Vision DisabilityNCT05201482
Assessment of an Augmented Reality Low Visual Aid in Children and Young People With Visual Impairment
A study testing SightPlus in people with Vision Disability, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 16 years
- Conditions the study is for
- Vision Disability
- What is being tested?
- SightPlus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Oct 2021to 3 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged 8-16 years
- Corrected visual acuity equal to lower than 6/18 and equal to or better than 3/60 with both eyes open
- Central vision loss or vision loss affecting the whole visual field
- Currently cared for by the Eye Department at Sheffield Children's Hospital
- Patient and parents/guardians fluent in verbal and written English
- No physical or cognitive difficulties which indicate the child or young person would struggle to use device or complete the study activities
Who cannot join
- Aged <8 years or >17 years
- Corrected visual acuity not lower than 6/18 or equal to or better than 3/60 with both eyes open
- History of neurological conditions, such as epilepsy or seizures
- Children with a pacemaker or other implanted medical device
- Not currently cared for by the Eye Department at Sheffield Children's Hospital
- Patients or parents/guardian non-fluent in verbal and written English
- Physical or cognitive difficulties which indicate the child or young person would struggle to use device or complete the study activities
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Clinical Research Facility
Sheffield, Sheffield (South Yorkshire District), S10 2TH
About this study
Official title: Assessing the Impact of a Head-mounted Augmented Reality Low Vision Aid on Vision and Quality of Life in Children and Young People With Visual Impairment
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.
Read more
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.
Read the 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.
- Conditions
- Vision Disability
- Being tested
- SightPlus
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SightPlusDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 25 patients aged 8-16 years with moderate or severe visual impairment | Experimental | 25 patients aged 8-16 years with moderate or severe visual impairment will test the impact of a head-mounted augmented reality low vision aid (SightPlus) on vision and quality of life Receives: Device: SightPlus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess change in maximum reading speed in patients aged 8-16 years with moderate or severe visual impairment
Maximum reading speed will be assessed using MNRead
Measured: Perform test at first study visit (50 min duration), then let the patient use the SightPlus device for four weeks and then perform test again at the second study visit (70 min duration)
Assess change in reading acuity in patients aged 8-16 years with moderate or severe visual impairment
Reading acuity will be assessed using MNRead
Measured: Perform test at first study visit (50 min duration), then let the patient use the SightPlus device for four weeks and then perform test again at the second study visit (70 min duration)
Assess change in binocular visual acuity in patients aged 8-16 years with moderate or severe visual impairment
Binocular visual acuity will be measured using Keeler Crowded logMAR
Measured: Perform test at first study visit (50 min duration), then let the patient use the SightPlus device for four weeks and then perform test again at the second study visit (70 min duration)
Assess change in near visual acuity in patients aged 8-16 years with moderate or severe visual impairment
Near visual acuity will be measured using Sloan reduced logMAR
Measured: Perform test at first study visit (50 min duration), then let the patient use the SightPlus device for four weeks and then perform test again at the second study visit (70 min duration)
Assess change in contrast sensitivity in patients aged 8-16 years with moderate or severe visual impairment
Contrast Sensitivity will be measured using the Evans Low Contrast Sensitivity test
Measured: Perform test at first study visit (50 min duration), then let the patient use the SightPlus device for four weeks and then perform test again at the second study visit (70 min duration)
Assess change in facial expressions in patients aged 8-16 years with moderate or severe visual impairment
Facial expressions will be assessed using the NimStim Dataset and the number of errors will be counted
Measured: Perform test at first study visit (50 min duration), then let the patient use the SightPlus device for four weeks and then perform test again at the second study visit (70 min duration)
Assess change in vision-related quality of life in patients aged 8-16 years with moderate or severe visual impairment
Patients will asked to complete baseline and post-trial vision-related quality of life questionnaires.
Measured: Ask patients to complete the baseline questionnaire immediately after the first visit at home and to complete the post-trial questionnaire at home at end of the four week trial period (with the Sightplus device) and return this at the 2nd clinic visit
Assess change in functional vision in patients aged 8-16 years with moderate or severe visual impairment
Patients will asked to complete baseline and post-trial functional vision questionnaires.
Measured: Ask patients to complete the baseline questionnaire immediately after the first visit at home and to complete the post-trial questionnaire at home at end of the four week Sightplus device trial period and return this at the 2nd clinic visit
Determine how and when patients aged 8-16 years with moderate or severe visual impairment use the SightPlus device
Patients will be given a home diary to complete during the four week trial using the SightPlus device.
