Evidence map›Paper›PMID 26198807›Full record

Trial reportOphthalmology2015

Papilledema Outcomes from the Optical Coherence Tomography Substudy of the Idiopathic Intracranial Hypertension Treatment Trial.

Optical Coherence Tomography Substudy Committee, NORDIC Idiopathic Intracranial Hypertension Study Group

Open access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Ophthalmology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 34 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
34citing papers in PubMed, 1 pooled it
4.9field-weighted citation impact, top 5% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

34 citing papers in PubMed, 1 synthesis or guideline pooled it, 85 citations in OpenAlex.

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  16. Neuro-ophthalmic features of patients with spontaneous cerebrospinal fluid leaks.Medical hypothesis, discovery & innovation ophthalmology journal · 2023
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  17. Observational
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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

2 authors at 2 institutions in 2 countries.

Optical Coherence Tomography Substudy Committee
NORDIC Idiopathic Intracranial Hypertension Study Group
Eye Center · SASt. Luke's-Roosevelt Hospital Center · 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 3U10EY017281-01A1S1NEI NIH HHS U10 EY017281NEI NIH HHS U10 EY017281-01A1NEI NIH HHS U10 EY017387NEI NIH HHS U10 EY017387-01A1
6 · The paper itself

Abstract

purposeTo assess treatment efficacy using spectral-domain (SD) optical coherence tomography (OCT) measurements of papilledema in the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT), which evaluated the effects of acetazolamide and weight management and of placebo and weight management in eyes with mild visual loss.

designRandomized double-masked control clinical trial of acetazolamide plus weight management compared with placebo plus weight management in subjects with mild visual field loss and previously untreated idiopathic intracranial hypertension (IIH).

participantsEighty-nine (43 acetazolamide treated, 46 placebo treated) of 165 subjects meeting IIHTT entry criteria.

methodsSubjects underwent perimetry, papilledema grading (Frisén method), high- and low-contrast visual acuity, and SD OCT imaging at study entry and 3 and 6 months. Study eye results (worse perimetric mean deviation [PMD]) were used for most analyses.

main outcome measuresRetinal nerve fiber layer (RNFL) thickness, total retinal thickness (TRT), optic nerve (ONH) volume, and retinal ganglion cell layer (RGCL) measurements derived using 3-dimensional segmentation.

resultsStudy entry OCT values were similar in both treatment groups. At 6 months, the acetazolamide group had greater reduction than the placebo group for RNFL thickness (175 μm vs. 89 μm; P = 0.001), TRT (220 μm vs. 113 μm; P = 0.001), and ONH volume (4.9 mm(3) vs. 2.1 mm(3); P = 0.001). The RNFL thickness (P = 0.01), TRT (P = 0.003), and ONH volume (P = 0.002) measurements also showed smaller increases in subjects who lost 6% or more of study entry weight. The acetazolamide (3.6 μm) and placebo (2.1 μm) groups showed minor RGCL thinning (P = 0.06). The RNFL thickness, TRT, and ONH volume measurements showed moderate correlations (r = 0.48-0.59; P ≤ 0.0001) with Frisén grade. The 14 eyes with RGCL thickness less than the fifth percentile of controls had worse PMD (P = 0.001) than study eyes with RGCL in the fifth percentile or more.

conclusionsIn IIH, acetazolamide and weight loss effectively improve RNFL thickness, TRT, and ONH volume swelling measurements resulting from papilledema. In contrast to the strong correlation at baseline, OCT measures at 6 months show only moderate correlations with papilledema grade.

Indexed as

AcetazolamideCarbonic Anhydrase InhibitorsDouble-Blind MethodFollow-Up StudiesHumansNerve FibersPapilledemaProspective StudiesPseudotumor CerebriRetinaRetinal Ganglion CellsTomography, Optical CoherenceTreatment OutcomeVisual Field TestsWeight LossAcetazolamideCarbonic Anhydrase Inhibitors

Identifiers

PMID26198807
PMCPMC4549202
OpenAlexW1544779550

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.