The Impact of Artificial Intelligence on Retinal Disease Management

Vision Academy Retinal Expert Consensus

Carla Danese; Aditya U. Kale; Tariq Aslam; Paolo Lanzetta; Jane Barratt; Yu-Bai Chou; Bora Eldem; Nicole Eter; Richard Gale; Jean-François Korobelnik; Igor Kozak; Xiaorong Li; Xiaoxin Li; Anat Loewenstein; Paisan Ruamviboonsuk; Taiji Sakamoto; Daniel S.W. Ting; Peter van Wijngaarden; Sebastian M. Waldstein; David Wong; Lihteh Wu; Miguel A. Zapata; Javier Zarranz-Ventura

Disclosures

Curr Opin Ophthalmol. 2023;34(5):396-402.

Abstract and Introduction

Abstract

Purpose of Review: The aim of this review is to define the "state-of-the-art" in artificial intelligence (AI)-enabled devices that support the management of retinal conditions and to provide Vision Academy recommendations on the topic.

Recent Findings: Most of the AI models described in the literature have not been approved for disease management purposes by regulatory authorities. These new technologies are promising as they may be able to provide personalized treatments as well as a personalized risk score for various retinal diseases. However, several issues still need to be addressed, such as the lack of a common regulatory pathway and a lack of clarity regarding the applicability of AI-enabled medical devices in different populations.

Summary: It is likely that current clinical practice will need to change following the application of AI-enabled medical devices. These devices are likely to have an impact on the management of retinal disease. However, a consensus needs to be reached to ensure they are safe and effective for the overall population.

Introduction

Artificial intelligence (AI) is a branch of computer science, statistics, and engineering that uses algorithms or models to perform tasks that mimic human capabilities.^[1] Machine learning is a subset of AI that allows computer algorithms to learn through data to perform a task without being explicitly programmed.^[1] The value of digital technologies in contributing to advancing universal health coverage has been recognized. A consensus was reached on the need for more research on the acceptability, feasibility, and ethics regarding the use of AI for the development of decision support systems.^[2]

There is great interest in developing AI medical devices, especially in imaging-focused specialties such as ophthalmology.^[3] At present, there is no consensus on the evidence requirements for AI medical devices in ophthalmology.^[3]

Most of the AI medical devices licensed for clinical application in ophthalmology by regulatory authorities such as the U.S. Food and Drug Administration and Conformité Européenne are approved for diagnostic purposes rather than for disease management. Chou and colleagues, on behalf of the Vision Academy, have developed an accompanying expert consensus paper on the use of AI medical devices in diagnosis and screening.^[4] This paper will focus on the capabilities of AI in predicting functional and structural changes during retinal disease, as well as treatment outcomes of patients affected by retinal diseases.

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Next Section

Abstract and Introduction
Overview of Approved Artificial Intelligence Medical Devices for Retinal Disease Management
Vision Academy Recommendations
Conclusion
References
Sidebar

Table 1. Summary of current AI systems with regulatory approval for retinal disease management
AI system	Company	Year approved	Regulatory authority	Exam analyzed	Target	Impact on prognosis	Cloud-based?
Retmarker DR Biomarker [5]	Retmarker, SA, Taveiro, Portugal	2010	CE, TGA (Australia)	Color fundus images	DR	Identification of the risk of complications	No
Notal Home OCT [6]	Notal Vision, Inc., Manassas, VA, USA	2018	FDA (Breakthrough Device Designation)	OCT	Neovascular AMD	Early detection of fluid	Yes
Notal OCT Analyzer [7]	Notal Vision, Inc., Manassas, VA, USA	2018	FDA (Breakthrough Device Designation)	OCT	Neovascular AMD, DME, RVO	Automated detection of fluid	Yes
RetinAI Discovery [8]	RetinAI Medical AG, Bern, Switzerland	2020	CE, FDA	OCT, color fundus images	AMD, DR, epiretinal membranes, other	Strict follow-up	Yes
VUNO Med-Fundus AI [9]	VUNO Inc., Seoul, Korea	2020	CE, MFDS (Korea), HAS (Singapore)	Color fundus images	AMD, DR, epiretinal membranes, other	Strict follow-up	No
iPredict [10]	iHealthScreen Inc., Richmond Hill, NY, USA	2021 and 2022	CE, TGA (Australia)	OCT, color fundus images	AMD, DR	Prediction of progression	Yes
RetInSight Fluid Monitor [11]	RetInSight GmbH, Vienna, Austria	2022	CE	OCT	AMD, DME	Automated detection of fluid	Yes