Measured: The home diary is completed by the patient at home during the four week trial of the SightPlus device when it is used. The home diary is returned during the second visit to the clinic
Determine usability and acceptability of Sightplus device
Patients and parents/carers will be given a usability/acceptability feedback form to complete
Measured: Patients and parents/carers will be given usability/acceptability feedback form to complete at home at the end of the four-week trial period. They will return this at the second clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start5 Oct 2021
- Primary completion3 May 2022
- Study completion3 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vision DisabilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Children's NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Finnguala Burgum, Principal investigator, Sheffield Children's NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05201482
- Sponsor's protocol ID
- SCH-2551
- Status last verified
- Sep 2022
- First submitted
- 4 Jun 2021
- Last updated
- 8 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of a Head-mounted Augmented Reality Low Vision Aid on Vision and Quality of Life in Children and Young People With Visual Impairment
- ClinicalTrials.gov ID
- NCT05201482
- Acronym / sponsor ID
- SCH-2551
- Conditions
- Vision Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Sheffield Children's NHS Foundation TrustUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 3 May 2022 (actual)
- First posted
- 21 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 25 patients aged 8-16 years with moderate or severe visual impairment | Experimental | Device: SightPlus25 patients aged 8-16 years with moderate or severe visual impairment will test the impact of a head-mounted augmented reality low vision aid (SightPlus) on vision and quality of life |
Who may qualify
- Ages
- 8 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Aged 8-16 years
- Corrected visual acuity equal to lower than 6/18 and equal to or better than 3/60 with both eyes open
- Central vision loss or vision loss affecting the whole visual field
- Currently cared for by the Eye Department at Sheffield Children's Hospital
- Patient and parents/guardians fluent in verbal and written English
Key exclusion criteria (7 listed)
- Aged <8 years or >17 years
- Corrected visual acuity not lower than 6/18 or equal to or better than 3/60 with both eyes open
- History of neurological conditions, such as epilepsy or seizures
- Children with a pacemaker or other implanted medical device
- Not currently cared for by the Eye Department at Sheffield Children's Hospital
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SightPlusSightPlus 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. | Device | 25 patients aged 8-16 years with moderate or severe visual impairment |
Primary outcome
Assess change in maximum reading speed in patients aged 8-16 years with moderate or severe visual impairment
Time frame: Perform test at first study visit (50 min duration), then let the patient use the SightPlus device for four weeks and then perform test again at the second study visit (70 min duration)
Maximum reading speed will be assessed using MNRead
Assess change in reading acuity in patients aged 8-16 years with moderate or severe visual impairment
Time frame: Perform test at first study visit (50 min duration), then let the patient use the SightPlus device for four weeks and then perform test again at the second study visit (70 min duration)
Reading acuity will be assessed using MNRead
Assess change in binocular visual acuity in patients aged 8-16 years with moderate or severe visual impairment
Time frame: Perform test at first study visit (50 min duration), then let the patient use the SightPlus device for four weeks and then perform test again at the second study visit (70 min duration)
Binocular visual acuity will be measured using Keeler Crowded logMAR
Assess change in near visual acuity in patients aged 8-16 years with moderate or severe visual impairment
Time frame: Perform test at first study visit (50 min duration), then let the patient use the SightPlus device for four weeks and then perform test again at the second study visit (70 min duration)
Near visual acuity will be measured using Sloan reduced logMAR
Assess change in contrast sensitivity in patients aged 8-16 years with moderate or severe visual impairment
Time frame: Perform test at first study visit (50 min duration), then let the patient use the SightPlus device for four weeks and then perform test again at the second study visit (70 min duration)
Contrast Sensitivity will be measured using the Evans Low Contrast Sensitivity test
Assess change in facial expressions in patients aged 8-16 years with moderate or severe visual impairment
Time frame: Perform test at first study visit (50 min duration), then let the patient use the SightPlus device for four weeks and then perform test again at the second study visit (70 min duration)
Facial expressions will be assessed using the NimStim Dataset and the number of errors will be counted
Assess change in vision-related quality of life in patients aged 8-16 years with moderate or severe visual impairment
Time frame: Ask patients to complete the baseline questionnaire immediately after the first visit at home and to complete the post-trial questionnaire at home at end of the four week trial period (with the Sightplus device) and return this at the 2nd clinic visit
Patients will asked to complete baseline and post-trial vision-related quality of life questionnaires.
Assess change in functional vision in patients aged 8-16 years with moderate or severe visual impairment
Time frame: Ask patients to complete the baseline questionnaire immediately after the first visit at home and to complete the post-trial questionnaire at home at end of the four week Sightplus device trial period and return this at the 2nd clinic visit
Patients will asked to complete baseline and post-trial functional vision questionnaires.
Determine how and when patients aged 8-16 years with moderate or severe visual impairment use the SightPlus device
Time frame: The home diary is completed by the patient at home during the four week trial of the SightPlus device when it is used. The home diary is returned during the second visit to the clinic
Patients will be given a home diary to complete during the four week trial using the SightPlus device.
Determine usability and acceptability of Sightplus device
Time frame: Patients and parents/carers will be given usability/acceptability feedback form to complete at home at the end of the four-week trial period. They will return this at the second clinic visit
Patients and parents/carers will be given a usability/acceptability feedback form to complete
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Finnguala Burgum principal investigator
Sheffield Children's NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SightPlus in people with Vision Disability, run by Sheffield Children's NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess change in maximum reading speed in patients aged 8-16 years with moderate or severe visual impairment (time frame: Perform test at first study visit (50 min duration), then let the patient use the SightPlus device for four weeks and then perform test again at the second study visit (70 min duration)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2022.