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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
| Newcastle University | OTHER |
| Cardiff University | OTHER |
| City, University of London |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Arm | Other | All investigations are the same in both arms, but patients within this arm will be seen in the hospital as per standard practice. |
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| Study Arm | Other | All investigations are the same in both arms, but patients within this arm will be seen in a community optometrist practice. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCT | Diagnostic Test | Optical Coherence Tomography of study eye. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The 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). | 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Konstantinos Balaskas | Moorfields Eye Hospital NHS Foundation Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moorfields Eye Hospital NHS Foundation Trust, 162 City Road | Recruiting | London | EC1V 2PD | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42295759 | Derived | Sharma A, Jaber A, Pal B, Lawrenson JG, Harper RA, Tufail A, Learoyd AE, Robinson E, Douiri A, Burman R, Kernohan A, Vougioukalou S, Read S, Csontos J, Jones A, Mahmood S, McKibbin M, Peacock JL, Gale R, Patel PJ, Keane PA, Hamilton R, Vale L, Bunce C, Balaskas K. Community Optometrist-Led Monitoring of Quiescent Neovascular Age-Related Macular Degeneration: The FENETRE Randomized Clinical Trial. JAMA Netw Open. 2026 Jun 1;9(6):e2617984. doi: 10.1001/jamanetworkopen.2026.17984. | |
| 41638748 |
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IPD will not be shared.
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| ID | Term |
|---|---|
| D014792 | Visual Acuity |
| ID | Term |
|---|---|
| D014787 | Vision Tests |
| D003941 | Diagnostic Techniques, Ophthalmological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| OTHER |
| King's College London | OTHER |
| Manchester University NHS Foundation Trust | OTHER_GOV |
| University Hospitals Bristol and Weston NHS Foundation Trust | OTHER |
| York Teaching Hospitals NHS Foundation Trust | OTHER |
| Leeds Teaching Hospital NHS Foundation Trust | UNKNOWN |
| Bradford Teaching Hospitals NHS Foundation Trust | OTHER_GOV |
| University College, London | OTHER |
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| Visual Acuity |
| Diagnostic Test |
Visual acuity measured by ETDRS |
|
| 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') |
| 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 | 12 months |
| Rate of 'suspicious' lesion classification in community care | Rate of 'suspicious' lesion classification in community care | 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 | 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 | 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 | 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 | 12 months |
| Derived |
| Vougioukalou S, Read SM, Csontos JK, Jones A, Jaber A, Sharma A, Balaskas K. Comparing community-based monitoring to hospital-based care of patients with quiescent age-related macular degeneration: a qualitative study of patient and practitioner perspectives on acceptability and access. BMJ Open. 2026 Feb 4;16(2):e101379. doi: 10.1136/bmjopen-2025-101379. |
| 33980536 | Derived | Learoyd AE, Tufail A, Bunce C, Keane PA, Kernohan A, Robinson E, Jaber A, Sadiq S, Harper R, Lawrenson J, Vale L, Waterman H, Douiri A, Balaskas K; FENETRE study group. FENETRE study: quality-assured follow-up of quiescent neovascular age-related macular degeneration by non-medical practitioners: study protocol and statistical analysis plan for a randomised controlled trial. BMJ Open. 2021 May 11;11(5):e049411. doi: 10.1136/bmjopen-2021-049411. |
| D009799 | Ocular Physiological Phenomena |