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    Guidance assessment consultation document for HTG10868 Digital technologies to support home monitoring of vision changes for people with advanced dry age-related macular degeneration: early-use assessment

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    2 Information about the technologies

    2.1

    Four digital technologies for monitoring vision changes were included in this evaluation: Alleye (Oculocare Medical Inc), Digivis DVA (Cambridge Medical Innovation Ltd), OdySight (Tilak Healthcare) and OKKO for AMD (OKKO Health). These are proposed to be used as an adjunct to standard care. An overview of the 4 technologies included in the guidance is shown in table 1. Further detail on the technologies is in table 3 of the external assessment group (EAG) report.

    The technologies measure hyperacuity, visual acuity, distortion, or a combination of these to detect changes that could indicate development of wet AMD (also known as neovascular AMD). The technologies are used on an app or web page. They have functionality to share the results with clinicians and patients.

    The committee agreed that Peek Acuity Pro, which was initially included, is out of scope for this evaluation because it is not intended for monitoring vision changes at home in people with advanced dry AMD (also known as geographic atrophy). The technology's intended use is for screening for vision problems in the community in developing countries.

    Table 1: overview of technology features

    Technology name
    (Company)

    Intended use

    Regulation

    Platform

    Functionality

    Alleye
    (Oculocare Medical Inc)

    Macular diseases including dry AMD, wet AMD, diabetic macular oedema and retinal vein occlusion

    Class 1 CE mark

    Smartphone app

    • Hyperacuity test

    • Results submitted to clinician dashboard with alerts monitored by secondary care team, with alarm to prompt review

    Digivis DVA
    (Cambridge Medical Innovation Ltd)

    To allow users of ophthalmology services to perform a test of distance visual acuity without assistance from a healthcare professional

    Class 1 CE mark

    Web-based test, requiring 2 internet connected devices

    • Distance visual acuity replicating Early Treatment Diabetic Retinopathy Study chart testing

    • Results reported to users and clinicians

    OdySight
    (Tilak Healthcare)

    Adults with chronic macular diseases complicated by choroidal neovascularisation or macular oedema requiring treatment / at risk of developing choroidal neovascularisation or macular oedema

    Class 1 CE mark

    Smartphone app

    • Visual acuity and Amsler grid

    • Results reported to users and clinicians

    OKKO for AMD
    (OKKO Health)

    People with age-related macular degeneration

    Class 1 CE mark

    Smartphone app

    • Puzzle games to detect changes in visual acuity or distortion

    • Results reported to users and clinicians

    Sustainability

    2.2

    For information, Carbon Reduction Plans for UK carbon emissions, or a commitment to reducing greenhouse gas emissions and achieving net zero, are published here for each company:

    • Oculocare has stated a commitment to transition to net zero greenhouse gas emissions by 2050 and the ongoing development of a carbon reduction framework: Oculocare net zero commitment

    • Cambridge Medical Innovation Ltd, Tilak Healthcare and OKKO Health did not provide Carbon Reduction Plans for UK carbon emissions or a net zero commitment.