Visual Frailty in Ageing

NCT06604104 | Recruiting

• 3 other identifiers: AC24002REC reference: 24/SS/0021/AM01IRAS project ID: 338463
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Frailty; Age-Related Macular Degeneration; Functional Status; Mental Health; Depression; Anxiety; Cognitive Impairment; Visual Impairment

Keywords

Visual frailty; Frailty; Ageing; Reading performance; Age-related Macular Degeneration (AMD)

Outcome Measures

Primary Outcomes (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.

  Within the first day of enrollment into the study.

Secondary Outcomes (12)

• Visual acuity

  Within the first day of enrollment into the study.

• Reading performance

  Within the first day of enrollment into the study.

• Functional status

  Within the first day of enrollment into the study.

• Mental health (Depression)

  Within the first day of enrollment into the study.

• Mental health (Anxiety)

  Within the first day of enrollment into the study.

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (2)

The Princess Alexandra Eye Pavilion

Edinburgh, Scotland, EH3 9HA, United Kingdom

NOT YET RECRUITING

Anne Rowling Clinic

Edinburgh, United Kingdom

RECRUITING

Related Publications (20)

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  PMID: 18653592 BACKGROUND

• 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.

  PMID: 26382936 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 32056745 BACKGROUND

• 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.

  PMID: 33002726 BACKGROUND

• 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.

  PMID: 33299297 BACKGROUND

• 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.

  PMID: 25603915 BACKGROUND

• 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.

  PMID: 36293591 BACKGROUND

• 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.

  PMID: 14971577 BACKGROUND

• 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.

  PMID: 9596502 BACKGROUND

• 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.

  PMID: 31196384 BACKGROUND

• 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.

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

  PMID: 18929885 BACKGROUND

• 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.

  PMID: 16954455 BACKGROUND

• Loh KY, Ogle J. Age related visual impairment in the elderly. Med J Malaysia. 2004 Oct;59(4):562-8, quiz 569.

  PMID: 15779599 BACKGROUND

• Varadaraj V, Lee MJ, Tian J, Ramulu PY, Bandeen-Roche K, Swenor BK. Near Vision Impairment and Frailty: Evidence of an Association. Am J Ophthalmol. 2019 Dec;208:234-241. doi: 10.1016/j.ajo.2019.08.009. Epub 2019 Aug 26.

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• Partridge L, Deelen J, Slagboom PE. Facing up to the global challenges of ageing. Nature. 2018 Sep;561(7721):45-56. doi: 10.1038/s41586-018-0457-8. Epub 2018 Sep 5.

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  PMID: 10812800 BACKGROUND

Related Links

• Ageing published by The United Nations
• WHO- Blindness and vision impairment
• Eye frailty Awareness by the Japan Ophthalmology Society

MeSH Terms

Conditions

Frailty; Macular Degeneration; Psychological Well-Being; Depression; Anxiety Disorders; Cognitive Dysfunction; Vision Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Retinal Degeneration; Retinal Diseases; Eye Diseases; Personal Satisfaction; Behavior; Behavioral Symptoms; Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms

Study Officials

• Peter Cackett

  Princess Alexandra Eye Pavilion

  PRINCIPAL INVESTIGATOR

• Ian Underwood

  School of Engineering, University of Edinburgh

  STUDY DIRECTOR

Central Study Contacts

Godfrey Wanok, BSc (Hons) Optom; MSc PCO

CONTACT

+447442374789; W.Godfrey@sms.ed.ac.uk

Baljean Dhillon

CONTACT

Baljean.Dhillon@ed.ac.uk

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 19, 2024
• Study Start: April 9, 2025
• Primary Completion (Estimated): January 11, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

GB (2)