Self-Examination Low-Cost Full-Field Optical Coherence Tomography (SELFF-OCT) for neovascular age-related macular degeneration: a cross-sectional diagnostic accuracy study

Abstract

ObjectivesSelf-Examination Low-Cost Full-Field Optical Coherence Tomography (SELFF-OCT) is a novel OCT technology that was specifically designed for home monitoring of neovascular age-related macular degeneration (AMD). First clinical findings have been reported before. This trial investigates an improved prototype for patients with AMD and focusses on device operability and diagnostic accuracy compared with established spectral-domain OCT (SD-OCT).DesignProspective single-arm diagnostic accuracy study.SettingTertiary care centre (University Eye Clinic).Participants46 patients with age-related macular degeneration.InterventionsPatients received short training in device handling and then performed multiple self-scans with the SELFF-OCT according to a predefined protocol. Additionally, all eyes were examined with standard SD-OCT, performed by medical personnel. All images were graded by at least 2 masked investigators in a reading centre.Primary outcome measureRate of successful self-measurements.Secondary outcome measuresSensitivity and specificity of SELFF-OCT versus SD-OCT for different biomarkers and necessity for antivascular endothelial growth factor (anti-VEGF) treatment.ResultsIn 86% of all examined eyes, OCT self-acquisition resulted in interpretable retinal OCT volume scans. In these patients, the sensitivity for detection of anti-VEGF treatment necessity was 0.94 (95% CI 0.79 to 0.99) and specificity 0.95 (95% CI 0.82 to 0.99).ConclusionsSELFF-OCT was used successfully for retinal self-examination in most patients, and it could become a valuable tool for retinal home monitoring in the future. Improvements are in progress to reduce device size and to improve handling, image quality and success rates.Trial registration numberDRKS00013755, CIV-17-12-022384.

Reducing the impact of domain shift in deep learning for OCT segmentation using image manipulations

“…A complete description of the dataset can be found in. 25 To learn further topographic information, we refined the annotations by separating the background annotation into vitreous humor and choroid (areas above and below retina). The IRF class was mapped to the retina class, because annotators expressed concern about the reliability of the IRF annotation.…”

Artificial intelligence for home monitoring devices

“…In a pilot cross-sectional study that imaged 51 participants in a laboratory setting, 94% could acquire a retinal image and 76% of scans met the quality criteria; in scans with neovascular AMD, features such as retinal fluid could be detected [44]. In a report of an improved prototype used in a clinic setting, of 46 participants with AMD, 86% of eyes had interpretable scans and the sensitivity and specificity of detecting anti-VEGF treatment necessity were high [46 ▪ ].…”

Perspectives on the Home Monitoring of Macular Disease

“…Home OCT devices necessarily provide lower quality images compared to clinic-based devices, with an example axial resolution of 12 µM compared to 3 µM for high-resolution Spectralis devices (Heidelberg) [ 15 ]. The Notal Home OCT device also scans the central 3 mm × 3 mm of the macula compared to the larger 6 mm × 6 mm commonly scanned by conventional devices [ 14 ].…”

“…The Notal Home OCT device also scans the central 3 mm × 3 mm of the macula compared to the larger 6 mm × 6 mm commonly scanned by conventional devices [ 14 ]. However, scanning times remain feasible for home imaging at 1 min or less per scan [ 14 , 15 ], and these more limited specifications may prove sufficient for use as a screening tool. Longer-term observational studies of wet AMD assessment by home OCT are needed to evaluate success of acquisition of images and determine patient satisfaction with regular home testing.…”

“…Studies of the ForeseeHome device found it to be the first factor detecting MNV in only approximately 50% of patients [ 3 , 4 ], with symptoms and clinic scans accounting for the remainder. While early studies suggest home OCT will be significantly more sensitive [ 15 ], when translated to the population level even modest false negative rates are likely to represent a large number of delayed diagnoses if home monitoring is relied upon alone. Indeed, a previous study found agreement between analysis software and expert graders in only 83% of scans [ 13 ].…”