AMD
Conditions
Keywords
AMD, nAMD
Brief summary
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
Detailed description
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.
Interventions
DIAGNOSTIC_TESTOCT
Optical Coherence Tomography of study eye.
DIAGNOSTIC_TESTVisual Acuity
Visual acuity measured by ETDRS
Sponsors
National Institute for Health Research, United Kingdom
Newcastle University
Cardiff University
City, University of London
King's College London
Manchester University NHS Foundation Trust
University Hospitals Bristol and Weston NHS Foundation Trust
York Teaching Hospitals NHS Foundation Trust
Leeds Teaching Hospital NHS Foundation Trust
Bradford Teaching Hospitals NHS Foundation Trust
University College, London
Moorfields Eye Hospital NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Participants receiving treatment in nAMD injection clinics, who have reached the agreed definition of disease quiescence * Informed consent * Aged \> 55 years * Ability to perform study specific procedures
Exclusion criteria
* Significant media opacities (cataract, vitreous opacities) that would not allow good quality fundus imaging. * Diabetic retinopathy of severity worse than mild non-proliferative stage and with any degree of diabetic maculopathy * History of other causes of Choroidal Neovascularisation (myopic, angioid streaks, inflammatory, retinal dystrophies, secondary to Central Serous Chorioretinopathy, idiopathic).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of Participants who reactivate within 12 months of randomisation but are not identified as having re-activated (false negatives). | 12 months | The proportion of Participants who reactivate within 12 months of randomisation but are not identified as having re-activated (false negatives). |
| 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean change in visual acuity (measured with habitual correction and pinhole) for in the Participants intervention and control groups | 12 months | Mean change in visual acuity (measured with habitual correction and pinhole) for in the Participants intervention and control groups |
| Rate of 'suspicious' lesion classification in community care | 12 months | Rate of 'suspicious' lesion classification in community care |
| Rate of patient non-attendance and loss to follow up in secondary and primary care | 12 months | Rate of patient non-attendance and loss to follow up in secondary and primary care |
| Diagnostic accuracy of the intervention (community optometry follow up of QnAMD) against the reference standard (rate of false negatives and false positives) | 12 months | Diagnostic accuracy of the intervention (community optometry follow up of QnAMD) against the reference standard (rate of false negatives and false positives) |
| Costs of interventions and subsequent care to the NHS modelled over the estimated lifetime | 12 months | Costs of interventions and subsequent care to the NHS modelled over the estimated lifetime |
| Modelled estimates of visual impairment and QALYs based on responses to the EQ-5D-5L. | 12 months | Modelled estimates of visual impairment and QALYs based on responses to the EQ-5D-5L |
| Use of health services and patient costs collected via eCRF and participant completed questionnaires | 12 months | Use of health services and patient costs collected via eCRF and participant completed questionnaires |
| Rate of over-referral (i.e. Reference Standard is quiescent but classification is 'reactivated' or 'suspicious') | 12 months | Rate of over-referral (i.e. Reference Standard is quiescent but classification is 'reactivated' or 'suspicious') |
Countries
United Kingdom
Outcome results
None listed