Clinical efficacy of induced epiphora by punctal plugging on refractory dry eye disease with ocular surface Damage: Randomized sham-controlled trial

Abstract

Purpose: To evaluate the efficacy of induced epiphora by punctal plug on refractory dry eye disease (DED) with ocular surface damage. Methods: A 24-week, patient-masked, randomized, sham-controlled trial was conducted. Participants (n = 66) with refractory DED were randomized into treatment and control groups. The treatment group received silicone punctal plugs in both upper and lower eyelids and induced an overflow of tears, while the control group underwent a sham procedure. Efficacy was assessed through changes in Ocular Surface Disease Index (OSDI), SICCA corneal staining score (CSS) over time. Repeated measures ANOVA was performed to test the significance. Results: At baseline, the mean OSDI of the overall participants was 34.1 +/- 11.7, the mean CSS were 1.5 +/- 0.7. The treatment group showed significant improvement in OSDI scores and reduction in CSS compared to the control group, starting as early as 3 weeks and increasing over the study period (all p < 0.05). At the 12- and 24week follow-ups, 70 % achieved mild or lower OSDI scores. Complications of the treatment included plug dislodgement (39.4 %) and skin irritation (33.3 %). Over 90 % of participants reported being satisfied with the induced epiphora. Conclusion: Induced epiphora by punctal plugging showed improvement in both subjective and objective outcomes in patients with refractory DED with ocular surface damage. This approach may serve as a potential adjunctive option for patients unresponsive to standard treatments, warranting careful application and longerterm evaluation.