An observational study in Frailty, Age-Related Macular Degeneration and Functional Status, sponsored by University of Edinburgh. Recruiting at 2 sites in United Kingdom. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by University of Edinburgh · Observational
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:
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):
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.
This is a mixed methods observational cross-sectional study that will consist of designing a tool to measure visual frailty and piloting it in a cohort of participants in the ageing population. The study will be implemented over a period of three years: literature review to define visual frailty and designing of the tool in the first year, recruitment of participants and performing a pilot and a validation study in the second year and thesis write-up in the final year.
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, 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 visual frailty index will consist of results from visual acuity, reading performance, functional status, mental health and co-morbidities. This tool will be piloted in a cohort of 20 patients with advanced AMD. The internal consistency of the tool will be determined at this phase of the project.
In addition to visual frailty, physical frailty will also be assessed in this cohort to enable analysis and establishment of the relationship between the two.
The patients with AMD and their relatives/carers will be invited to participate in remote data collection about their perspectives on visual frailty.
Best corrected distance and near visual acuity will be assessed and recorded. Reading performance will consist of reading speed and reading acuity which will be automatically measured using Digital Radner that will be acquired and installed before the implementation of the study.
Functional status will be assessed using Lawton and Brody Instrumental Activities of Daily Living (IADL) Scale.
Mental health will consist of depression, anxiety, and cognitive impairment that will be assessed using General Anxiety Disorder-7 (GAD-7), Patient Health Questionnaire-9 (PHQ-9), and Six-item Cognitive Impairment Test (6-CIT) respectively. All these are validated tools.
Physical frailty will be assessed using the FRAIL scale which relies on functions of fatigue, resistance, ambulation, illnesses and loss of weight.
Information about co-morbidities will be retrieved from the patients' health record through National Health Service (NHS) Lothian.
The data to be collected remotely from both the patients and their relatives/carers will be done through a phone call which will be scheduled during the hospital appointment. These calls will be recorded for analysis. They will then be transcribed verbatim, coded, and themes will be generated during the analysis.
In addition to defining and designing a tool to measure visual frailty, expert input will be sought from optometrists and ophthalmologists about this topic using an online survey.
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.
Exclusion Criteria:
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.
Time frame: Within the first day of enrollment into the study.
Visual acuity
Visual acuity will be assessed using logMAR charts and will be recorded in logMAR units.
Time frame: Within the first day of enrollment into the study.
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)
Time frame: Within the first day of enrollment into the study.
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.
Time frame: Within the first day of enrollment into the study.
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
Time frame: Within the first day of enrollment into the study.
Mental health (Anxiety)
This will be assessed using the Generalized Anxiety Disorder - 7 tool. The scores are classified as: 0-4: Minimal anxiety; 5-9: Mild anxiety; 10-14: Moderate anxiety; and 15-21: Severe anxiety
Time frame: Within the first day of enrollment into the study.
Mental health (Cognitive Impairment)
This will be assessed using the 6-item Cognitive Impairment Test. The score ranges from 0 to 28 in which 0-7 are considered normal and 8 or more are considered to be more significant.
Time frame: Within the first day of enrollment into the study.
Co-morbidities
These will be collected from the medical records of participants and a simple count of the conditions will be used.
Time frame: Within the first day of enrollment into the study.
Physical frailty
This will be assessed using the frail scale which relies on functions of fatigue, resistance, ambulation, illnesses and loss of weight. The scores range from 0 to 5. A score of 0 represents robust health status; 1-2 means participant is pre-frail; and 3-5 means the participant is Frail.
Time frame: Within the first day of enrollment into the study.
Correlation between visual frailty and physical frailty
Results of visual frailty and physical frailty will be analysed to establish the correlation between the two.
Time frame: This will be done immediately after assessment of both visual frailty and physical on the first day.
Correlation between Age-related macular degeneration and frailty
Age-related macular degeneration stage will be retrieved from the medical records and frailty will be assessed using the FRAIL scale which relies on functions of fatigue, resistance, ambulation, illnesses and loss of weight.
Time frame: This will be done immediately after assessment of physical frailty on the first day.
Perception about visual frailty
This qualitative data will be remotely collected through a phone call from both the patients with AMD and their relatives/carers
Time frame: Within 4 weeks from the assessment date of visual frailty.
Expert opinion about visual frailty
This will be collected via an online survey from optometrists and ophthalmologists.
Time frame: From enrolment to the end of the study, an average of approximately 3 months.
Plan to share: Yes — The anonymised data from the results section will be made available.
Supporting information: Study protocol, Icf
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