A study about smart plugs that makes no reference whatsoever to the very serious complications that have presented a clear trend over their ten years on the market. Great, just great.
What this study DOES say however is that in terms of clinical efficacy (without reference to safety) SmartPlugs and ordinary punctal plugs were not noticeably different... rather sounds like the authors are defending SmartPlugs, but really, if they do not outperform other plugs, it just eliminates even more potential rationale for using them at all.
When is the FDA going to do the right thing and withdraw approval for this !@#$ device? When are the doctors treating the complications patients going to demand it? I am sick and tired of seeing people continue to be harmed unnecessarily.
To compare collared silicone punctal plugs to intracanalicular SmartPlugs for the treatment of moderate to severe dry eye.
Materials and methods:
In this prospective, randomized, single blind, clinical study, 30 patients (60 eyes) who had been diagnosed with moderate to severe dry eye syndrome were enrolled. Study group I (n = 30 eyes) received collared silicone punctal plugs and group II (n = 30 eyes) received intracanalicular SmartPlugs. Data for the Schirmer I test, tear break-up time, vital staining, subjective symptoms and frequency of artificial tear application were recorded at baseline and 3 months after punctal occlusion.
There was no statistical significant difference for these values between group I and II.
Although published data show free flow with irrigation and probing after SmartPlug insertion, the clinical effect in the treatment of dry eye appears to be the equally well to collared silicone punctal plugs. It seems likely that difference of design and localization between the treatment groups were of minor importance concerning impeding of natural and supplemental moisture.
Curr Eye Res. 2013 Feb 12. [Epub ahead of print]
Rabensteiner DF, Boldin I, Klein A, Horwath-Winter J.
Department of Ophthalmology, Medical University of Graz , Austria.