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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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    1 Recommendation

    1.1

    More research is needed on digital technologies to support home monitoring of vision changes for people with advanced dry age-related macular degeneration (AMD, also known as geographic atrophy) before they can be funded by the NHS. The technologies are:

    • Alleye

    • Digivis DVA

    • OdySight

    • OKKO for AMD.

    What this means in practice

    There is not enough evidence to support funding of digital technologies for home monitoring of vision changes for people with advanced dry AMD in the NHS.

    Access to these technologies should be through company, research or non-core NHS funding, and clinical or financial risks should be managed appropriately.

    What research is needed

    More research for digital technologies to support home monitoring of vision changes for people with advanced dry AMD is needed on:

    • diagnostic accuracy to detect progression to wet AMD (also known as neovascular AMD)

    • optimal frequency of self-monitoring

    • impact on resource use

    • time to identification of development of wet AMD

    • patient-reported usability and acceptability

    • clinician-reported acceptability

    • long-term adherence

    • changes in health-related quality of life

    • changes in functional vision including visual acuity.

    Research on the same outcomes in people with intermediate AMD would also be beneficial.

    Why the committee made this recommendation

    There is an unmet need for tools to help people with advanced dry AMD monitor their vision at home. There is currently no treatment for advanced dry AMD. If it progresses to wet AMD, that can be treated. The technologies could help address the need for monitoring tools if they can accurately detect vision changes that indicate development of wet AMD. It is important that progression to wet AMD is detected and treated quickly to help avoid permanent vision loss.

    There is limited clinical-trial evidence for using the technologies in advanced dry AMD, so their clinical effectiveness is uncertain. And the evidence may not reflect use of the technologies in the NHS because some studies were done outside the UK. Also, some of the studies are small or not restricted to people with advanced dry AMD. There is some evidence for the diagnostic performance of Alleye and OdySight. But this is limited because it does not specifically evaluate detection of wet AMD developing in people with advanced dry AMD. There is no relevant clinical-effectiveness evidence for Digivis DVA and OKKO for AMD.

    People with advanced dry AMD have reduced contrast sensitivity, so the technologies may be difficult for them to use. Also, the technologies that measure visual acuity may not detect changes in contrast sensitivity.

    Because of the limitations in the clinical evidence, the cost effectiveness of the technologies is uncertain. There is uncertainty about the assumptions used in the model because of the lack of evidence. So, more research is needed.