Purpose: To evaluate long-term retention rates and complications of silicone punctal plugs among dry eye patients.
Design: Prospective, observational cohort study.
Methods: Ninety-five silicone punctal plugs (FCI plugs; FCI Ophthalmics, Issy-les-Moulineaux Cedex, France) were placed in 93 eyes of 47 dry eye patients. Within the observation period of up to eight years, this survey included recording of the retention rate, spontaneous loss, removal, canalicular permeability after loss or removal, as well as other complications such as infection, intrusion, and granuloma.
Results: The retention rate of the plugs was 84.2% after three months, 69.5% after one year, and 55.8% after a median of two years (range, 17 to 93 months). No infection was observed, but granulomatous formation occurred in three eyes (one with extrusion, two with intrusion). Three plugs had to be removed for local discomfort or epiphora, and one piece of a broken plug intruded. Canalicular stenosis after spontaneous loss occurred in 14.3% after three months, in 26.9% after one year, and in 34.2% after a median of two years.
Conclusions: The retention rate after a median of two years of FCI punctal plugs was satisfactory with few complications. The major observation concerned canalicular stenosis after spontaneous loss.