Evidence map›Paper›PMID 26934136›Full record

Trial reportInvestigative ophthalmology & visual science2016

Visual Field Outcomes for the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT).

Michael Wall, Chris A Johnson, Kimberly E Cello, K D Zamba, Michael P McDermott, John L Keltner, NORDIC Idiopathic Intracranial Hypertension Study Group

2 registry-linked trialsAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Investigative ophthalmology & visual science, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 23 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
23citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01003639 phase2 / phase3completednot on this map

A Multicenter, Double-blind, Randomized, Placebo-controlled Study of Weight-Reduction and/or Low Sodium Diet Plus Acetazolamide vs Diet Plus Placebo in Subjects With Idiopathic Intracranial Hypertension With Mild Visual Loss

TypeinterventionalSponsorSt. Luke's-Roosevelt Hospital CenterRan2010 to 2014Enrolled165ConditionsIdiopathic Intracranial HypertensionArmsAcetazolamide, Placebo, Formal weight loss counselling program
NCT06913712 recruitingnot on this mapstarted 2024, after this paper: background citation

Evolution of Body Mass Index in Idiopathic Intracranial Hypertension and Its Relationship With the Response to Treatment. Retrospective and Prospective Study

TypeobservationalSponsorUniversity of ValenciaRan2024 to 2028Enrolled25ConditionsIdiopathic Intracranial Hypertension (IIH)ArmsWeight loss without pharmacotherapy
3 · Its place in the literature

Who cites it

23 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
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  9. Interpretation of the Visual Field in Neuro-ophthalmic Disorders.Current neurology and neuroscience reports · 2024
    Review
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  12. Management of recurrent cerebrospinal fluid leak, current practices and open challenges. A systematic literature review.Acta otorhinolaryngologica Italica : organo ufficiale della Societa italiana di otorinolaringologia e chirurgia cervico-facciale · 2023
    Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

7 authors.

Michael WallDepartment of Neurology, University of Iowa, Iowa City, Iowa, United States 2Department of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, Iowa, United States.
Chris A JohnsonDepartment of Ophthalmology and Visual Sciences, University of Iowa, Iowa City, Iowa, United States.
Kimberly E CelloDepartment of Ophthalmology and Vision Science, University of California Davis, Davis, California, United States.
K D ZambaDepartment of Biostatistics, College of Public Health, University of Iowa, Iowa City, Iowa, United States.
Michael P McDermottDepartments of Biostatistics and Computational Biology and Neurology, University of Rochester Medical Center, Rochester, New York, United States.
John L KeltnerDepartment of Ophthalmology and Vision Science, University of California Davis, Davis, California, United States 6Department of Neurology and Neurological Surgery, University of California Davis, Davis, California, United States.
NORDIC Idiopathic Intracranial Hypertension Study Group

Funding

Neuro-Ophthalmology Research Disease Investigator Consortium (NORDIC) NetworkU10EY017281 · NEI · ST. LUKE'S-ROOSEVELT INST FOR HLTH SCIS · PI KUPERSMITH, MARK J · 2009 to 2014
$10.2M
NEI NIH HHS 1U10EY017281-01A1NEI NIH HHS U10 EY017281
6 · The paper itself

Abstract

purposeThe Idiopathic Intracranial Hypertension Treatment Trial (IIHTT) showed that acetazolamide provided a modest, significant improvement in mean deviation (MD). Here, we further analyze visual field changes over the 6-month study period.

methodsOf 165 subjects with mild visual loss in the IIHTT, 125 had perimetry at baseline and 6 months. We evaluated pointwise linear regression of visual sensitivity versus time to classify test locations in the worst MD (study) eye as improving or not; pointwise changes from baseline to month 6 in decibels; and clinical consensus of change from baseline to 6 months.

resultsThe average study eye had 36 of 52 test locations with improving sensitivity over 6 months using pointwise linear regression, but differences between the acetazolamide and placebo groups were not significant. Pointwise results mostly improved in both treatment groups with the magnitude of the mean change within groups greatest and statistically significant around the blind spot and the nasal area, especially in the acetazolamide group. The consensus classification of visual field change from baseline to 6 months in the study eye yielded percentages (acetazolamide, placebo) of 7.2% and 17.5% worse, 35.1% and 31.7% with no change, and 56.1% and 50.8% improved; group differences were not statistically significant.

conclusionsIn the IIHTT, compared to the placebo group, the acetazolamide group had a significant pointwise improvement in visual field function, particularly in the nasal and pericecal areas; the latter is likely due to reduction in blind spot size related to improvement in papilledema. (ClinicalTrials.gov number, NCT01003639.).

Indexed as

AcetazolamideAdolescentAdultCarbonic Anhydrase InhibitorsFemaleFollow-Up StudiesHumansMaleMiddle AgedPseudotumor CerebriTime FactorsTreatment OutcomeVisual AcuityVisual FieldsVisual Field TestsYoung AdultAcetazolamideCarbonic Anhydrase Inhibitors

Identifiers

PMID26934136
PMCPMC4777274

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.