To assess the reliability and the diagnostic performance of a novel CE (European Conformity)-marked and FDA (Food and Drug Administration)-cleared dot patient self-monitoring test (Alleye, Oculocare medical Inc.) for the detection and characterization of metamorphopsia in age-related macular degeneration (AMD).
Three consecutive tests were performed in 63 wet AMD, 26 dry AMD, and 19 age-matched healthy eyes. In addition, the test was performed in 34 young healthy eyes. The mean Alleye score and standard deviations (SDs) were calculated for each eye and group. We compared and tested healthy with dry and wet AMD eyes and assessed the extent to which the test discriminated between healthy subjects and patients with dry and wet AMD using the area under the receiver operating characteristic curve (AUC).
The mean (SD) Alleye score was 49.5 (16.1) in wet AMD eyes, 62.1 (22.5) in dry AMD eyes, 69.8 (10.2) in age-matched healthy eyes, and 85.3 (10.0) in young healthy subjects. Compared to age-matched healthy subjects, the AUC (95% confidence interval) to detect wet AMD was 0.845 (0.759-0.932), and 0.660 (0.520-0.799) to discriminate between dry and wet AMD. Compared to young healthy subjects, the AUC to detect dry AMD was 0.799 (0.675-0.923), and 0.969 (0.940-0.997) to detect wet AMD.
This is the first assessment of Alleye in clinical practice. The test is highly accurate to detect wet AMD and reasonably accurate to classify dry vs. wet AMD. Data from longitudinal monitoring and its role in the therapeutic management of AMD is warranted.