Irreversible Vision LossNCT07317180
Meta Glasses for Low Vision
A study testing Meta AI Glasses in people with Irreversible Vision Loss, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial summary
Visual impairment, particularly from glaucoma and retinal dystrophies, significantly hinders mobility and increases the risk of falls, leading to decreased independence and mental health challenges. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Irreversible Vision Loss
- What is being tested?
- Meta AI Glasses
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Confirmed diagnosis of glaucoma, retinal dystrophy, or another condition associated with legal blindness.
- Presence of documented irreversible vision loss
- No surgical or laser procedures in the last 6 months
- Visual field worse than 12db or poor visual acuity 20/400 or worse
Who cannot join
- Has no access to telephone
- Unable to speak English
- Has previously received comprehensive low vision services
- 5. Has history of stroke with aphasia 6. Has other health condition that would preclude follow-up (e.g., significant malignancy or life-threatening disease) 7. Is unable or unwilling to attend clinic visits required for the study 8. Reports significant loss of vision since last eye exam
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: The Use of Meta AI Glasses With Be My Eyes Network to Improve Mobility in Patients With Low Vision
Visual impairment, particularly from glaucoma and retinal dystrophies, significantly hinders mobility and increases the risk of falls, leading to decreased independence and mental health challenges. Current low-vision assistive technologies primarily focus on near-task magnification for reading, leaving a critical gap in tools designed to assist with real-world navigation and peripheral vision loss. To address this, the proposed research evaluates Meta AI glasses, which offer real-time scene narration and object recognition, integrated with the Be My Eyes network. The study hypothesizes that this wearable AI technology will improve ambulation, orientation, and overall quality of life for patients, providing a functional solution for mobility that traditional devices lack.
Read the detailed description
Background
Visual impairment, including both low vision and blindness, ranks among the 10 most prevalent causes of disability in North America1. Glaucoma causes irreversible vision loss, and treatments are only available to prevent disease onset and progression, but no cure is available.2. Patients with vision loss have impairments in both physical and mental health, thus limiting their activities of daily living (ADLs).3 In turn, these patients exhibit a decreased quality of life which can result in lowered self-esteem and depression.4,5 In patients with glaucoma, functional loss often begins with glare sensitivity, mobility and difficulty ambulating.5 Due to decreased peripheral vision, patients tend to have an increased risk of accidents and falls. One study found that glaucoma patients walked up to 10% slower than those without glaucoma4. In turn, these patients experienced almost twice as many bumps, stumbles and orientation issues as compared to non-glaucomatous patients.6
Low visual acuity significantly impairs mobility in patients with retinal dystrophies, as it reduces the ability to detect obstacles, navigate unfamiliar environments, and maintain safe ambulation, especially under variable lighting conditions. Performance-based assessments such as the multi-luminance mobility test (MLMT) demonstrate that reduced visual acuity, along with diminished visual field and contrast sensitivity, correlates with slower travel speed, increased collisions, and greater difficulty in orientation and navigation tasks in real-world settings.7,8
Rationale for the Proposed Research
Although a range of low-vision devices is currently available, none are explicitly designed to address mobility as a primary functional outcome. Existing technologies largely target near tasks through optical magnification, providing support for seated reading but offering limited benefit for individuals whose major challenges stem from peripheral visual field loss or real-world navigation difficulties, an unmet need in patients with glaucoma and many inherited retinal disorders.
In contrast, Meta AI glasses represent a new class of wearable assistive technology with capabilities that extend far beyond magnification. These glasses integrate real-time scene narration, environmental description, object recognition, and access to remote human assistance, offering dynamic support across diverse and mobile settings. Their onboard sensors and AI-driven interface also create the possibility of functional visual field assessment and continuous contextual guidance features fundamentally different from traditional low vision devices.
While these devices, known as Meta AI glasses, are gradually becoming more integrated into clinical care, no formal study has yet evaluated their specific impact on mobility in patients with low vision. Understanding whether AI-enhanced wearable devices can improve ambulation, orientation, and functional independence in low vision patients represents an important next step in advancing both clinical practice and patient outcomes.
This proposal aims to evaluate the performance and impact on the quality of life of Meta AI glasses in patients with low vision.
Hypothesis
Use of Meta AI Glasses integrated with the Be My Eyes network will improve mobility and quality of life in patients with low vision.
Objectives
The principal objective of this study is to evaluate the utility of Meta AI Glasses integrated with the Be My Eyes network on mobility in patients with significantly restricted visual fields or low visual acuity.
Specific Aim:
Mobility: To assess whether use of the device improves ambulation, orientation, and navigation safety in real-world .
- Project design, methodology and analysis This study will be conducted at the Ivey Eye Institute at St. Joseph's Health Care in London, Ontario. Eligible patients with a documented visual field loss will be identified from ophthalmology practices within the institute.
The following inclusion and exclusion criteria will be implemented:
Inclusion criteria:
- Confirmed diagnosis of glaucoma, retinal dystrophy, or another condition associated with legal blindness.
