The clinical efficacy of silicone punctal plug therapy.

PURPOSE: To evaluate the clinical efficacy and safety of silicone punctal plugs in various ocular surface disorders. PATIENTS AND METHODS: Medical records of patients who underwent silicone punctal plug insertion from January 1996 to November 2000 were retrospectively reviewed. The clinical data collected included sex and age of the patients, indications for plug insertion, symptoms, corneal fluorescein staining and frequency of lubricant use at baseline and at 4 +/- 2 weeks after the insertion, location (upper versus lower punctum), initial versus replacement plug, spontaneous extrusion or removal of the plug, and percentage of complications and punctum cauterization.
RESULTS: There were 203 eyes of 153 patients (126 women and 27 men) in the study group. The total number of silicone punctal plug procedures was 312. Dry eye syndrome was the most common indication for punctal plug treatment (127 eyes, 62.5%), followed by epitheliopathy after penetrating keratoplasty (32 eyes, 15.8%). The symptoms improved in 150 (73.9%) of 203 eyes at 4 +/- 2 weeks' follow-up. The mean score of the fluorescein staining of the cornea was reduced from 2.7 +/- 0.1 to 1.3 +/- 0.1 with silicone punctal plug treatment at 4 +/- 2 weeks' follow-up. This reduction was statistically significant (p< 0.01). The overall success rate at 4 +/- 2 weeks follow up was 76.8%. The frequency of the lubricant use was significantly decreased with punctal plug treatment (p< 0.001). Considering all plugs, the estimated probability of plug retention was 49.4% with 85.1 +/- 7.3 weeks as the mean survival time. There was no statistical difference in plug retention rates between lower (49.6%) and upper (48.7%) plugs (p= 0.15). Retention rate of first plugs (53.5%) was significantly higher than that of second plugs (32.0%) (p= 0.05). The spontaneous total extrusion of silicone punctal plug was the most common complication in our study (158 plugs, 50.7%). The plug was removed in 14 eyes (14 plugs, 6.9%) because of epiphora in 11 eyes and conjunctival erosion in three eyes. The percentage of punctum cauterization performed in our population was 10.8%.
CONCLUSIONS: Punctal plug insertion is a simple, effective, safe, and reversible method to treat aqueous tear deficiency and other ocular surface diseases, such as epitheliopathy after penetrating keratoplasty, superior limbic keratoconjunctivitis, neurotrophic keratitis, recurrent corneal erosions, and toxic epitheliopathy not controlled by lubrication with preservative-free tears. However, spontaneous extrusion of silicone plug occurs commonly. Careful choosing of the optimal plug size and close follow-up are recommended to ensure the success of the treatment.