Clinical validation of a smartphone-based handheld fundus camera for the evaluation of optic nerve head

ABSTRACT Purpose: To compare the quality of retinal images captured with a smartphone-based, handheld fundus camera with that of retinal images captured with a commercial fundus camera and to analyze their agreement in determining the cup-to-disc ratio for a cohort of ophthalmological patients. Methods: A total of 50 patients from a secondary ophthalmic outpatient service center underwent a bilateral fundus examination under mydriasis with a smartphone-based, handheld fundus camera and with a commercial fundus camera (4 images/patient by each). Two experienced ophthalmologists evaluated all the fundus images and graded them on the Likert 1-5 scale for quality. Multivariate regression analyses was then performed to evaluate the factors associated with the image quality. Two masked ophthalmologists determined the vertical cup-to-disc ratio of each fundus image, and both the intraobserver (between devices) and interobserver agreement between them was calculated. Results: Ninety-eight images from 49 patients were processed in this study for their quality analysis. Ten images from five patients (four from commercial fundus camera and one from smartphone-based, handheld fundus camera) were not included in the analyses due to their extremely poor quality. The medians [interquartile interval] of the image quality were not significantly different between those from the smartphone-based, handheld fundus camera and from the commercial fundus camera (4 [4-5] versus 4 [3-4] respectively, p=0.06); however, both the images captured with the commercial fundus camera and the presence of media opacity presented a significant negative correlation with the image quality. Both the intraobserver [intraclass correlation coefficient (ICC)=0.82, p