- Presence of documented irreversible vision loss
- No surgical or laser procedures in the last 6 months
- Visual field worse than 12db or poor visual acuity 20/400 or worse
Exclusion criteria:
- Has no access to telephone
- Unable to speak English
- Has previously received comprehensive low vision services
- Has history of stroke with aphasia 6. Has other health condition that would preclude follow-up (e.g., significant malignancy or life-threatening disease) 7. Is unable or unwilling to attend clinic visits required for the study 8. Reports significant loss of vision since last eye exam
Participants will be randomized into two groups:
- Intervention group: 25 Patients receiving standard care for their eye condition will be provided with customized Meta AI Glasses integrated with the Be My Eyes network. Each patient will receive training on device use, followed by an adaptation period where they incorporate the glasses into their daily activities.
- Control group: 25 Patients will continue receiving standard care and will not receive the Meta AI glasses during the study period.
The randomization will be conducted in a 1:1 ratio to either the intervention group (Meta AI Glasses + Be My Eyes) or the control group (usual low-vision care). Randomization will be performed using a computer-generated sequence with allocation concealment through a centralized system. Outcome assessors and data analysts will remain masked to group assignment, and analyses will follow the intention-to-treat principle.
- Conditions
- Irreversible Vision Loss
- Being tested
- Meta AI Glasses, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meta AI GlassesOther
Meta AI glasses in patients with low vision
ControlOther
25 Patients will continue receiving standard care and will not receive the Meta AI glasses during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Meta AI Glasses | Experimental | 25 Patients receiving standard care for their eye condition will be provided with customized Meta AI Glasses integrated with the Be My Eyes network. Each patient will receive training on device use, followed by an adaptation period where they incorporate the glasses into their daily activities. Receives: Other: Meta AI Glasses |
| Control | Sham comparator | Control group: 25 Patients will continue receiving standard care and will not receive the Meta AI glasses during the study period. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
patient-reported vision-targeted quality of life
The primary outcome will be change in patient-reported vision-targeted quality of life, measured using the National Eye Institute Visual Function Questionnaire - 25 item (NEI VFQ-25).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible Vision LossStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Monali Malvankar, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07317180
- Sponsor's protocol ID
- 128336
- Status last verified
- Dec 2025
- First submitted
- 19 Dec 2025
- Last updated
- 5 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IP will not be shared because it is not allowed by the Western Research Ethics Board and the Lawson Research Institute REB committee.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Meta AI Glasses With Be My Eyes Network to Improve Mobility in Patients With Low Vision
- ClinicalTrials.gov ID
- NCT07317180
- Acronym / sponsor ID
- 128336
- Conditions
- Irreversible Vision Loss
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 5 Jan 2026 (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.
Visual impairment, particularly from glaucoma and retinal dystrophies, significantly hinders mobility and increases the risk of falls, leading to decreased independence and mental health challenges. Current low-vision assistive technologies primarily focus on near-task magnification for reading, leaving a critical gap in tools designed to assist with real-world navigation and peripheral vision loss. To address this, the proposed research evaluates Meta AI glasses, which offer real-time scene narration and object recognition, integrated with the Be My Eyes network. The study hypothesizes that this wearable AI technology will improve ambulation, orientation, and overall quality of life for patients, providing a functional solution for mobility that traditional devices lack.
Detailed description
Background
Visual impairment, including both low vision and blindness, ranks among the 10 most prevalent causes of disability in North America1. Glaucoma causes irreversible vision loss, and treatments are only available to prevent disease onset and progression, but no cure is available.2. Patients with vision loss have impairments in both physical and mental health, thus limiting their activities of daily living (ADLs).3 In turn, these patients exhibit a decreased quality of life which can result in lowered self-esteem and depression.4,5 In patients with glaucoma, functional loss often begins with glare sensitivity, mobility and difficulty ambulating.5 Due to decreased peripheral vision, patients tend to have an increased risk of accidents and falls. One study found that glaucoma patients walked up to 10% slower than those without glaucoma4. In turn, these patients experienced almost twice as many bumps, stumbles and orientation issues as compared to non-glaucomatous patients.6
Low visual acuity significantly impairs mobility in patients with retinal dystrophies, as it reduces the ability to detect obstacles, navigate unfamiliar environments, and maintain safe ambulation, especially under variable lighting conditions. Performance-based assessments such as the multi-luminance mobility test (MLMT) demonstrate that reduced visual acuity, along with diminished visual field and contrast sensitivity, correlates with slower travel speed, increased collisions, and greater difficulty in orientation and navigation tasks in real-world settings.7,8
Rationale for the Proposed Research
Although a range of low-vision devices is currently available, none are explicitly designed to address mobility as a primary functional outcome. Existing technologies largely target near tasks through optical magnification, providing support for seated reading but offering limited benefit for individuals whose major challenges stem from peripheral visual field loss or real-world navigation difficulties, an unmet need in patients with glaucoma and many inherited retinal disorders.
In contrast, Meta AI glasses represent a new class of wearable assistive technology with capabilities that extend far beyond magnification. These glasses integrate real-time scene narration, environmental description, object recognition, and access to remote human assistance, offering dynamic support across diverse and mobile settings. Their onboard sensors and AI-driven interface also create the possibility of functional visual field assessment and continuous contextual guidance features fundamentally different from traditional low vision devices.
While these devices, known as Meta AI glasses, are gradually becoming more integrated into clinical care, no formal study has yet evaluated their specific impact on mobility in patients with low vision. Understanding whether AI-enhanced wearable devices can improve ambulation, orientation, and functional independence in low vision patients represents an important next step in advancing both clinical practice and patient outcomes.
This proposal aims to evaluate the performance and impact on the quality of life of Meta AI glasses in patients with low vision.
Hypothesis
Use of Meta AI Glasses integrated with the Be My Eyes network will improve mobility and quality of life in patients with low vision.
Objectives
The principal objective of this study is to evaluate the utility of Meta AI Glasses integrated with the Be My Eyes network on mobility in patients with significantly restricted visual fields or low visual acuity.
Specific Aim:
Mobility: To assess whether use of the device improves ambulation, orientation, and navigation safety in real-world .
- Project design, methodology and analysis This study will be conducted at the Ivey Eye Institute at St. Joseph's Health Care in London, Ontario. Eligible patients with a documented visual field loss will be identified from ophthalmology practices within the institute.
The following inclusion and exclusion criteria will be implemented:
Inclusion criteria:
- Confirmed diagnosis of glaucoma, retinal dystrophy, or another condition associated with legal blindness.
- Presence of documented irreversible vision loss
- No surgical or laser procedures in the last 6 months
- Visual field worse than 12db or poor visual acuity 20/400 or worse
Exclusion criteria:
- Has no access to telephone
- Unable to speak English
- Has previously received comprehensive low vision services
- Has history of stroke with aphasia 6. Has other health condition that would preclude follow-up (e.g., significant malignancy or life-threatening disease) 7. Is unable or unwilling to attend clinic visits required for the study 8. Reports significant loss of vision since last eye exam
Participants will be randomized into two groups:
- Intervention group: 25 Patients receiving standard care for their eye condition will be provided with customized Meta AI Glasses integrated with the Be My Eyes network. Each patient will receive training on device use, followed by an adaptation period where they incorporate the glasses into their daily activities.
- Control group: 25 Patients will continue receiving standard care and will not receive the Meta AI glasses during the study period.
The randomization will be conducted in a 1:1 ratio to either the intervention group (Meta AI Glasses + Be My Eyes) or the control group (usual low-vision care). Randomization will be performed using a computer-generated sequence with allocation concealment through a centralized system. Outcome assessors and data analysts will remain masked to group assignment, and analyses will follow the intention-to-treat principle.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meta AI Glasses | Experimental | Other: Meta AI Glasses25 Patients receiving standard care for their eye condition will be provided with customized Meta AI Glasses integrated with the Be My Eyes network. Each patient will receive training on device use, followed by an adaptation period where they incorporate the glasses into their daily activities. |
| Control | Sham comparator | Other: ControlControl group: 25 Patients will continue receiving standard care and will not receive the Meta AI glasses during the study period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Confirmed diagnosis of glaucoma, retinal dystrophy, or another condition associated with legal blindness.
- Presence of documented irreversible vision loss
- No surgical or laser procedures in the last 6 months
- Visual field worse than 12db or poor visual acuity 20/400 or worse
Key exclusion criteria (4 listed)
- Has no access to telephone
- Unable to speak English
- Has previously received comprehensive low vision services
- 5. Has history of stroke with aphasia 6. Has other health condition that would preclude follow-up (e.g., significant malignancy or life-threatening disease) 7. Is unable or unwilling to attend clinic visits required for the study 8. Reports significant loss of vision since last eye exam
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 |
|---|---|---|
| Meta AI GlassesMeta AI glasses in patients with low vision | Other | Meta AI Glasses |
| Control25 Patients will continue receiving standard care and will not receive the Meta AI glasses during the study period. | Other | Control |
Primary outcome
patient-reported vision-targeted quality of life
Time frame: 4 weeks
The primary outcome will be change in patient-reported vision-targeted quality of life, measured using the National Eye Institute Visual Function Questionnaire - 25 item (NEI VFQ-25).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No. IP will not be shared because it is not allowed by the Western Research Ethics Board and the Lawson Research Institute REB committee.
Related trials for Irreversible Vision Loss
Not yet recruiting
Health Education vs Meditation in Irreversible Age-Related Vision Loss Patients and Their Caregivers
Low Vision, One Eye, Unspecified Eye, Low Vision Blindness
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.
Questions about this trial
What is this clinical trial studying?
A study testing Meta AI Glasses in people with Irreversible Vision Loss, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monali Malvankar (519-685-8500 ext. 61288, mmalvan@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
patient-reported vision-targeted quality of life (time frame: 4 weeks). 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 5 Jan 2026.