Baseline OCT measurements in the idiopathic intracranial hypertension treatment trial, part I: quality control, comparisons, and variability

Optical coherence tomography (OCT) has been used to investigate papilledema in single-site, mostly retrospective studies. We investigated whether spectral-domain OCT (SD-OCT), which provides thickness and volume measurements of the optic nerve head and retina, could reliably demonstrate structural c...

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Bibliographic Details
Published in:Investigative ophthalmology & visual science 2014-12, Vol.55 (12), p.8180-8188
Main Authors: Auinger, Peggy, Durbin, Mary, Feldon, Steven, Garvin, Mona, Kardon, Randy, Keltner, John, Kupersmith, Mark, Sibony, Patrick, Plumb, Kim, Wang, Jui-Kai, Werner, John S
Format: Article
Language:English
Subjects:
Adult
Algorithms
Case-Control Studies
Female
Humans
Intracranial Hypertension - complications
Intracranial Hypertension - drug therapy
Macula Lutea - pathology
Male
Middle Aged
Nerve Fibers - pathology
Optic Disk - pathology
Papilledema - diagnosis
Papilledema - pathology
Prospective Studies
Quality Control
Reproducibility of Results
Retinal Ganglion Cells - pathology
Tomography, Optical Coherence - standards
Young Adult
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Summary:Optical coherence tomography (OCT) has been used to investigate papilledema in single-site, mostly retrospective studies. We investigated whether spectral-domain OCT (SD-OCT), which provides thickness and volume measurements of the optic nerve head and retina, could reliably demonstrate structural changes due to papilledema in a prospective multisite clinical trial setting. At entry, 126 subjects in the Idiopathic Intracranial Hypertension Treatment Trial (IIHTT) with mild visual field loss had optic disc and macular scans, using the Cirrus SD-OCT. Images were analyzed by using the proprietary commercial and custom 3D-segmentation algorithms to calculate retinal nerve fiber layer (RNFL), total retinal thickness (TRT), optic nerve head volume (ONHV), and retinal ganglion cell layer (GCL) thickness. We evaluated variability, with interocular comparison and correlation between results for both methods. The average RNFL thickness > 95% of normal controls in 90% of eyes and the RNFL, TRT, ONH height, and ONHV showed strong (r > 0.8) correlations for interocular comparisons. Variability for repeated testing of OCT parameters was low for both methods and intraclass correlations > 0.9 except for the proprietary GCL thickness. The proprietary algorithm-derived RNFL, TRT, and GCL thickness measurements had failure rates of 10%, 16%, and 20% for all eyes respectively, which were uncommon with 3D-segmentation-derived measurements. Only 7% of eyes had GCL thinning that was less than fifth percentile of normal age-matched control eyes by both methods. Spectral-domain OCT provides reliable continuous variables and quantified assessment of structural alterations due to papilledema. (ClinicalTrials.gov number, NCT01003639.).
ISSN:0146-0404
1552-5783
DOI:10.1167/iovs.14-14960