NCT07827040

Brief 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. 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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable

Timeline
37mo left

Started Sep 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2026

Completed
11 days until next milestone

Study Start

First participant enrolled

September 29, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2029

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Last Updated

September 18, 2026

Status Verified

August 1, 2026

Enrollment Period

2.9 years

First QC Date

September 12, 2026

Last Update Submit

September 12, 2026

Conditions

Keywords

low visionadvanced assistive technologyvision rehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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

    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.

    Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.

Secondary Outcomes (10)

  • Visual function

    Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.

  • Level of hope (psychological wellbeing)

    Changes from baseline and within one month after the completion of an eight-week intervention.

  • Depression severity (psychological wellbeing)

    Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.

  • Anxiety severity (Psychological wellbeing)

    Changes in the measurement at Baseline and within one month after the completion of an eight-week intervention.

  • Balance and mobility functions

    Changes in measurement from Baseline to within one month after the completion of an eight-week intervention programme.

  • +5 more secondary outcomes

Other Outcomes (4)

  • fall incidence

    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 measurement will be taken at baseline.

  • advanced assistive technology continuation rate

    Outcome measurement collected at 3 months post intervention, 6 month post intervention, and 12 month post intervention.

  • +1 more other outcomes

Study Arms (3)

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.

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).

Other: Multidisciplinary vision rehabilitaion

Interventions

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.

Vision rehabilitation arm

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.

Multidisciplinary vision rehabilitation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Not currently participating in any vision rehabilitation programme
  • Willing to participate and commit for at least 6 months to 12 months
  • Provides informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Optometry, The Hong Kong Polytechnic University

Kowloon, Hung Hom, Hong Kong

RECRUITING

MeSH Terms

Conditions

Vision DisordersVision, Low

Condition Hierarchy (Ancestors)

Sensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ming-Yan Allen Cheong, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ming-Yan Allen Cheong, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 12, 2026

First Posted

September 18, 2026

Study Start

September 29, 2026

Primary Completion (Estimated)

August 30, 2029

Study Completion (Estimated)

September 30, 2029

Last Updated

September 18, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations