Chart | 6 months | 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 |
| Secondary | Quality of Life (QoL) 36 Item Short Form Health Survey (SF-36v2) | 6 months | Changes in QoL as measured by responses |
| Secondary | Quality of Life (QoL) Visual Function Questionnaire (VFQ-25) | 6 months | Changes in QoL as measured by responses |
| Secondary | Quality of Life (QoL) 10-item Neuro-ophthalmic Supplement to the VFQ-25 | 6 months | Changes in QoL as measured by responses |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Perimetric Mean Deviation (PMD) | 6 months | No data collected, study terminated due to poor enrollment prior to any data collection. | ||
| SECONDARY | Treatment Failure | up to 3 years | No data collected, study terminated due to poor enrollment prior to any data collection. | ||
| SECONDARY | Cerebrospinal Fluid (CSF) Opening Pressure | 6 months | No data collected, study terminated due to poor enrollment prior to any data collection. | ||
| SECONDARY | Papilledema Grade | 6 months | No data collected, study terminated due to poor enrollment prior to any data collection. | ||
| SECONDARY | OCT Retinal Nerve Fiber Layer Thickness | 6 months | No data collected, study terminated due to poor enrollment prior to any data collection. | ||
| SECONDARY | OCT Total Retinal Thickness | 6 months | No data collected, study terminated due to poor enrollment prior to any data collection. | ||
| SECONDARY | Visual Acuity (VA) Using Early Treatment Diabetic Retinopathy Study (ETDRS) Chart | 6 months | No data collected, study terminated due to poor enrollment prior to any data collection. | ||
| SECONDARY | Quality of Life (QoL) 36 Item Short Form Health Survey (SF-36v2) | 6 months | No data collected, study terminated due to poor enrollment prior to any data collection. | ||
| SECONDARY | Quality of Life (QoL) Visual Function Questionnaire (VFQ-25) | 6 months | No data collected, study terminated due to poor enrollment prior to any data collection. | ||
| SECONDARY | Quality of Life (QoL) 10-item Neuro-ophthalmic Supplement to the VFQ-25 | 6 months | No data collected, study terminated due to poor enrollment prior to any data collection. |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Acetazolamide Including Diet | 2 | |
| Overall Study | STARTED | Optic Nerve Sheath Fenestration | 2 | |
| Overall Study | STARTED | Ventriculoperitoneal CSF Shunting | 3 | |
| Overall Study | COMPLETED | Acetazolamide Including Diet | 0 | |
| Overall Study | COMPLETED | Optic Nerve Sheath Fenestration | 0 | |
| Overall Study | COMPLETED | Ventriculoperitoneal CSF Shunting | 0 | |
| Overall Study | NOT COMPLETED | Acetazolamide Including Diet | 2 | |
| Overall Study | NOT COMPLETED | Optic Nerve Sheath Fenestration | 2 | |
| Overall Study | NOT COMPLETED | Ventriculoperitoneal CSF Shunting | 3 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Acetazolamide Including Diet | 0 | 2 |
| Total, all-cause mortality | Optic Nerve Sheath Fenestration | 0 | 2 |
| Total, all-cause mortality | Ventriculoperitoneal CSF Shunting | 0 | 3 |
| Total, other adverse events | Acetazolamide Including Diet | 0 | 2 |
| Total, other adverse events | Optic Nerve Sheath Fenestration | 0 | 2 |
| Total, other adverse events | Ventriculoperitoneal CSF Shunting | 0 | 3 |
| Total, serious adverse events | Acetazolamide Including Diet | 0 | 2 |
| Total, serious adverse events | Optic Nerve Sheath Fenestration | 0 | 2 |
| Total, serious adverse events | Ventriculoperitoneal CSF Shunting | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| U10EY025990 | Surgical IIH Treatment Trial | KUPERSMITH, MARK J | ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI | NATIONAL EYE INSTITUTE | 2017 to 2018 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03501966
GET https://conductscience.org/api/trials/v1/NCT03501966/registered