Note: All AI algorithms involved in the management of retinal diseases which had already received approval from the FDA, CE, or other regulatory authorities, or were undergoing the process of approval were included. These devices were searched for in the European Database on Medical Devices (EUDAMED) database , the FDA website (on the webpage of Artificial Intelligence and Machine Learning-Enabled Medical Devices) , and the FDA 510(k) Premarket Notification . Algorithms that had received approval between January 2015 and December 2022 were included. We searched PubMed for available literature on the scientific evidence of the efficacy of these systems and for additional details regarding newer, unapproved algorithms. Only English-written articles published up to March 2023 were considered.
AMD, age-related macular degeneration; CE, Conformité Européenne; DME, diabetic macular edema; DR, diabetic retinopathy; FDA, U.S. Food and Drug Administration; MFDS, Ministry of Food and Drug Safety (Korea); OCT, optical coherence tomography; RVO, retinal vein occlusion; TGA, Therapeutic Goods Administration.

Authors and Disclosures

Carla Danese^a,b,*, Aditya U. Kale^c,*, Tariq Aslam^d,*, Paolo Lanzetta^a,n,*, Jane Barratt^e, Yu-Bai Chou^f,g, Bora Eldem^h, Nicole Eterⁱ, Richard Gale^j, Jean-François Korobelnik^k,l, Igor Kozak^m, Xiaorong Li^o, Xiaoxin Li^p, Anat Loewenstein^q, Paisan Ruamviboonsuk^r, Taiji Sakamoto^s, Daniel S.W. Ting^t, Peter van Wijngaarden^u,v, Sebastian M. Waldstein^w, David Wong^x, Lihteh Wu^y, Miguel A. Zapata^z and Javier Zarranz-Ventura^aa

^aDepartment of Medicine – Ophthalmology, University of Udine, Udine, Italy, ^bDepartment of Ophthalmology, AP-HP Hôpital Lariboisière, Université Paris Cité, Paris, France, ^cAcademic Unit of Ophthalmology, Institute of Inflammation & Ageing, College of Medical and Dental Sciences, University of Birmingham, Birmingham, ^dDivision of Pharmacy and Optometry, Faculty of Biology, Medicine and Health, University of Manchester School of Health Sciences, Manchester, UK, ^eInternational Federation on Ageing, Toronto, Canada, ^fDepartment of Ophthalmology, Taipei Veterans General Hospital, ^gSchool of Medicine, National Yang Ming Chiao Tung University, Taipei, Taiwan, ^hDepartment of Ophthalmology, Hacettepe University, Ankara, Turkey, ⁱDepartment of Ophthalmology, University of Münster Medical Center, Münster, Germany, ^jDepartment of Ophthalmology, York Teaching Hospital NHS Foundation Trust, York, UK, ^kService d'ophtalmologie, CHU Bordeaux, ^lUniversity of Bordeaux, INSERM, BPH, UMR1219, F-33000 Bordeaux, France, ^mMoorfields Eye Hospital Centre, Abu Dhabi, UAE, ⁿIstituto Europeo di Microchirurgia Oculare, Udine, Italy, ^oTianjin Key Laboratory of Retinal Functions and Diseases, Tianjin Branch of National Clinical Research Center for Ocular Disease, Eye Institute and School of Optometry, Tianjin Medical University Eye Hospital, Tianjin, ^pXiamen Eye Center, Xiamen University, Xiamen, China, ^qDivision of Ophthalmology, Tel Aviv Sourasky Medical Center, Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel, ^rDepartment of Ophthalmology, College of Medicine, Rangsit University, Rajavithi Hospital, Bangkok, Thailand, ^sDepartment of Ophthalmology, Kagoshima University, Kagoshima, Japan, ^tSingapore National Eye Center, Duke-NUS Medical School, Singapore, ^uOphthalmology, Department of Surgery, University of Melbourne, Melbourne, Australia, ^vCentre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, East Melbourne, Victoria, Australia, ^wDepartment of Ophthalmology, Landesklinikum Mistelbach-Gänserndorf, Mistelbach, Austria, ^xUnity Health Toronto – St. Michael's Hospital, University of Toronto, Toronto, Canada, ^yMacula, Vitreous and Retina Associates of Costa Rica, San José, Costa Rica, ^zOphthalmology Department, Hospital Vall d'Hebron and ^aaHospital Clínic de Barcelona, University of Barcelona, Barcelona, Spain

Correspondence to
Tariq Aslam, Division of Pharmacy and Optometry, Faculty of Biology, Medicine and Health, University of Manchester School of Health Sciences, Manchester M13 9PL, UK. Tel: +44 161 2761234; e-mail: tariq.aslam@mft.nhs.uk

*Lead author, on behalf of the Vision Academy Retinal AI Workstream.

