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FrailtyVFiANCT06604104

Visual Frailty in Ageing

An observational study of Frailty and Age-Related Macular Degeneration, run by University of Edinburgh at 2 sites in United Kingdom.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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)… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
How many people
20 participants
Where
2 sitesUnited Kingdom
Study dates
9 Apr 2025to Feb 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Godfrey Wanok, BSc (Hons) Optom; MSc PCO contact

+447442374789

W.Godfrey@sms.ed.ac.uk

Baljean Dhillon contact

Baljean.Dhillon@ed.ac.uk

United Kingdom2 sites, 2 recruiting

  • The Princess Alexandra Eye Pavilion

    Edinburgh, Scotland, EH3 9HA

    Andy Mackay, +441506522163, andrew.mackay5@nhslothian.scot.nhs.uk

    Peter Cackett, peter.cackett@nhs.scot

    Not yet recruiting

  • Anne Rowling Clinic

    Edinburgh

    Dawn Lyle, dawn.lyle@ed.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

Official title: 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?
Read more

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.

Read the 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.

Keywords
Visual frailty, Frailty, Ageing, Reading performance, Age-related Macular Degeneration (AMD)
Medical subject headings
Frailty, Macular Degeneration, Psychological Well-Being, Depression, Anxiety Disorders, Cognitive Dysfunction, Vision Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Within the first day of enrollment into the study.

Secondary outcomes (12)

  1. Visual acuity

    Visual acuity will be assessed using logMAR charts and will be recorded in logMAR units.

    Measured: Within the first day of enrollment into the study.

  2. 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)

    Measured: Within the first day of enrollment into the study.

  3. 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.

    Measured: Within the first day of enrollment into the study.

  4. 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

    Measured: Within the first day of enrollment into the study.

  5. 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

    Measured: Within the first day of enrollment into the study.

  6. 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.

    Measured: Within the first day of enrollment into the study.

  7. Co-morbidities

    These will be collected from the medical records of participants and a simple count of the conditions will be used.

    Measured: Within the first day of enrollment into the study.

  8. 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.

    Measured: Within the first day of enrollment into the study.

  9. Correlation between visual frailty and physical frailty

    Results of visual frailty and physical frailty will be analysed to establish the correlation between the two.

    Measured: This will be done immediately after assessment of both visual frailty and physical on the first day.

  10. 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.

    Measured: This will be done immediately after assessment of physical frailty on the first day.

  11. 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

    Measured: Within 4 weeks from the assessment date of visual frailty.

  12. Expert opinion about visual frailty

    This will be collected via an online survey from optometrists and ophthalmologists.

    Measured: From enrolment to the end of the study, an average of approximately 3 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2024
  2. Study start9 Apr 2025
  3. Primary completion11 Jan 2027 (estimated)
  4. Study completionFeb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06604104
Sponsor's protocol ID
AC24002
Other IDs
REC reference: 24/SS/0021/AM01, IRAS project ID: 338463
Acronym
VFiA
Status last verified
Mar 2026
First submitted
10 Sep 2024
Last updated
4 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The anonymised data from the results section will be made available.

Publications

  • Rahi JS, Cumberland PM, Peckham CS. Visual impairment and vision-related quality of life in working-age adults: findings in the 1958 British birth cohort. Ophthalmology. 2009 Feb;116(2):270-4. doi: 10.1016/j.ophtha.2008.09.018. Epub 2008 Dec 16.

    PubMed 19091416

  • Polack S, Kuper H, Wadud Z, Fletcher A, Foster A. Quality of life and visual impairment from cataract in Satkhira district, Bangladesh. Br J Ophthalmol. 2008 Aug;92(8):1026-30. doi: 10.1136/bjo.2007.134791.

    PubMed 18653592

  • Peters D, Heijl A, Brenner L, Bengtsson B. Visual impairment and vision-related quality of life in the Early Manifest Glaucoma Trial after 20 years of follow-up. Acta Ophthalmol. 2015 Dec;93(8):745-52. doi: 10.1111/aos.12839. Epub 2015 Sep 18.

