Home Monitoring for the Management of Age-Related Macular Degeneration: A Review of the Development and Implementation of Digital Health Solutions over a 25-Year Scientific Journey.

The management of age-related macular degeneration (AMD) presents a significant challenge attributable to high disease heterogeneity. Patient realization of symptoms is poor and it is urgent to treat before permanent anatomic damage results in vision loss. This is true for the initial conversion from non-exudative intermediate AMD (iAMD) to exudative AMD (nAMD), and for the recurrence of nAMD undergoing treatment. Starting from the essential requirements that any practical solution needs to fulfill, we will reflect on how persistent navigation towards innovative solutions during a 25-year journey yielded significant advances towards improvements in personalized care. An early insight was that the acute nature of AMD progression requires frequent monitoring and therefore diagnostic testing should be performed at the patient's home. Four key requirements were identified: (1) A tele-connected home device with acceptable diagnostic performance and a supportive patient user interface, both hardware and software. (2) Automated analytics capabilities that can process large volumes of data. (3) Efficient remote patient engagement and support through a digital healthcare provider. (4) A low-cost medical system that enables digital healthcare delivery through appropriate compensation for both the monitoring provider and the prescribing physician services. We reviewed the published literature accompanying first the development of Preferential Hyperacuity Perimetry (PHP) for monitoring iAMD, followed by Spectral Domain Optical Coherence Tomography (SD-OCT) for monitoring nAMD. Emphasis was given to the review of the validation of the core technologies, the regulatory process, and real-world studies, and how they led to the release of commercial services that are covered by Medicare in the USA. We concluded that while during the first quarter of the 21st century, the two main pillars of management of AMD were anti-VEGF intravitreal injections and in-office OCT, the addition of home-monitoring-based digital health services can become the third pillar.