Repeatability and Reproducibility of Corneal Epithelial Thickness Mapping With Spectral-Domain Optical Coherence Tomography in Normal and Diseased Cornea Eyes.

Abstract

To evaluate the performance of the epithelial thickness mapping (ETM) of the iVue spectral-domain optical coherence tomography (SD-OCT) device (Optovue Inc, Fremont, California, USA) in normal and diseased cornea eyes. Reliability and validity analysis. Sixty eyes of 60 subjects were recruited for the study, which included normal subjects (n = 12) and patients with corneal diseases (12 patients each: dry eye syndrome [DES], contact lens wear, post-laser refractive surgery, and keratoconus). Three repeated scans were acquired on 3 iVue SD-OCTs with device-designated operators from consented subjects. Each subject was scanned on each device. Repeatability (based on random error of repeated scans) and reproducibility (including the random error and the instrument/operator variability) were assessed based on spatial zones derived from a 6-mm-diameter corneal ETM centered on the pupil and compared between the groups. Fifty-nine eyes qualified for final analysis. Seventy-one of 598 acquired scans (11.9%) were excluded owing to scan quality concerns. The percentage of disqualified scans was similar across normal (10.7%) and diseased eyes (12.1%). Of 527 qualified scans, 40 (7.6%) scans required manual edits of the segmentation lines. Repeatability and reproducibility results were similar, indicating minimal device/operator variability for both groups. Repeatability and reproducibility were similar in all subgroups of cornea patients, excluding the DES group, for which reproducibility was significantly lower (range 3.2%-5.5% for DES patients and 1.1%-2.9% for normal subjects). The iVue SD-OCT provides good corneal ETM repeatability and reproducibility in normal and diseased cornea eyes through all map zones.