TY - JOUR
T1 - Implementation and Evaluation of a Mobile Retinal Image Acquisition System for Screening Diabetic Retinopathy
T2 - Study Protocol
AU - Rêgo, Sílvia
AU - Monteiro-Soares, Matilde
AU - Dutra-Medeiros, Marco
AU - Soares, Filipe
AU - Dias, Cláudia Camila
AU - Nunes, Francisco
N1 - Funding Information:
This work was supported by EyeFundusScopeNEO: Demonstration of EyeFundusScope with Non-Expert Ophthalmology Users, cofounded by Portugal 2020, framed under the Operational Program Competitiveness and Internationalization (COMPETE 2020) and European Regional Development Fund from European Union, with operation code POCI-01-0247-FEDER-038400.
Publisher Copyright:
© 2022 by the authors.
PY - 2022/3
Y1 - 2022/3
N2 - Screening diabetic retinopathy, a major cause of blindness, is time-consuming for ophthalmologists and has some constrains in achieving full coverage and attendance. The handheld fundus camera EyeFundusScope was recently developed to expand the scale of screening, drawing on images acquired in primary care and telescreening made by ophthalmologists or a computer-aided diagnosis (CADx) system. This study aims to assess the diagnostic accuracy of the interpretation of images captured using EyeFundusScope and perform its technical evaluation, including image quality, functionality, usability, and acceptance in a real-world clinical setting. Physicians and nurses without training in ophthalmology will use EyeFundusScope to take pictures of the retinas of patients with diabetes and the images will be classified for the presence or absence of diabetic retinopathy and image quality by a panel of ophthalmologists. A subgroup of patients will also be examined with the reference standard tabletop fundus camera. Screening results provided by the CADx system on images taken with EyeFundusScope will be compared against the ophthalmologists’ analysis of images taken with the tabletop fundus camera. Diagnostic accuracy measures with 95% confidence intervals (CIs) will be calculated for positive and negative test results. Proportion of each category of image quality will be presented. Usability and acceptance results will be presented qualitatively.
AB - Screening diabetic retinopathy, a major cause of blindness, is time-consuming for ophthalmologists and has some constrains in achieving full coverage and attendance. The handheld fundus camera EyeFundusScope was recently developed to expand the scale of screening, drawing on images acquired in primary care and telescreening made by ophthalmologists or a computer-aided diagnosis (CADx) system. This study aims to assess the diagnostic accuracy of the interpretation of images captured using EyeFundusScope and perform its technical evaluation, including image quality, functionality, usability, and acceptance in a real-world clinical setting. Physicians and nurses without training in ophthalmology will use EyeFundusScope to take pictures of the retinas of patients with diabetes and the images will be classified for the presence or absence of diabetic retinopathy and image quality by a panel of ophthalmologists. A subgroup of patients will also be examined with the reference standard tabletop fundus camera. Screening results provided by the CADx system on images taken with EyeFundusScope will be compared against the ophthalmologists’ analysis of images taken with the tabletop fundus camera. Diagnostic accuracy measures with 95% confidence intervals (CIs) will be calculated for positive and negative test results. Proportion of each category of image quality will be presented. Usability and acceptance results will be presented qualitatively.
KW - diabetic retinopathy
KW - diagnostic accuracy
KW - image quality
KW - interoperator agreement
KW - usability
UR - http://www.scopus.com/inward/record.url?scp=85128898559&partnerID=8YFLogxK
U2 - 10.3390/diabetology3010001
DO - 10.3390/diabetology3010001
M3 - Article
AN - SCOPUS:85128898559
VL - 3
SP - 1
EP - 16
JO - Diabetology
JF - Diabetology
IS - 1
ER -
