Orthokeratology Plus Traditional Chinese Medicine Fumigation in Children with Unilateral Myopic Anisometropia

This retrospective, nonrandomized cohort study evaluated whether monocular orthokeratology (Ortho-K) combined with Traditional Chinese Medicine (TCM) fumigation was associated with longitudinal ocular outcomes in children with unilateral myopic anisometropia. A total of 101 eligible children were analyzed: 33 in the Ortho-K + Fumigation group, 33 in the Ortho-K group, and 35 in the Spectacle group. The primary outcome was change in axial length (ΔAL) of the initially non-myopic fellow eye. All available post-baseline measurements were analyzed using generalized estimating equations (GEE), with linear mixed-effects and complete-case analyses used to assess robustness to missing follow-up. Fellow-eye ΔAL showed a significant group-by-time interaction (P < 0.001). Compared with Ortho-K alone, the combination group had lower ΔAL at 3, 6, 12, and 18 months (all Bonferroni-adjusted P < 0.001), and both sensitivity analyses supported the primary finding. In the myopic eye, smaller differences between the Ortho-K + Fumigation and Ortho-K groups were significant in the primary GEE at all four visits but were not fully stable in sensitivity analyses. Baseline-adjusted 18-month analyses of secondary dry-eye outcomes showed group differences in tear film break-up time (TBUT), Schirmer I test, and Ocular Surface Disease Index (OSDI), but not corneal fluorescein staining (CFS). Myopia onset did not differ significantly overall, whereas rapid myopic shift showed a modest overall difference; no categorical pairwise comparison remained significant after Bonferroni correction. These results are hypothesis-generating and do not establish causality, prevention, generalized ocular-surface benefit, or long-term safety.