Tear-Film Stability and Ocular Symptoms During Two Years of Low-Dose Atropine Treatment in Children: A Secondary Analysis of the ASPECT Trial

Background/Objectives: Long-term tear-film and symptom data for compounded 0.025% atropine remain limited in European children. We assessed changes in first non-invasive tear-film break-up time (fNIBUT) and Ocular Surface Disease Index (OSDI) scores over 24 months.

Methods

This secondary analysis of the ASPECT trial included 101 children completing 24 months, all assigned nightly compounded 0.025% atropine with Defocus Incorporated Multiple Segments or single-vision spectacles. Available fNIBUT, OSDI, and corneal endothelial cell density (ECD) measurements at baseline, 12 months, and 24 months were analysed using longitudinal mixed-effects models. The six pairwise contrasts across the primary outcomes of this secondary analysis used Holm-adjusted p-values and simultaneous Bonferroni 95% confidence intervals (CIs). No untreated comparator was available.