Performance Validation of a New Portable Ophthalmic Ultrasound Device

Purpose This study aimed to compare a new indigenous portable ophthalmic ultrasound device with an industry-standard multinational device for its accuracy, precision, and potential use in home care. Methods Axial and transverse images were compared for the same eye at the same visit using the India-made and multinational-made industry-standard devices for several common and rare vitreoretinal conditions in a large referral center in India. All images were obtained by the same optometrist on the same day using the India- and multinational-made devices in that sequence. Two third-year retina fellow investigators masked to the diagnosis and device analyzed the images for inter- and intra-observer accuracy of clinical diagnosis. The clinical diagnosis was compared with a senior vitreoretinal faculty member. Results The study included 118 eyes scanned once with each device. The overall accuracy was 88.9% for the portable India-made device and 85.5% for the multinational-made device. The inter-observer agreement and kappa were the same for the India-made and multinational-made devices; these were 91.52% and 0.83, respectively. The intra-observer agreement for various diagnoses for grader 1 was 95% (Cohen's kappa: 0.89) and for grader 2 was 93.3% (Cohen's kappa: 0.86). Conclusion The India-made portable ophthalmic ultrasound device was non-inferior to the multinational-made device in clinical utility. Its advantages were portability, lesser cost, and ease of use, which make the device more suitable for home eye care.