Neovascular age-related macular degeneration Eye Diseases Neovascular age-related macular degeneration
Conditions
Interventions
Planned Interventions
Patients will attend regular monitoring visits for the fellow eye (with nAMD). The frequency of visits will be approximately every 8 weeks, as per local practice.
Sponsors
The Queen's University Belfast (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Newly diagnosed nAMD in one eye and an unaffected second eye 2. Aged 55 years or over
Exclusion criteria
Exclusion criteria: 1. Age less than 55 years old 2. Patients who cannot give informed consent 3. Patients with a history of nAMD in both eyes 4. Unable to undergo a fundus fluorescein angiography (FFA) test 5. Not undergoing regular monitoring in standard of care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The primary diagnostic outcome measures are the sensitivity and specificity of each of the five candidate tests (fundus examination, patient?s subjective assessment of vision, visual acuity, Amsler test, OCT) on any diagnosis of nAMD confirmed by FFA in the study eye over 3 years of monitoring. 2. The primary economic outcome measure will be the incremental cost to the health service per quality-adjusted life-year (QALY) gained for each candidate test used as a diagnostic tool. We will use the complete cohort data at 3 years follow-up to estimate total monitoring and treatment costs to 3 years, and to model the longer-term cost effectiveness of the alternative monitoring strategies through their impact on the timing of treatment initiation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary diagnostic performance outcomes: 1. Diagnostic odds ratio, likelihood ratio, diagnostic performance (sensitivity and specificity) of combinations of tests: measured from candidate test results compared to reference standard (FFA) over 3 years. 2. Proportion of indeterminate tests: over 3 years of monitoring Other outcomes: 1. Time gain of early detection: measured using economic decision analytic model for each candidate test as a diagnostic tool 2. Visual acuity at diagnosis of nAMD (by FFA) within 3 years of follow-up 3. Performance of a risk predictor algorithm according to baseline characteristics 4. Establishment of a well characterised cohort of clinical and biological data for future research | — |
Countries
Northern Ireland, United Kingdom
Outcome results
None listed