About this trial
The goal of this observational study is to define visual frailty and refine monitoring for an ageing population. It involves piloting a visual frailty assessment tool in a cohort of patients aged 60 and above with a known diagnosis of Age-related Macular Degeneration (AMD) in Princess Alexandra Eye Pavilion (PAEP), Anne Rowling Clinic which is hosting the NHS Low Visual Aid Clinic, or any other NHS Lothian facility treating patients with Age-related Macular Degeneration (AMD). The main questions it aims to answer are:
* What is visual frailty and how can it be assessed or predicted in the global ageing population using visual acuity, reading performance, functional status, mental health and systemic co-morbidities? * What is the relationship between visual acuity, reading performance, ocular diagnosis, co-morbidities, mental health, and functional status?
Participants will have the following data collected from them from either Princess Alexandra Eye Pavilion, Anne Rowling Clinic which is hosting the NHS Low Visual Aid Clinic, or any other NHS Lothian facility treating patients with Age-related Macular Degeneration (AMD):
* Visual acuity (both distance and near) * Reading performance * Functional status * Mental health * Co-morbidities
Data will also be collected remotely (by phone call) from both the participants and their carers/relatives about their perceptions of visual frailty.
Expert opinion will be sought from optometrists and ophthalmologists about the concept of visual frailty using an online survey.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participants should be residents of Scotland aged 60 years and above with a known diagnosis of advanced AMD.
The patients should be receiving treatment from Princess Alexandra Eye Pavilion (PAEP) for at least 6 months and should be responding positively to the treatment. This is to rule out poor results due to either not receiving medication or non-compliance.
The participants should be able to provide informed consent before taking part in the study.
Disqualifiers
Participants who cannot speak and read English language will not be included in this pilot study. However, non-English speakers will be included in the future together with interpreters at the validation phase of the developed tool.
Participants who have undergone invasive ocular surgery like cataract extraction in their previous visit.
The potential participants who fail to provide or do not provide informed consent will not be included in the study.
Trial population
Participants aged 60 and above with a known diagnosis of advanced Age-related Macular Degeneration (AMD) will be recruited from Princess Alexandra Eye Pavilion (PAEP) macular clinic. Their relatives or carers will also participate in the study but their data will be collected remotely. The term relatives/carers will be restricted to spouses/partners or children of the patients with advanced AMD.
Trial design
Case-only
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Visual frailty
This will be assessed in units of visual frailty index. This is a pilot study and the visual frailty index will be derived from the results from the outcomes measures described below. These outcome measures include visual acuity, reading performance, functional status, mental health, and co-morbidities.
Secondary outcomes
Visual acuity
Visual acuity will be assessed using logMAR charts and will be recorded in logMAR units.
Reading performance
To be assessed using Digital Radner. The results will be recorded in terms of reading speed (measured in words per minute) and reading acuity (measured in logRAD)
Functional status
To be assessed using Lawton and Brody Instrumental Activities of Daily Living scale. The score on this scale ranges from 0 to 8 for women and 0 to 5 for men. The lower value (0) corresponds to low function or being dependent while the highest values (8 or 5) correspond to high function or being independent.
Mental health (Depression)
This will be assessed using Patient Health Questionnaire -9 tool. The scores are classified as: 1-4: Minimal depression; 5-9: Mild depression; 10-14: Moderate depression; 15-19: Moderately severe depression; and 20-27: Severe depression
Sponsors and contacts
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University of Edinburgh
Lead sponsor
NHS Lothian
Collaborator