An interventional study of Multidisciplinary vision rehabilitaion and Vision rehabilitation incorporating low vision training only in Visual Impairments, Low Vision Digital Assistance and Adults, sponsored by The Hong Kong Polytechnic University. Recruiting at 1 site in Hong Kong. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by The Hong Kong Polytechnic University · Not applicable, Interventional, and Health services research
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.
98 studies on the registry are indexed under Vision, Low; 23 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 60 across 78 interventional studies indexed under Vision, Low.
Browse Vision, Low studies →The Hong Kong Polytechnic University is the lead sponsor of 679 studies on the registry; 257 are open to participants now.
Compared within Vision, Low, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Vision Disorders. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will wait for 3 months before receiving intervention
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.
Other: Vision rehabilitation incorporating low vision training only
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).
Other: Multidisciplinary vision rehabilitaion
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.
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.
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
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
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.
Time frame: Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.
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).
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Changes in measurement from baseline to within one month after the completion of an eight-week intervention
fall incidence
The number of falls in the past 12 months, fall characteristics and consquences will be collected
Time frame: This outcome will be collected at baseline, within one month after completion of intervention, 3-month post intervention, 6-month post intervention, 9-month post intervention and 12-month post intervention.
advanced assistive technology adoption rate
The adoption rate is the proportion of people who are introduced to an advanced assistive device and agree to use the device during the intervention period. A binary outcome will be collected, i.e. yes/ no.
Time frame: The measurement will be taken at baseline.
advanced assistive technology continuation rate
The continuation rate of the intervention components will be recorded as a binary outcome, i.e. yes or no. We collect whether the participant continue to engage in execise training, use of AI glassess/ smartphone accessibility, after intervention period.
Time frame: Outcome measurement collected at 3 months post intervention, 6 month post intervention, and 12 month post intervention.
User satisfaction of assistive tehcnology
This will be assessed using the Chinese version of the Quebec User Evaluation of Satisfaction with Assistive Technology (C-QUEST). This survey has 12 statements focusing on the device domain (Dimension, weight, adjustment, safety, durability, simplicity of use, comfort, and effectiveness) and the service domain (delivery service, repair/servicing, professional service, and follow-up service). Each statement is rated on a scale from 1 to 5, with 1 = "not satisfied at all" to 5 = "very satisfied". The questionnaire will yield three scores: the sub-scores for the device and service domains, and the total C-QUEST score. The CQUEST score can range from 12 to 60. The higher the CQUEST score, the higher the satisfaction towards the prescribed assistive technology. Each participant is also required to identify the three most important items out of the 12 items.
Time frame: The outcome will be collected in the 4th week of the intervention period and within one month after the completion of the eight-week intervention.
Plan to share: No
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Start is estimated for Sep 2026; primary completion for Aug 2029, 35 months later.
Of 38 interventional studies with no phase under Vision, Low, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 56. This study's planned 35 months is above that.
How these figures are worked out, and which studies are left out of them.
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