Abstract
Purpose :
Compare a new portable ophthalmic ultrasound device made in India with an industry-standard device for its accuracy and precision, and potential use in home care.
Methods :
Axial and transverse images were obtained for the same eye at the same visit using the new India-make and industry-standard devices for several common and rare conditions seen in the vitreoretinal clinic of a large referral center in India. All images were obtained by the same optometrist on the same day using the new India -make device first followed by the multinational- make device. Two masked final year retina fellow investigators analyzed the images after all clinical information were removed from the images, for inter- and intra-observer agreement of clinical diagnosis. Inter-observer agreement was measured for all images and intra-observer agreement was measured for 60 images shared a fortnight after the first assessment. The clinical diagnosis was compared with one vitreoretinal faculty.
Results :
The portable India make B-scan device consists of the console, 10 MHz ultrasound probe, a foot pedal, and specifically configured 13.5 inches laptop housed in suitcase that can be wheeled easily. The console is electrically charged (250 watts), the probe, the foot pedal and the laptop are attached to the console. It was 2/3rd cost of the other device. The study included 118 eyes, scanned once with each device. The overall accuracy was 88.9% for the portable India- make device and 85.5% for the multinational- make device (p= 0.31; two tailed paired sample t test). The inter-observer agreement was moderate for both devices; Cohen’s kappa 0.56 for the new India-make device Cohen’s kappa 0.63) for the multinational- make device, but statistically insignificant difference (p= 0.0832, two tailed paired sample t test). The intra-observer agreement was 95% (McNemar’s test; p=0.567). and 93.3% (McNemar’s test; p=0.428) for the grader 1 and 2, respectively
Conclusions :
The new India-make portable ophthalmic ultrasound device was non- inferior to multinational make device in clinical utility. The added advantages were its portability, ease of use, and less expensive. These factors enable the device ideal for home care, less learning curve and use in less resource communities.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.