Exploring the benefits of wearable electronic vision enhancement systems for people with age-related loss of central vision

Exploring the benefits of wearable electronic vision enhancement systems for people with age-related macular degeneration. A randomised crossover trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16865847

Enrollment

Registered

2023-03-30

Start date

2023-04-01

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

People with age-related macular degeneration as the principal cause of vision impairment. Eye Diseases

Interventions

This is a 16-week crossover study to assess the effect of adding a wearable electronic vision enhancement system (wEVES) to participants' existing prescribed and purchased low-vision solutions. The Ey

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. People who are aged 18 years or over 2. Vision loss primarily due to AMD and affects their daily life 3. Able to undertake assessments in English 4. Pass on the short form Mini-mental State Evaluation (MMSE: adapted for vision loss). 5. Not a current wEVES user

Exclusion criteria

Exclusion criteria: 1. Under 18 years of age 2. Other forms of maculopathy or significant causes of vision impairment 3. Reported significant deterioration in vision in the two months before entry 4. Planned curative ocular surgery (e.g. cataract operation) in the study time 5. Balance-related disorders 6. Hearing loss significant enough to affect answering telephone questions

Design outcomes

Primary

Measure	Time frame
The following primary outcome measurements will be taken at baseline, week 8 and week 16: 1. Activity limitation, task importance, and the participants' preferred solution measured using The Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ-48) 2. Vision-related quality of life measured using the Vision-related quality of life Core Measure (VCM1) 3. Vision-related utility instrument assessing gains in health-related quality of life measured using the Vision and Quality of Life Index (VisQoL)	—

Measure

Time frame

The following primary outcome measurements will be taken at baseline, week 8 and week 16: 1. Activity limitation, task importance, and the participants' preferred solution measured using The Veterans Affairs Low Vision Visual Functioning Questionnaire (VA LV VFQ-48) 2. Vision-related quality of life measured using the Vision-related quality of life Core Measure (VCM1) 3. Vision-related utility instrument assessing gains in health-related quality of life measured using the Vision and Quality of Life Index (VisQoL)

—

Secondary

Measure	Time frame
1. Adverse effects of the wearable electronic vision enhancement system (wEVES) measured using the Virtual Reality sickness questionnaire (VRSQ) at baseline, week 8 and week 16. 2. Participants' willingness to pay and qualitative thoughts about the device's strengths and weaknesses will be measured using a bespoke questionnaire at week 16	—

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026