Assessment of an Augmented Reality Low Visual Aid in Children and Young People With Visual Impairment
Condition: Vision Disability
MeSH terms: Vision Disorders; Vision, Low
Study type: Interventional

Summary: 
      Approximately 24,500 children and young people (CYP) in England have a visual impairment
      (VI). VI refers to a loss of vision that cannot be corrected with glasses or contact lenses.

      Low vision aids (e.g. magnifying glasses) can help CYP with a VI see more clearly. However,
      current low vision aids are not suitable for many of the activities CYP regularly engage in,
      such as watching TV or school lessons.

      SightPlus is an advanced head-mounted digital low vision aid for CYP and adults. SightPlus
      helps people with a VI use their remaining vision to see more clearly up close and at a
      distance.

      SightPlus was recently tested at Moorfields Eye Hospital in London with 60 adults with a VI.
      The results showed that adults could see more clearly while using SightPlus.

      The study proposed here aims to find out whether SightPlus can improve the vision and quality
      of life of CYP aged 8-16 years with a VI.

      For this study, 25 CYP will come to Sheffield Children's Hospital (SCH) for an 80-minute
      session with parents/guardians where they will have their vision tested, complete
      questionnaires measuring their vision-related quality of life and functional vision (i.e.
      what someone can see), and learn how to use SightPlus.

      CYP will then be asked to use SightPlus for four weeks. Parents/guardians will record the
      activities CYP use SightPlus for in a home diary.

      After four weeks, CYP and their parents/guardians will come back to SCH for a 90-minute
      session where they will have their vision tested with and without SightPlus, complete another
      vision-related quality of life and functional vision questionnaire, hand in their home diary,
      and complete a feedback form about their experiences of using SightPlus.

      This study will help us find out whether SightPlus can improve the vision and quality of life
      of CYP with a VI.
    

Detailed description: 
      This study aims to assess the impact of a head-mounted augmented reality low vision aid
      (SightPlus) on vision and quality of life in CYP aged 8-16 years with moderate or severe VI.

      There are 24,500 children and young people (CYP) with a moderate or severe visual impairment
      (VI) in England, of which 9,535 are registered as blind or partially sighted. CYP with VI
      have to live with sight loss that significantly impacts their daily lives. VI often has
      adverse effects on CYP's social, educational, psychological, and physical development and
      quality of life.

      CYP with a moderate or severe VI have some vision but the image can be very blurry. Low
      vision aids (e.g. optical magnifiers) can improve CYP's functional vision (i.e. what an
      individual can actually see). Low vision aids therefore have the potential to significantly
      improve independent living, access to education/work, and quality of life.

      However, current low vision aids are very limited in their functionality. For instance,
      optical magnifiers require the user to place the device over a section of text and bend over
      to read the magnified text. Current low vision aids are therefore largely unsuitable for the
      types of activities CYP typically engage in, such as school lessons, playing a musical
      instrument, and socialising with friends and family. There is a clear need for innovative low
      vision aids for CYP with VI.

      SightPlus is a hands-free, head-mounted, digital low vision aid for CYP and adults with VI.
      SightPlus combines augmented and virtual reality by using the backlit screen of a mobile
      phone, placed inside a virtual reality headset, to display augmented imagery of what the user
      is looking at. SightPlus has various modes depending on the user's needs and enables users to
      see clearly both up close and at a distance. Thus, SightPlus enables individuals to use their
      residual sight to regain functional vision, empowering users to engage in a wide range of
      daily activities.

      In 2017, GiveVision conducted a pilot study to assess the functionality, usability, and
      acceptability of SightPlus. 194 individuals (including 23 CYP aged 8-16 years) participated
      in a 1:1 training session. Following this session, participants were given the opportunity to
      trial the device at home for 2 weeks. 87% of CYP (20/23) participated in the two-week trial.
      During the trial, 75% of CYP used SightPlus for schoolwork and reported that school was a
      deciding factor in wanting to keep the device. 70% of CYP also used SightPlus for hobbies,
      including watching TV, playing games, reading, and playing a musical instrument. Critically,
      6-9 months later, 71% of CYP still used SightPlus daily and 80% reported having greater
      independence and being able to do activities they were previously unable to do (e.g. reading
      normal print books).

      GiveVision subsequently conducted a clinical study in collaboration with Moorfields Eye
      Hospital NHS Foundation Trust. This study examined the impact of SightPlus on visual acuity
      (i.e. clarity of vision) and contrast sensitivity (i.e. ability to distinguish an object from
      its background) in 60 adults with moderate or severe VI. After a one-hour training session,
      SightPlus was found to significantly improve visual acuity and contrast sensitivity, and
      participants reported that they would like to use the device for watching TV, reading,
      education, and going to the theatre/cinema.

      The study proposed here aims to build on and extend the work conducted so far to assess
      whether a head-mounted augmented reality low vision aid can clinically improve vision and
      vision-related quality of life in CYP with moderate or severe VI.
    

Intervention name(s): SightPlus
Intervention type(s): Device
Intervention description(s): SightPlus is a head-mounted, augmented reality low vision aid. SightPlus enables people with a visual impairment to use their remaining vision to see more clearly up close and at a distance. SightPlus is commercially available, non-invasive, CE marked, and a MHRA approved class 1 medical device.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment