Visual ImpairmentsNCT07827040
Effectiveness of a Multi-disciplinary Vision Rehabilitation Programme in Improving the Overall Quality of Life of Visually Impaired Adults
A study testing Multidisciplinary vision rehabilitaion and Vision rehabilitation incorporating low vision training only in people with Visual Impairments and Low Vision Digital Assistance, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
Trial summary
This trial compares multidisciplinary vision rehabilitation and vision rehabilitation services to determine which service works better at improving overall quality of life for adults with visual impairment. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Visual Impairments, Low Vision Digital Assistance, Adults
- What is being tested?
- Multidisciplinary vision rehabilitaion and Vision rehabilitation incorporating low vision training only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 1 siteHong Kong
- Study dates
- 29 Sep 2026to 30 Sep 2029
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 and 80 years
- Community-dwelling in Hong Kong
- Cantonese Speaker
- Clinical diagnosis of low vision (best-corrected visual acuity <6/18; and/or field loss of < 20 degree)
- Stable ocular condition for ≥ 3 months
- Owns a smartphone
Show all 9Show fewer
- Not currently participating in any vision rehabilitation programme
- Willing to participate and commit for at least 6 months to 12 months
- Provides informed consent
Who cannot join
- Living in a nursing home/ institutionalized
- Self-reported severe cognitive impairment or HK-MoCA-VI cut off score of 12
- Self-reported severe hearing impairment
- Uncontrolled systemic ocular diseases/ neurological or psychiatric conditions
- Immobility caused by physical impairment
- Refuse to provide written informed consent
- Participating in another vision rehabilitation programme during the trial period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
School of Optometry, The Hong Kong Polytechnic University
Kowloon, Hung Hom
Ming-Yan Allen Cheong, PhD, +852 2766 6108, allen.my.cheong@polyu.edu.hk
Wing Yan Lau, PhD, +852 2766 4462, ingrid.lau@polyu.edu.hk
About this study
Official title: Effectiveness of a Multi-disciplinary Vision Rehabilitation Programme in Improving Function and Quality of Life of Visually Impaired Patients: a Randomized Controlled Trial
This trial compares multidisciplinary vision rehabilitation and vision rehabilitation services to determine which service works better at improving overall quality of life for adults with visual impairment. Before receiving the intervention, participants will complete baseline measurements, including an eye examination, cognitive and hearing screenings, mobility and balance assessments, questionnaires on basic demographics and health, and a home environment assessment. This randomised controlled trial includes three arms: 1) control-waitlist (wait for 3 months before joining either intervention arm), 2) vision rehabilitation with low vision training only, and 3) multidisciplinary vision rehabilitation arm.
The intervention period lasts for eight weeks, comprising of four on-site training sessions.
- During the intervention period, all participants will receive low-vision training on the use of advanced assistive technology.
- Those in the multidisciplinary group will also receive counselling, exercise training, and home assessment with home modifications (if needed).
- Conditions
- Visual Impairments, Low Vision Digital Assistance, Adults
- Being tested
- Multidisciplinary vision rehabilitaion, Vision rehabilitation incorporating low vision training only
- Keywords
- low vision, advanced assistive technology, vision rehabilitation
- Medical subject headings
- Vision Disorders, Vision, Low
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidisciplinary vision rehabilitaionOther
A holistic approach to provide vision rehabilitation services, including low vision training incorporating advanced assistive technology, home-based exercise training, counselling and home assessment with home modification. The intervention lasts for eight weeks. On-site, group-based training sessions are provided for low vision training (1 hour), exercise training (1 hour), and solution-focused therapy (1.5 hours). Low vision training components are identical to the components received in the vision rehabilitation (low vision component) arm. Exercise training focuses on strengthening lower-limb muscles designed to reduce risk of falls. Solution-focused therapy focuses on helping participants build solutions to visual impairment problems and facilitate their development of preferred futures. Participants will receive minor home modifications, if needed, after the home assessment.
Vision rehabilitation incorporating low vision training onlyOther
This intervention includes providing vision rehabilitation that incorporates advanced assistive technology to support daily living. The intervention lasts for eight weeks, which includes four on-site training sessions (1 hour each). The group-based training includes an introduction to operating smart glasses and AI assistant applications on mobile devices, and offers scenario-based training on utilising these advanced assistive technologies to perform daily activities.
| Study group | Role | What they receive |
|---|---|---|
| Control waitlist | No intervention | Participants will wait for 3 months before receiving intervention |
| Vision rehabilitation arm | Experimental | Participants assigned to the Vision rehabilitation arm will only receive the low vision training on the use of advanced assistive technology. Group-based training will be provided. Receives: Other: Vision rehabilitation incorporating low vision training only |
| Multidisciplinary vision rehabilitation | Experimental | Multidisciplinary vision rehabilitation includes group-based low-vision training, group-based solution-focused therapy, group-based exercise training, and home assessment with home modification (if needed). Receives: Other: Multidisciplinary vision rehabilitaion |
What is being measured
The primary outcome is the main question the study is designed to answer.
General-health related quality of life
General health related quality of life will be measured using the Hong Kong version of the EuroQoL 5-Dimension instrument 5-level (EQ-5D-5L-HK). Five aspects will be meausred including mobility, self-care, usual activities, pain/discomport, anxiety/depression. A scale of 1 to 5 will be rated. The participant will also be asked to give an overall score for their health at the time of measurement, which is out of 100, 0 means poorest
Measured: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Vision-related quality of life
Vision-related quality of life will be measured by the Low Vision Visual Functioning Questionnaire 48 (LV VFQ-48). The LV VFQ48 was translated into Traditional Chinese. LV VFQ-48 measures the difficulties in performing daily activities.
Measured: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Secondary outcomes (10)
Visual function
Visual function will be measured using the Melbourne Low-Vision ADL Index (MLVAI). It includes 17 functional performance measures and 9 self-reported questions related to real-world daily activities. The original 17-item functional tasks in MLVAI were modified to align with the local context. Item descriptions were translated into Traditional Chinese. The scoring system has been revised to include quantifiable completion time to improve the reliability of performance scoring between assessors. Baseline assessment will collect two types of data: the original performance using habitual glasses and the performance score using a mobile phone (with any assistive functions enabled). The post-intervention assessment will collect performance scores using the advanced assistive technology prescribed to the participants during the intervention (i.e., smart glasses and/or an AI assistant on their mobile phone).
Measured: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Level of hope (psychological wellbeing)
The level of hope is measured by the Herth Hope Index (HHI). This index includes 12 self-reported items, covering three subscales "Sense of temporality and future", "Positive readiness and expectancy", and "Interconnectedness with self and others". Each item is rated on a 4-point Likert scale, where 1 indicates strongly disagree, and 4 indicates strongly agree. The total score can range from 12 to 48. The higher the score, the greater the level of hope.
Measured: Changes from baseline and within one month after the completion of an eight-week intervention.
Depression severity (psychological wellbeing)
Depression severity is measured using the Patient Health Questionnaire (PHQ-9) . The PHQ-9 comprises nine questions, along with an impact question measuring the extent to which depressive symptoms affect daily functioning. Depression severity is measured over a two-week period. The frequency of the symptoms is rated on a four-point scale, where 0 = "Not at all", 1 = "several days", 2 = "More than half of the days", and 3 = "Nearly every day". The total score can range from 0 to 27. A higher PHQ-9 score indicates higher depressive severity. A cutoff score of 20 or above indicates severe depression.
Measured: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Anxiety severity (Psychological wellbeing)
Severity of anxiety is assessed using the Generalised Anxiety Disorder-7 (GAD-7). GAD-7 includes seven questions along with one impact question. On a four-level scale, GAD-7 captures the frequency of anxiety symptoms experienced over the past two-week period. Each question is rated on a four-point scale, where 0 = "Not at all", 1 = "Several days", 2 = "More than half the days", 3 = "Nearly every day". The total score can range from 0 to 21. The higher the GAD-7 score, the higher the level of anxiety. A cutoff score of 15 or above indicates a severe level of anxiety.
Measured: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Balance and mobility functions
Balance and mobility function will be measured using the Mini Balance Evaluation System Test (miniBesTest). This is a 14-item assessment. Each item is scored on a three-point ordinal scale, with 0 indicating severe impairment in performance, 1 indicating moderate impairment in performance, and 2 indicating normal performance. The 14 items cover anticipatory postural adjustments, reactive postural control, sensory orientation, and dynamic gait. The highest possible score is 28, with a score of 21 or below indicating an elevated risk of falls. The performance of the miniBesTest is video-recorded.
Measured: Changes in measurement from Baseline to within one month after the completion of an eight-week intervention programme.
Mobility
The mobility function is assessed using the Narrow Path Walking Test (NPWT). The performance is scored based on the completion time (in seconds) taken to complete a six-metre-long path. A green mat measuring 40 x 300cm is used to divide a path into two 20-centimetre-wide pathways. The participants will be asked to stand up from a chair, walk around the green mat while avoiding stepping over the boundaries, and return to the chair at the starting point. Step errors are marked as those that step outside the boundaries. Three trials are allowed, and the average completion time will be used as final performance. The performance is video-recorded.
Measured: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Lower body functioning
This will be assessed by the 30-second Chair Stand Test. The participant will be asked to sit fully on a chair and rise to a full standing position as many times as possible within 30 seconds. During the assessment, they are not allowed to use their hands for assistance. The assessor will count the number of repetitions a participant can complete within 30 seconds. Anyone who uses their hands to stand up will be scored a "0".
Measured: Changes in measurement from Baseline to within one month after completion of an eight-week intervention
Fear of fall
Fear of fall is assessed using the Chinese-validated version of the 16-item Fall Efficacy Scale International (FES-I). Each item is rated on a four-point Likert scale, where 1 indicates not concerned and 4 indicates extremely concerned. The total score can range from 16 to 84. The higher the FES-I score, the higher the fear of falls. A cutoff score of 28 or higher indicates a higher risk of falls.
Measured: Changes in measurement from baseline to within one month after the completion of an eight-week intervention.
Awareness of fall protective behaviour
This is assessed by the 30-item Fall Behavioural Scale (FaB). Each item is rated on a four-level Likert scale, with 1 = "never", 2 = "sometimes", 3 = "often", 4 = "always", and an option of "not applicable". The higher the FaB score, the higher the use of protective behaviours.
Measured: Changes in measurement from baseline to within one month after the completion of an eight-week intervention.
Environmental fall hazards (home environement)
Fall hazard in home environment is assessed by the WestMead Home Safety Assessment (WeHSA). The WeHSA assessed a total of 72-item hazard categories across 13 areas at home, where applicable. The outcome measure is the number of hazards identified across these 13 areas.
Measured: Changes in measurement from baseline to within one month after the completion of an eight-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start29 Sep 2026 (estimated)
- Primary completion30 Aug 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual ImpairmentsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hong Kong Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Wu Jieh Yee Charitable Foundation
- Responsible party
- Principal investigator, Allen MY Cheong, The Hong Kong Polytechnic University
- Investigators
- Ming-Yan Allen Cheong, PhD, Principal investigator, The Hong Kong Polytechnic University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07827040
- Sponsor's protocol ID
- P0056196
- Status last verified
- Aug 2026
- First submitted
- 12 Sep 2026
- Last updated
- 18 Sep 2026
- 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Multi-disciplinary Vision Rehabilitation Programme in Improving Function and Quality of Life of Visually Impaired Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07827040
- Acronym / sponsor ID
- P0056196
- Conditions
- Visual Impairments, Low Vision Digital Assistance, Adults
- Keywords
- low vision, advanced assistive technology, vision rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The Hong Kong Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Wu Jieh Yee Charitable Foundation
- Study start
- 29 Sep 2026 (estimated)
- Primary completion
- 30 Aug 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 18 Sep 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.
This trial compares multidisciplinary vision rehabilitation and vision rehabilitation services to determine which service works better at improving overall quality of life for adults with visual impairment. Before receiving the intervention, participants will complete baseline measurements, including an eye examination, cognitive and hearing screenings, mobility and balance assessments, questionnaires on basic demographics and health, and a home environment assessment. This randomised controlled trial includes three arms: 1) control-waitlist (wait for 3 months before joining either intervention arm), 2) vision rehabilitation with low vision training only, and 3) multidisciplinary vision rehabilitation arm.
The intervention period lasts for eight weeks, comprising of four on-site training sessions.
- During the intervention period, all participants will receive low-vision training on the use of advanced assistive technology.
