This was an observational study conducted at the Department of Ophthalmology and Visual Sciences, The University of Texas Medical Branch (UTMB) at Galveston, Texas, United States. The study was approved by the UTMB Institutional Review Board, and all methods adhered to the tenets of the Declaration of Helsinki and the Health Insurance Portability and Accountability Act. Written informed consent to participate was obtained from all subjects after explanation of the nature and possible consequences of the study.
As part of the GLAucoma Diagnostic Imaging UTMB Study (GLADIUS), a prospective study designed to investigate modern glaucoma imaging devices, participants underwent a complete ophthalmologic examination, including review of medical history, best corrected visual acuity, slit lamp examination, gonioscopy, Goldmann applanation tonometry, dilated funduscopic examination with a 78–diopter (D) lens, spectral-domain optical coherence tomography (SD-OCT) scanning sessions, standard automated perimetry using Humphrey Field Analyzer II (Carl Zeiss Meditec), and stereoscopic optic disc photography using Topcon TRC-NW6S (Topcon Corporation, Tokyo, Japan). To be included in this study, participants had to have spherical refraction between ±5 D, cylinder between ±3 D, and open angle at gonioscopy. Subjects were excluded if they had coexisting retinal diseases, uveitis, nonglaucomatous optic neuropathy, history of intraocular surgery other than uncomplicated cataract or glaucoma surgery, or significant media opacities.
Eyes were classified as healthy or glaucomatous by two independent glaucoma specialists (MFS and GV) according to the absence or presence of structural glaucomatous damage to the optic disc or the RNFL. Typical glaucomatous damage included focal or diffuse neuroretinal rim thinning, cupping, optic disc hemorrhages, peripapillary atrophy, or wedge-shaped RNFL defects. The assessment was performed on color optic disc digital stereophotographs by using a hand-held stereoscopic viewer (Screen-Vu Stereo Viewer, Portland, OR). The two graders were masked to the participants' demographic and ophthalmic information, and to the other evaluator's results. In case of disagreement adjudication was achieved by consensus.
If eligible, both eyes of the same individual were included in this study.