Abstract
PurposeTo evaluate the diagnostic accuracy of routinely used tests of visual function and retinal morphology compared with fundus fluorescein angiography (FFA) to detect onset of active macular neovascularization in unaffected fellow eyes of patients with unilateral neovascular age-related macular degeneration (nAMD).DesignProspective diagnostic accuracy cohort study conducted in 24 eye clinics in the United Kingdom over 3 years.ParticipantsOlder adults (>50 years) with recently diagnosed unilateral nAMD with a fellow (study) eye free of nAMD.MethodsSelf-reported vision, Amsler, clinic-measured visual acuity (VA), fundus assessment, and spectral domain OCT. The reference standard is FFA.Main Outcome MeasuresSensitivity and specificity of the 5 index tests.ResultsOf 552 participants monitored for up to 3 years, 145 (26.3%) developed active nAMD in the study eye, of whom 120 had an FFA at detection and constituted the primary analysis cohort. Index test positives at nAMD detection in those confirmed by FFA were self-reported vision much worse (5), distortion on Amsler (33), 10-letter decrease in acuity from baseline (36), fundus examination (64), and OCT (110). Percentage index test sensitivities were: self-reported vision 4.2 (95% confidence interval [CI], 1.6–9.8); Amsler 33.7 (95% CI, 25.1–43.5); VA 30.0 (95% CI, 22.5–38.7); fundus examination 53.8 (95% CI, 44.8–62.5); and OCT 91.7 (95% CI, 85.2–95.6). All 5 index test specificities were high at 97.0 (95% CI, 94.6–98.5), 81.4 (95% CI, 76.4–85.5), 66.3 (95% CI, 61.0–71.1), 97.6 (95% CI, 95.3–98.9), and 87.8 (95% CI, 83.8–90.9), respectively. The combination of OCT with one other index test that was a secondary outcome measure increased sensitivity marginally and decreased specificity for all combinations except fundus examination.ConclusionsTests of self-reported change in vision, unmasking of new distortion, measurements of acuity, and fundus checks to diagnose active nAMD performed poorly in contrast to OCT. Our findings support a change to guidelines in clinical practice to monitor for onset of nAMD.
Highlights
To evaluate the diagnostic accuracy of routinely used tests of visual function and retinal morphology compared with fundus fluorescein angiography (FFA) to detect onset of active macular neovascularization in unaffected fellow eyes of patients with unilateral neovascular age-related macular degeneration
Routine clinical care data obtained from electronic medical records of patients with bilateral neovascular age-related macular degeneration (nAMD) treated with anti-vascular endothelial growth factor (VEGF) shows that second eyes with generally good visual acuity (VA) at diagnosis maintain better function over 3 years compared with first eyes that commenced treatment with on average lower levels of VA.[4]
Detection of nAMD at onset is made by fundus fluorescein angiography (FFA), which is the confirmatory diagnostic test according to the Age-Related Macular Degeneration Practice Patterns of the American Academy of Ophthalmology.[5]
Summary
The Early Detection of Neovascular Age-Related Macular Degeneration (EDNA) study was a 3-year multicenter, prospective, cohort, comparative diagnostic accuracy study conducted in a monitoring setting in 24 ophthalmology departments within UK NHS hospitals. In the absence of a trigger arising from a positive index test, 2 additional planned study visits were undertaken at month 18 and on completion of the study (study exit) At these visits, protocolbased study procedures for the measurement of all index tests, self-reported vision, Amsler, VA retinal imaging (color photography, SD-OCT), and fluorescein angiography were performed (Fig S1, available at www.aaojournal.org). Self-reported vision: A positive test was defined as a worsening reported by the participant for subjective assessment of vision in the EDNA study eye This was assessed using the following question: “How is your vision in the (unaffected) eye compared to the last visit?” with the following 4 possible answers: “about the same or better,” “a bit worse,” “worse,” or “much worse.”. Visual acuity tested on ETDRS vision charts: A positive test was defined as a reduction of 10 or more letters in VA from the baseline measurement
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