    PubMed 26382936

  • Dzenana RA, Smaila H. Quality of life of elderly people with visual impairment in relation to the degree of visual impairment. Human Research in Rehabilitation. 2022, DOI: 10.21554/hrr.042207

  • Rahman MS, Rahman MA, Ali M, Rahman MS, Maniruzzaman M, Yeasmin MA, Ahmed NAMF, Abedin MM, Islam SMS. Determinants of depressive symptoms among older people in Bangladesh. J Affect Disord. 2020 Mar 1;264:157-162. doi: 10.1016/j.jad.2019.12.025. Epub 2019 Dec 16.

    PubMed 32056745

  • Dong X, Ng N. Contribution of multiple pathways to the relationship between visual impairment and depression: Explaining mental health inequalities among older Chinese adults. J Affect Disord. 2021 Jan 1;278:350-356. doi: 10.1016/j.jad.2020.09.068. Epub 2020 Sep 14.

    PubMed 33002726

  • Demmin DL, Silverstein SM. Visual Impairment and Mental Health: Unmet Needs and Treatment Options. Clin Ophthalmol. 2020 Dec 3;14:4229-4251. doi: 10.2147/OPTH.S258783. eCollection 2020.

    PubMed 33299297

  • Court H, McLean G, Guthrie B, Mercer SW, Smith DJ. Visual impairment is associated with physical and mental comorbidities in older adults: a cross-sectional study. BMC Med. 2014 Oct 17;12:181. doi: 10.1186/s12916-014-0181-7.

    PubMed 25603915

  • Itokazu M, Ishizaka M, Uchikawa Y, Takahashi Y, Niida T, Hirose T, Ito A, Yakabi A, Endo Y, Sawaya Y, Igawa T, Kobayashi K, Hara T, Watanabe M, Kubo A, Urano T. Relationship between Eye Frailty and Physical, Social, and Psychological/Cognitive Weaknesses among Community-Dwelling Older Adults in Japan. Int J Environ Res Public Health. 2022 Oct 11;19(20):13011. doi: 10.3390/ijerph192013011.

    PubMed 36293591

  • Klein BE, Klein R, Knudtson MD, Lee KE. Relationship of measures of frailty to visual function: the Beaver Dam Eye Study. Trans Am Ophthalmol Soc. 2003;101:191-6; discussion 196-9.

    PubMed 14971577

  • Klaver CC, Wolfs RC, Vingerling JR, Hofman A, de Jong PT. Age-specific prevalence and causes of blindness and visual impairment in an older population: the Rotterdam Study. Arch Ophthalmol. 1998 May;116(5):653-8. doi: 10.1001/archopht.116.5.653.

    PubMed 9596502

  • Wolfram C, Schuster AK, Elflein HM, Nickels S, Schulz A, Wild PS, Beutel ME, Blettner M, Munzel T, Lackner KJ, Pfeiffer N. The Prevalence of Visual Impairment in the Adult Population. Dtsch Arztebl Int. 2019 Apr 26;116(17):289-295. doi: 10.3238/arztebl.2019.0289.

    PubMed 31196384

  • Prince MJ, Wu F, Guo Y, Gutierrez Robledo LM, O'Donnell M, Sullivan R, Yusuf S. The burden of disease in older people and implications for health policy and practice. Lancet. 2015 Feb 7;385(9967):549-62. doi: 10.1016/S0140-6736(14)61347-7. Epub 2014 Nov 6.

    PubMed 25468153

  • Blindness in the elderly. Lancet. 2008 Oct 11;372(9646):1273. doi: 10.1016/S0140-6736(08)61527-5. No abstract available.

    PubMed 18929885

  • Salvi SM, Akhtar S, Currie Z. Ageing changes in the eye. Postgrad Med J. 2006 Sep;82(971):581-7. doi: 10.1136/pgmj.2005.040857.

    PubMed 16954455

Questions about this trial

What is this clinical trial studying?

An observational study of Frailty and Age-Related Macular Degeneration, run by University of Edinburgh at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Godfrey Wanok, BSc (Hons) Optom; MSc PCO (+447442374789, W.Godfrey@sms.ed.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual frailty (time frame: Within the first day of enrollment into the study.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06604104, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.

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