This is a prospective, randomised, multi-site clinical trial testing the non-inferiority of community optometry follow-up of participants with QnAMD over 12 months
Neovascular Age-Related Macular Degeneration (nAMD) is a common vision threatening condition affecting mainly patients over the age of 65. At some point during follow-up the disease becomes inactive in many cases and does not need more injections. The risk of a flare-up is high, however, and patients need to continue to be seen every month for a significant period of time. Hospital-based eye clinics are struggling to cope with current and expected workload for assessing and treating patients with nAMD. Transferring care of these patients to the community closer to home would ease the workload for hospital based clinics and offer a better experience of care to patients. This study will recruit 742 patients with nAMD who have reached this inactive phase of the disease. Half of the patients that want to take part will continue to have their follow-up appointments in the hospital eye clinics as usual. The other half, chosen by chance, will have follow-up visits every month in a community optometrist practice by trained optometrists. The research team will provide the training for community optometrists. The study will seek to show that the community based care is no less safe than hospital-based care. The study will also check what is the impact of this different way of offering care on the NHS budget and how the patients and practitioners perceive this. The study will involve several hospital eye clinics across the country and several community optometrist practices. Meetings will also be held with patients to discuss their priorities and needs when looking at how to set up the community based eye clinics. During meetings with patients in preparation for this research, they felt positively about the possibility to receive care closer to home.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
742
Optical Coherence Tomography of study eye.
Visual acuity measured by ETDRS
Moorfields Eye Hospital NHS Foundation Trust, 162 City Road
London, United Kingdom
RECRUITINGThe proportion of Participants who reactivate within 12 months of randomisation but are not identified as having re-activated (false negatives).
The proportion of Participants who reactivate within 12 months of randomisation but are not identified as having re-activated (false negatives).
Time frame: 12 months
Primary economic outcome: Incremental cost per quality adjusted life year (QALY) gained over the estimated patient lifetime estimated from an economic model informed by trial data.
Primary economic outcome: Incremental cost per quality adjusted life year (QALY) gained over the estimated patient lifetime estimated from an economic model informed by trial data.
Time frame: 12 months
Diagnostic accuracy of the intervention (community optometry follow up of QnAMD) against the reference standard (rate of false negatives and false positives)
Diagnostic accuracy of the intervention (community optometry follow up of QnAMD) against the reference standard (rate of false negatives and false positives)
Time frame: 12 months
Rate of over-referral (i.e. Reference Standard is quiescent but classification is 'reactivated' or 'suspicious')
Rate of over-referral (i.e. Reference Standard is quiescent but classification is 'reactivated' or 'suspicious')
Time frame: 12 months
Mean change in visual acuity (measured with habitual correction and pinhole) for in the Participants intervention and control groups
Mean change in visual acuity (measured with habitual correction and pinhole) for in the Participants intervention and control groups
Time frame: 12 months
Rate of 'suspicious' lesion classification in community care
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Rate of 'suspicious' lesion classification in community care
Time frame: 12 months
Rate of patient non-attendance and loss to follow up in secondary and primary care
Rate of patient non-attendance and loss to follow up in secondary and primary care
Time frame: 12 months
Use of health services and patient costs collected via eCRF and participant completed questionnaires
Use of health services and patient costs collected via eCRF and participant completed questionnaires
Time frame: 12 months
Costs of interventions and subsequent care to the NHS modelled over the estimated lifetime
Costs of interventions and subsequent care to the NHS modelled over the estimated lifetime
Time frame: 12 months
Modelled estimates of visual impairment and QALYs based on responses to the EQ-5D-5L.
Modelled estimates of visual impairment and QALYs based on responses to the EQ-5D-5L
Time frame: 12 months