Ignite Creation Date:
2025-12-24 @ 7:50 PM
Ignite Modification Date:
2025-12-29 @ 5:35 PM
Study NCT ID:
NCT06604104
Status:
RECRUITING
Last Update Posted:
2025-09-30
First Post:
2024-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visual Frailty in Ageing
Sponsor:
University of Edinburgh
Organization:
Study Overview
Official Title:
Seeing Through Their Eyes - Towards Defining Visual Frailty in Ageing
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VFiA
Brief Summary:
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.
* 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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: