Randomized, sham-controlled trial of acupuncture for post-cataract surgery dry eye disease

Purpose: To determine the efficacy of acupuncture in patients with post-cataract surgery dry eye disease (DED).Methods: Ninety participants with post-cataract surgery DED were randomly assigned (1:1) to receive true acupuncture (n = 44) or non-penetrating sham acupuncture (n = 46) twice weekly for 8 weeks. The primary outcome was the change from baseline to week 8 in the noninvasive tear film break-up time (TFBUT). Partici-pants were followed until week 12. Secondary outcomes included Ocular Surface Disease Index (OSDI) score, tear meniscus height (TMH), corneal fluorescein staining (CFS) score, meiboscore and corrected distance visual acuity (CDVA).Results: The estimated mean change from baseline in the noninvasive TFBUT was 1.52 for true acupuncture versus 0.77 for sham acupuncture (adjusted difference-0.75 [95% CI-1.39 to-0.12]; P = 0.02) at week 8 and 1.49 for true acupuncture versus 0.81 for sham acupuncture (adjusted difference-0.68 [95% CI,-1.29 to -0.07]; P = 0.029) at week 12. The mean change in the OSDI score was-20.13 for true acupuncture versus -13.44 for sham acupuncture (adjusted difference 6.69 [95% CI, 0.64 to 12.74]; P = 0.031) at week 8, but revealed no statistically between-group differences at week 12. Mean changes in TMH, CFS score, meiboscore and CDVA did not differ significantly between the two groups.Conclusions: Among patients with post-cataract surgery DED, acupuncture compared with sham acupuncture resulted in statistically significant benefit on tear film stability. Trial registration: Chinese Clinical Trial Registry (ChiCTR1800020132)