{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,1]],"date-time":"2026-07-01T00:29:21Z","timestamp":1782865761686,"version":"3.54.5"},"reference-count":128,"publisher":"National Institute for Health and Care Research","issue":"8","license":[{"start":{"date-parts":[[2022,1,1]],"date-time":"2022-01-01T00:00:00Z","timestamp":1640995200000},"content-version":"unspecified","delay-in-days":0,"URL":"http:\/\/www.nationalarchives.gov.uk\/doc\/non-commercial-government-licence\/non-commercial-government-licence.htm"}],"funder":[{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment programme","doi-asserted-by":"publisher","award":["12\/142\/07"],"award-info":[{"award-number":["12\/142\/07"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["journalslibrary.nihr.ac.uk"],"crossmark-restriction":false},"short-container-title":["Health Technol Assess"],"abstract":"\n Background<\/jats:title>\n Neovascular age-related macular degeneration is a leading cause of sight loss, and early detection and treatment is important. For patients with neovascular age-related macular degeneration in one eye, it is usual practice to monitor the unaffected eye. The test used to diagnose neovascular age-related macular degeneration, fundus fluorescein angiography, is an invasive test. Non-invasive tests are available, but their diagnostic accuracy is unclear.<\/jats:p>\n <\/jats:sec>\n \n Objectives<\/jats:title>\n The primary objective was to determine the diagnostic monitoring performance of tests for neovascular age-related macular degeneration in the second eye of patients with unilateral neovascular age-related macular degeneration. The secondary objectives were the cost-effectiveness of tests and to identify predictive factors of developing neovascular age-related macular degeneration.<\/jats:p>\n <\/jats:sec>\n \n Design<\/jats:title>\n This was a multicentre, prospective, cohort, comparative diagnostic accuracy study in a monitoring setting for up to 3 years. A Cox regression risk prediction model and a Markov microsimulation model comparing cost-effectiveness of the index tests over 25 years were used.<\/jats:p>\n <\/jats:sec>\n \n Setting<\/jats:title>\n This took place in hospital eye services.<\/jats:p>\n <\/jats:sec>\n \n Participants<\/jats:title>\n Participants were adults (aged 50\u201395 years) with newly diagnosed (within the previous 6 weeks) neovascular age-related macular degeneration in one eye and an unaffected second (study) eye who were attending for treatment injections in the first eye and who had a study eye baseline visual acuity of \u2265\u200968 Early Treatment Diabetic Retinopathy Study letters.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n The index tests were Amsler chart (completed by participants), fundus clinical examination, optical coherence tomography, self-reported vision assessment (completed by participants) and visual acuity. The reference standard was fundus fluorescein angiography.<\/jats:p>\n <\/jats:sec>\n \n Main outcome measures<\/jats:title>\n The main outcome measures were sensitivity and specificity; the performance of the risk predictor model; and costs and quality-adjusted life-years.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n In total, 552 out of 578 patients who consented from 24 NHS hospitals (n<\/jats:italic>\u2009=\u200916 ineligible; n<\/jats:italic>\u2009=\u200910 withdrew consent) took part. The mean age of the patients was 77.4 years (standard deviation 7.7 years) and 57.2% were female. For the primary analysis, 464 patients underwent follow-up fundus fluorescein angiography and 120 developed neovascular age-related macular degeneration on fundus fluorescein angiography. The diagnostic accuracy [sensitivity (%) (95% confidence interval); specificity (%) (95% confidence interval)] was as follows: optical coherence tomography 91.7 (85.2 to 95.6); 87.8 (83.8 to 90.9)], fundus clinical examination [53.8 (44.8 to 62.5); 97.6 (95.3 to 98.9)], Amsler [33.7 (25.1 to 43.5); 81.4 (76.4 to 85.5)], visual acuity [30.0 (22.5 to 38.7); 66.3 (61.0 to 71.1)] and self-reported vision [4.2 (1.6 to 9.8); 97.0 (94.6 to 98.5)]. Optical coherence tomography had the highest sensitivity across all secondary analyses. The final prediction model for neovascular age-related macular degeneration in the non-affected eye included smoking status, family history of neovascular age-related macular degeneration, the presence of nodular drusen with or without reticular pseudodrusen, and the presence of pigmentary abnormalities [c<\/jats:italic>-statistic 0.66 (95% confidence interval 0.62 to 0.71)]. Optical coherence tomography monitoring generated the greatest quality-adjusted life-years gained per patient (optical coherence tomography, 5.830; fundus clinical examination, 5.787; Amsler chart, 5.736, self-reported vision, 5.630; and visual acuity, 5.600) for the lowest health-care and social care costs (optical coherence tomography, \u00a319,406; fundus clinical examination, \u00a319,649; Amsler chart, \u00a319,751; self-reported vision, \u00a320,198; and visual acuity, \u00a320,444) over the lifetime of the simulated cohort. Optical coherence tomography dominated the other tests or had an incremental cost-effectiveness ratio below the accepted cost-effectiveness thresholds (\u00a320,000) across the scenarios explored.<\/jats:p>\n <\/jats:sec>\n \n Limitations<\/jats:title>\n The diagnostic performance may be different in an unselected population without any history of neovascular age-related macular degeneration; the prediction model did not include genetic profile data, which might have improved the discriminatory performance.<\/jats:p>\n <\/jats:sec>\n \n Conclusions<\/jats:title>\n Optical coherence tomography was the most accurate in diagnosing conversion to neovascular age-related macular degeneration in the fellow eye of patients with unilateral neovascular age-related macular degeneration. Economic modelling suggests that optical coherence tomography monitoring is cost-effective and leads to earlier diagnosis of and treatment for neovascular age-related macular degeneration in the second eye of patients being treated for neovascular age-related macular degeneration in their first eye.<\/jats:p>\n <\/jats:sec>\n \n Future work<\/jats:title>\n Future works should investigate the role of home monitoring, improved risk prediction models and impact on long-term visual outcomes.<\/jats:p>\n <\/jats:sec>\n \n Study registration<\/jats:title>\n This study was registered as ISRCTN48855678.<\/jats:p>\n <\/jats:sec>\n \n Funding<\/jats:title>\n This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment<\/jats:italic>; Vol. 26, No. 8. See the NIHR Journals Library website for further project information.<\/jats:p>\n <\/jats:sec>","DOI":"10.3310\/vlfl1739","type":"journal-article","created":{"date-parts":[[2022,2,4]],"date-time":"2022-02-04T14:26:40Z","timestamp":1643984800000},"page":"1-142","update-policy":"https:\/\/doi.org\/10.3310\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":15,"title":["Non-invasive testing for early detection of neovascular macular degeneration in unaffected second eyes of older adults: EDNA diagnostic accuracy study"],"prefix":"10.3310","volume":"26","clinical-trial-number":[{"clinical-trial-number":"isrctn48855678","registry":"10.18810\/isrctn","type":"results"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-2189-3755","authenticated-orcid":true,"given":"Katie","family":"Banister","sequence":"first","affiliation":[{"name":"Health Services Research Unit, University of Aberdeen, Aberdeen, 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