Recipient organisationQueen's University BelfastSource-published name: The Queen's University of Belfast
Funding£2.2M
PeriodJan 2015 — Mar 2020
In plain English
AI plain-English summary
A patient with a new diagnosis of wet macular degeneration in one eye will be tested with five different routine NHS eye exams every time they visit the clinic, to see which test—or combination of tests—catches the disease earliest in their still-healthy second eye. This matters because wet macular degeneration can destroy central vision within weeks if untreated. Catching it in the second eye early enough to start injections before symptoms appear could save sight, but no one knows which of the standard monitoring tests is best at detecting the earliest signs. The current approach—using all tests at every visit—is costly and may not be optimal. If this research succeeds, it will produce an evidence-based monitoring strategy that tells clinicians exactly which tests to use and how often, based on cost per quality-adjusted life year gained. This could change how thousands of NHS patients are monitored each year, preventing unnecessary vision loss while reducing clinic burden. The study will also build a risk calculator from patient characteristics and a well-characterised cohort for future research.
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Design: Multi-centre prospective cohort diagnostic accuracy study with 3 year follow-up Setting: Secondary care, ophthalmology outpatient departments Target population: Patients with newly diagnosed neovascular age related macular degeneration (nAMD) in one eye and an unaffected second eye (study eye) Inclusion criteria: Newly diagnosed (within last 3 months) with nAMD in one eye and an unaffected second eye confirmed by fundus fluorescein angiogram (FFA); about to commence or recently commenced anti VEGF therapy in the first eye; age 50-95. Exclusion criteria: patients with a history of nAMD in both eyes; nAMD detected in the study eye at baseline screening visit; presenting visual acuity worse than 73 letters in the study eye and/or retinal pathology which can confound subsequent assessments (eg. diabetic retinopathy, macular hole); not undergoing regular monitoring in standard of care; patients who cannot give informed consent; unable to undergo a FFA test Health technologies being assessed: The diagnostic technologies (tests) to be assessed are: (1) an evaluation of the fundus (a view of the retina through the dilated pupil using biomicroscopy or photography); (2) subjective change in vision in the unaffected eye, determined by questioning the patient; (3) visual acuity – measured using a sight chart; (4) Amsler test - a simple subjective test consisting of straight lines on a piece of paper that may appear distorted in patients with retinal disease; (5) optical coherence tomography (OCT) - an imaging technique providing high resolution, cross-sectional, imaging of the retina. All of the five comparator tests are routinely used in NHS outpatient clinics. Patients will be tested using all these technologies on their study eye at each treatment and/or monitoring visit for the affected eye. A positive test on one or more technologies will trigger an additional reference standard test (FFA) to confirm or rule out the presence of nAMD. The FFA scan involves injecting a dye into the circulation and taking photos of the back of the eye to look for signs of damage. In addition, FFA will be carried out in all patients in the study at baseline, 18 and 36 months. Primary outcome: The primary diagnostic performance outcomes will be the sensitivity and specificity of comparator tests on detection of nAMD in the study eye in a monitoring setting. The primary economic outcome will be the incremental costs (to the health service) per quality adjusted life year (QALY) gained. Secondary outcomes: Secondary diagnostic performance outcomes will include diagnostic odds ratio, likelihood ratio, proportion of indeterminate tests. The performance of combinations of tests will be evaluated. Other outcomes: time gain of early detection; visual acuity at diagnosis, the development of a risk calculator based upon baseline characteristics, establishment of a well-characterised cohort of clinical data for future research and biobank. Developing an optimal monitoring regime: A decision analytic model will be developed to determine the optimal monitoring strategy for patients with nAMD in one eye, in terms of clinical and cost effectiveness. Alternative monitoring strategies will be superimposed on top of a natural history model of disease progression, and risk of developing nAMD, using the sensitivity/specificity estimates obtained for alternative tests used within alternative monitoring strategies (obtained from analysis of the prospective cohort). To inform model parameters we will use a combination of primary analysis of the observed cohort as well as further data available from the literature. The analysis will capture cumulative health and social care costs, visual acuity outcomes, and quality adjusted life years. Data collection: The standard of care in the NHS for patients with nAMD is regular assessment and treatment (which is monthly for the first 3 months after diagnosis and then bimonthly during year 1. Review i
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