Clinical Investigation of the Extrusion Rate and Other Complications of the New Super Flex Plug~R Punctal Plug and Other Plugs

摘要

Purpose: Currently, there are only three punctum plugs available for use in Japan [EaglePlug~R (EP), Eagle Flex Plug~R (FP), and Punctal Plug~R (PP)].This study investigated the effectiveness of the newly marketed Super Flex Plug~R (SFP).Subjects and Methods: This study involved 291 eyes of 224 severe dry eye patients treated at the dry eye clinic of Kyoto Prefectural University of Medicine, Kyoto, Japan. For the SFP, EP, FP, and PP, this study compared the extrusion rate of each plug and other complications, including enlargement of the size of the punctum after extrusion, granulation, and the accumulation of soft whitish material around the plugs.Results: During the evaluation periods, the elapsed times until extrusion were significantly longer for SFP than for EP and FP (p < 0.001). In all cases, there was a significant enlargement of the size of the punctum (mm) after extrusion of the SFP [0.74 +- 0.13 (mean +- SD)] as compared to that before insertion [0.62 + 0.14 (p < 0.0001)]. Granulation formedin 1.7% of the SFP cases, but the frequency was lower than that in PP cases (19%). No soft whitish material around the plug was seen in SFP-inserted eyes. Conclusion: The SFP was harder to extrude, and was found to cause granulation. After extrusion of the SFP, the punctum was likely to be enlarged.