Baseline OCT measurements in the idiopathic intracranial hypertension treatment
trial, part I: quality control, comparisons, and variability
#MMPMID25370510
Auinger P
; Durbin M
; Feldon S
; Garvin M
; Kardon R
; Keltner J
; Kupersmith M
; Sibony P
; Plumb K
; Wang JK
; Werner JS
Invest Ophthalmol Vis Sci
2014[Nov]; 55
(12
): 8180-8
PMID25370510
show ga
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: Spectral-domain OCT provides reliable
continuous variables and quantified assessment of structural alterations due to
papilledema. (ClinicalTrials.gov number, NCT01003639.).