| NCT ID | NCT06604104 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Edinburgh |
| Condition | Frailty |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2025-04-09 |
| Primary Completion | 2027-01-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2025-04-09 with a primary completion date of 2027-01-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Peter Cackett
PRINCIPAL INVESTIGATOR
Princess Alexandra Eye Pavilion
Frequently Asked Questions
Who can join the NCT06604104 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying Frailty. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06604104 currently recruiting?
Yes, NCT06604104 is actively recruiting participants. Contact the research team at W.Godfrey@sms.ed.ac.uk for enrollment information.
Where is the NCT06604104 trial being conducted?
This trial is being conducted at Edinburgh, United Kingdom, Edinburgh, United Kingdom.
Who is sponsoring the NCT06604104 clinical trial?
NCT06604104 is sponsored by University of Edinburgh. The principal investigator is Peter Cackett at Princess Alexandra Eye Pavilion. The trial plans to enroll 20 participants.