Evidence map›Paper›PMID 26024112›Full record

Trial reportInvestigative ophthalmology & visual science2015

Photographic Reading Center of the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT): Methods and Baseline Results.

William S Fischer, Michael Wall, Michael P McDermott, Mark J Kupersmith, Steven E Feldon, NORDIC Idiopathic Intracranial Hypertension Study Group

Registry-linked trialOpen access · bronzeAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Investigative ophthalmology & visual science, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01003639 (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), which is not on this map. Cited by 22 papers.

0numbers the graph read from it
0cells of the map it votes in
22citing papers in PubMed
1.3field-weighted citation impact, top 20% of its field
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
3 · Its place in the literature

Who cites it

22 citing papers in PubMed, 30 citations in OpenAlex.

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  20. Retinal and Choroidal Folds in Papilledema.Investigative ophthalmology & visual science · 2015
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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

6 authors at 3 institutions in 1 country.

William S FischerDepartment of Ophthalmology Flaum Eye Institute, University of Rochester, Rochester, New York, United States.
Michael WallDepartment of Neurology, University of Iowa, Iowa City, Iowa, United States 3Department of Ophthalmology, University of Iowa, Iowa City, Iowa, United States.
Michael P McDermottCenter for Human Experimental Therapeutics, University of Rochester, Rochester, New York, United States 5Department of Biostatistics and Computational Biology, University of Rochester, Rochester, New York, United States.
Mark J KupersmithMount Sinai Roosevelt Hospital, New York, New York, United States 7New York Eye and Ear Infirmary of Mount Sinai, New York, New York, United States.
Steven E FeldonDepartment of Ophthalmology Flaum Eye Institute, University of Rochester, Rochester, New York, United States.
NORDIC Idiopathic Intracranial Hypertension Study Group
University of Rochester · USSt. Luke's-Roosevelt Hospital Center · USUniversity of Iowa · US

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
Data Coordination and Biostatistics Center for the NORDIC NetworkU10EY017387 · NEI · UNIVERSITY OF ROCHESTER · PI KIEBURTZ, KARL D. · 2009 to 2013
$7.0M
NEI NIH HHS 1U10EY017281-01A1NEI NIH HHS 1U10EY017387-01A1NEI NIH HHS 1U10EY017387-01A1S1NEI NIH HHS 3U10EY017281-01A1S1NEI NIH HHS 3U10EY017281-01A1S2NEI NIH HHS U10 EY017281NEI NIH HHS U10 EY017387
6 · The paper itself

Abstract

purposeTo describe the methods used by the Photographic Reading Center (PRC) of the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT) and to report baseline assessments of papilledema severity in participants.

methodsStereoscopic digital images centered on the optic disc and the macula were collected using certified personnel and photographic equipment. Certification of the camera system included standardization and calibration using a model eye. Lay readers assessed disc photos of all eyes using the Frisén grade and performed quantitative measurements of papilledema. Frisén grades by PRC were compared with site investigator clinical grades. Spearman rank correlations were used to quantify associations among disc features and selected clinical variables.

resultsFrisén grades according to the PRC and site investigator's grades, matched exactly in 48% of the study eyes and 42% of the fellow eyes and within one grade in 94% of the study eyes and 92% of the fellow eyes. Frisén grade was strongly correlated (r > 0.65, P < 0.0001) with quantitative measures of disc area. Cerebrospinal fluid pressure was weakly associated with Frisén grade and disc area determinations (r ≤ 0.31). Neither Frisén grade nor any fundus feature was associated with perimetric mean deviation.

conclusionsIn a prospective clinical trial, lay readers agreed reasonably well with physicians in assessing Frisén grade. Standardization of camera systems enhanced consistency of photographic quality across study sites. Images were affected more by sensors with poor dynamic range than by poor resolution. Frisén grade is highly correlated with quantitative assessment of disc area. (ClinicalTrials.gov number, NCT01003639.).

Indexed as

AdultCerebrospinal Fluid PressureFemaleHumansIntracranial HypertensionMaleMiddle AgedObserver VariationOphthalmoscopyOptic DiskPapilledemaPhotographyProspective StudiesReadingReproducibility of Results

Identifiers

PMID26024112
PMCPMC4453296
OpenAlexW1590591198

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.