Conflicts of interest
Carla Danese is a consultant for Bayer. Tariq Aslam is a consultant for, and has received grants, speaker fees, and honoraria from, Allergan, Bayer Pharmaceuticals, Canon, NIHR, Roche, and Topcon. He is also a board member for the Vision Academy, Macular Society, and Fight for Sight charity. Jane Barratt has received honoraria from Bayer. Yu-Bai Chou is a consultant for Alcon and Bayer. Bora Eldem is a consultant for Allergan, Bayer, Novartis, and Roche. Nicole Eter is an advisor for AbbVie, Alcon, Apellis, Bayer, Biogen, Janssen, Novartis, and Roche and has received speaker fees from AbbVie, Apellis, Bayer, Novartis, and Roche and research grants from Bayer and Novartis. Richard Gale is a consultant for AbbVie, Allergan, Apellis, Bayer, Biogen, Boehringer Ingelheim, Notal, Novartis, Roche, and Santen and has received research grants from Bayer, Novartis, and Roche. Jean-François Korobelnik is a consultant for Allergan/AbbVie, Apellis, Bayer, Carl Zeiss Meditec, Janssen, Nano Retina, Roche, and Théa and is a member of the Data and Safety Monitoring Boards for Alexion and Novo Nordisk. Igor Kozak is a consultant for Alcon, Bayer, and Novartis. Paolo Lanzetta is a consultant for Aerie, AbbVie, Apellis, Bausch & Lomb, Bayer, Biogen, Boehringer Ingelheim, Genentech, Novartis, Ocular Therapeutix, Outlook Therapeutics, and Roche. Anat Loewenstein is a consultant for Allergan, Annexon, Bayer Healthcare, Beyeonics, Biogen, ForSight Labs, IQVIA, Iveric Bio, Johnson & Johnson, MJH Events, Nano Retina, Notal Vision, Novartis, Ocuphire Pharma, OcuTerra, OphtiMedRx, Roche, Ripple Therapeutics, Syneos, WebMD, and Xbrane. Paisan Ruamviboonsuk is a consultant for, and has received research funds from, Bayer and Roche. Taiji Sakamoto is a consultant for Bayer Yakuhin, Boehringer Ingelheim, Chugai, Nidek, Nikon, Novartis, Santen, and Senju. Daniel S.W. Ting has received research grants from the National Medical Research Council Singapore, Duke-NUS Medical School Singapore, and Agency for Science, Technology and Research Singapore. Peter van Wijngaarden is the co-founder of Enlighten Imaging, an early-stage medical technology start-up company devoted to hyperspectral retinal imaging and image analysis, including the development of AI systems, and has received research grant support from Bayer and Roche and honoraria from Bayer, Mylan, Novartis, and Roche. Sebastian M. Waldstein is a consultant for Apellis, Bayer, Boehringer Ingelheim, Novartis, Roche, and Santen. David Wong is a consultant for AbbVie, Alcon, Apellis, Bayer, Bausch Health, Biogen, Boehringer Ingelheim, Novartis, Ripple Therapeutics, Roche, Topcon, and Zeiss, has received financial support (to institution) from Bayer, Novartis, and Roche, and is an equity owner at ArcticDx. Lihteh Wu is a consultant for Bayer, Lumibird Medical, Novartis, and Roche. Miguel A. Zapata is a consultant for Novartis and Roche, has received grants and speaker fees from DORC, Novartis, and Roche, honoraria from Alcon, Bayer, DORC, Novartis, and Roche, has served on advisory boards for Novartis and Roche, has received equipment from Allergan, and has stock or stock options in UpRetina. Javier Zarranz-Ventura has received grants from AbbVie, Allergan, Bayer, Novartis, and Roche, has served on scientific advisory boards for AbbVie, Allergan, Bayer, Novartis, and Roche, and has been a speaker for AbbVie, Alcon, Alimera Sciences, Allergan, Bausch & Lomb, Bayer, Brill Pharma, DORC, Esteve, Novartis, Roche, Topcon Healthcare, and Zeiss. Aditya U. Kale, Xiaorong Li, and Xiaoxin Li have no conflicts of interest to report.