Randomized Controlled Trial of Intradermal Pressing Needle Plus Artificial Tears for Perimenopausal Dry Eye

Abstract

This exploratory, randomized, single-blind controlled trial aimed to observe the clinical effect of pressing needle combined with artificial tears versus artificial tears alone in the treatment of perimenopausal women with dry eyes. A total of 40 perimenopausal women with dry eyes were randomly divided into a control group (20 patients) and an observation group (20 patients). The control group was treated with artificial tears while the observation group was treated with pressing needle and embedding needle in addition to artificial tears. The primary outcome was the change in tear film break-up time (BUT) from baseline to 2 weeks. Secondary outcomes included the Schirmer I test (SIT), corneal fluorescein staining (CFS) score, subjective symptom score, and clinical response rate. After 2 weeks, the observation group showed significantly greater improvement in BUT (between-group mean difference 0.715 s; 95% CI: 0.358–1.072 s, P < 0.001) and SIT (between-group mean difference 0.697 mm; 95% CI: 0.310–1.084 mm, P < 0.001) compared with the control group. No statistically significant between-group differences were found in subjective symptom scores (P = 0.440) or CFS scores (P = 0.069). The total clinical effective rate was significantly higher in the observation group (95.00%) than that in the control group (65.00%, P = 0.044). No treatment-related adverse events were reported. Pressing needle used in clinical application effectively improved the dry eye symptoms of perimenopausal women, promoted the secretion of tears, and prolonged the tear film rupture time.