- Those in the multidisciplinary group will also receive counselling, exercise training, and home assessment with home modifications (if needed).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control waitlist | No intervention | –Participants will wait for 3 months before receiving intervention |
| Vision rehabilitation arm | Experimental | Other: Vision rehabilitation incorporating low vision training onlyParticipants assigned to the Vision rehabilitation arm will only receive the low vision training on the use of advanced assistive technology. Group-based training will be provided. |
| Multidisciplinary vision rehabilitation | Experimental | Other: Multidisciplinary vision rehabilitaionMultidisciplinary vision rehabilitation includes group-based low-vision training, group-based solution-focused therapy, group-based exercise training, and home assessment with home modification (if needed). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Aged 18 and 80 years
- Community-dwelling in Hong Kong
- Cantonese Speaker
- Clinical diagnosis of low vision (best-corrected visual acuity <6/18; and/or field loss of < 20 degree)
- Stable ocular condition for ≥ 3 months
Key exclusion criteria (7 listed)
- Living in a nursing home/ institutionalized
- Self-reported severe cognitive impairment or HK-MoCA-VI cut off score of 12
- Self-reported severe hearing impairment
- Uncontrolled systemic ocular diseases/ neurological or psychiatric conditions
- Immobility caused by physical impairment
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 |
|---|---|---|
| Multidisciplinary vision rehabilitaionA holistic approach to provide vision rehabilitation services, including low vision training incorporating advanced assistive technology, home-based exercise training, counselling and home assessment with home modification. The intervention lasts for eight weeks. On-site, group-based training sessions are provided for low vision training (1 hour), exercise training (1 hour), and solution-focused therapy (1.5 hours). Low vision training components are identical to the components received in the vision rehabilitation (low vision component) arm. Exercise training focuses on strengthening lower-limb muscles designed to reduce risk of falls. Solution-focused therapy focuses on helping participants build solutions to visual impairment problems and facilitate their development of preferred futures. Participants will receive minor home modifications, if needed, after the home assessment. | Other | Multidisciplinary vision rehabilitation |
| Vision rehabilitation incorporating low vision training onlyThis intervention includes providing vision rehabilitation that incorporates advanced assistive technology to support daily living. The intervention lasts for eight weeks, which includes four on-site training sessions (1 hour each). The group-based training includes an introduction to operating smart glasses and AI assistant applications on mobile devices, and offers scenario-based training on utilising these advanced assistive technologies to perform daily activities. | Other | Vision rehabilitation arm |
Primary outcome
General-health related quality of life
Time frame: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
General health related quality of life will be measured using the Hong Kong version of the EuroQoL 5-Dimension instrument 5-level (EQ-5D-5L-HK). Five aspects will be meausred including mobility, self-care, usual activities, pain/discomport, anxiety/depression. A scale of 1 to 5 will be rated. The participant will also be asked to give an overall score for their health at the time of measurement, which is out of 100, 0 means poorest
Vision-related quality of life
Time frame: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Vision-related quality of life will be measured by the Low Vision Visual Functioning Questionnaire 48 (LV VFQ-48). The LV VFQ48 was translated into Traditional Chinese. LV VFQ-48 measures the difficulties in performing daily activities.
10 secondary outcomes
Visual function
Time frame: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Level of hope (psychological wellbeing)
Time frame: Changes from baseline and within one month after the completion of an eight-week intervention.
Depression severity (psychological wellbeing)
Time frame: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Anxiety severity (Psychological wellbeing)
Time frame: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Balance and mobility functions
Time frame: Changes in measurement from Baseline to within one month after the completion of an eight-week intervention programme.
Mobility
Time frame: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
Lower body functioning
Time frame: Changes in measurement from Baseline to within one month after completion of an eight-week intervention
Fear of fall
Time frame: Changes in measurement from baseline to within one month after the completion of an eight-week intervention.
Awareness of fall protective behaviour
Time frame: Changes in measurement from baseline to within one month after the completion of an eight-week intervention.
Environmental fall hazards (home environement)
Time frame: Changes in measurement from baseline to within one month after the completion of an eight-week intervention
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 18 Sep 2026.
- 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.
Ming-Yan Allen Cheong, PhD principal investigator
The Hong Kong Polytechnic University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidisciplinary vision rehabilitaion and Vision rehabilitation incorporating low vision training only in people with Visual Impairments and Low Vision Digital Assistance, run by The Hong Kong Polytechnic University at 1 site in Hong Kong.
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 9 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: looking for participants now, as of the sponsor's last update on 18 Sep 2026. 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 Hong Kong. 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?
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 Ming-Yan Allen Cheong, PhD (+852 2766 6108, allen.my.cheong@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General-health related quality of life (time frame: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.). The study lists 2 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 18 Sep 2026.