Visual Frailty in Ageing (VFiA)

March 2, 2026 updated by: University of Edinburgh

Seeing Through Their Eyes - Towards Defining Visual Frailty in Ageing

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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study 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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual frailty
Time Frame: Within the first day of enrollment into the study.
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.
Within the first day of enrollment into the study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: Within the first day of enrollment into the study.
Visual acuity will be assessed using logMAR charts and will be recorded in logMAR units.
Within the first day of enrollment into the study.
Reading performance
Time Frame: Within the first day of enrollment into the study.
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)
Within the first day of enrollment into the study.
Functional status
Time Frame: Within the first day of enrollment into the study.
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.
Within the first day of enrollment into the study.
Mental health (Depression)
Time Frame: Within the first day of enrollment into the study.
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
Within the first day of enrollment into the study.
Mental health (Anxiety)
Time Frame: Within the first day of enrollment into the study.
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
Within the first day of enrollment into the study.
Mental health (Cognitive Impairment)
Time Frame: Within the first day of enrollment into the study.
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.
Within the first day of enrollment into the study.
Co-morbidities
Time Frame: Within the first day of enrollment into the study.
These will be collected from the medical records of participants and a simple count of the conditions will be used.
Within the first day of enrollment into the study.
Physical frailty
Time Frame: Within the first day of enrollment into the study.
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.
Within the first day of enrollment into the study.
Correlation between visual frailty and physical frailty
Time Frame: This will be done immediately after assessment of both visual frailty and physical on the first day.
Results of visual frailty and physical frailty will be analysed to establish the correlation between the two.
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
Time Frame: This will be done immediately after assessment of physical frailty on the first day.
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.
This will be done immediately after assessment of physical frailty on the first day.
Perception about visual frailty
Time Frame: Within 4 weeks from the assessment date of visual frailty.
This qualitative data will be remotely collected through a phone call from both the patients with AMD and their relatives/carers
Within 4 weeks from the assessment date of visual frailty.
Expert opinion about visual frailty
Time Frame: From enrolment to the end of the study, an average of approximately 3 months.
This will be collected via an online survey from optometrists and ophthalmologists.
From enrolment to the end of the study, an average of approximately 3 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Edinburgh

Collaborators

NHS Lothian

Investigators

  • Principal Investigator: Peter Cackett, Princess Alexandra Eye Pavilion
  • Study Director: Ian Underwood, School of Engineering, University of Edinburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 9, 2025

Primary Completion (Estimated)

January 11, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

September 10, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC24002
  • REC reference: 24/SS/0021/AM01 (Other Identifier: South East Scotland Research Ethics Committee 01)
  • IRAS project ID: 338463 (Other Identifier: Integrated Research Application System (IRAS))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The anonymised data from the results section will be made available.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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