Early detection of wet age-related macular degeneration (AMD)
Not Applicable
Completed
- Conditions
- eovascular age-related macular degenerationEye DiseasesNeovascular age-related macular degeneration
- Registration Number
- ISRCTN48855678
- Lead Sponsor
- The Queen's University Belfast (UK)
- Brief Summary
2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34329651/ (added 30/12/2021) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35119357/ (added 07/02/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 552
Inclusion Criteria
1. Newly diagnosed nAMD in one eye and an unaffected second eye
2. Aged 55 years or over
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> 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.<br> 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.<br>
- Secondary Outcome Measures
Name Time Method <br> Secondary diagnostic performance outcomes:<br> 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.<br> 2. Proportion of indeterminate tests: over 3 years of monitoring<br><br> Other outcomes:<br> 1. Time gain of early detection: measured using economic decision analytic model for each candidate test as a diagnostic tool<br> 2. Visual acuity at diagnosis of nAMD (by FFA) within 3 years of follow-up<br> 3. Performance of a risk predictor algorithm according to baseline characteristics<br> 4. Establishment of a well characterised cohort of clinical and biological data for future research<br>