Study: SmartPlugs vs. silicone punctal plugs

Well, well. After a number of relatively negative studies involving SmartPlugs finally we get an attempt to vindicate them.

But, ahem, not necessarily a terribly effective attempt. 11 weeks is a grossly inadequate follow-up period if you ask me. After all, the key concerns with punctal occlusion are long term safety and retention. Most of us plan on having our plugs in a lot longer than 2.5 months, and many of the reports of SmartPlug problems occurred well beyond that period.

Speaking of which, 33% loss of the punctal plugs within 11 weeks is clearly excessive. I'd like to know how carefully they were sizing these patients before plopping the plugs in and whether the plugs were all one brand. Incidentally, docs, you may find the plugs reference pages in our Dry Eye Encylopedia very handy if you want to get an idea of all the sizes available of all different brands of plugs for those hard-to-fit patients.

SmartPlug Versus Silicone Punctal Plug Therapy for Dry Eye: A Prospective Randomized Trial.
Burgess PI, Koay P, Clark P.
Cornea. 2008 May;27(4):391-394.

PURPOSE:: To evaluate the clinical efficacy, retention rates, and complications of SmartPlug insertion compared with silicone punctal plugs in patients with dry eye. METHODS:: Thirty-six eyes with subjective symptoms of dry eye in addition to a tear film breakup time (TBUT) <5 seconds and evidence of ocular surface damage on rose Bengal or fluorescein staining were included. Treated eyes were randomized to either a silicone plug or SmartPlug inferior punctal occlusion. Pre- and posttreatment evaluations included subjective symptom scoring, tear meniscus height, TBUT, Schirmer test, fluorescein and rose Bengal staining, and artificial tear use. RESULTS:: After a mean follow-up period of 11.2 weeks, both the silicone plug- and SmartPlug-treated eyes showed significant improvement in symptom scoring (P = 0.002 and P = 0.005, respectively), TBUT (P = 0.035 and P = 0.009, respectively), and fluorescein (P = 0.024 and P = 0.016, respectively) and rose Bengal (P = 0.008 and P = 0.046, respectively) staining. There was no significant difference in these parameters between the 2 plugs. SmartPlug-, but not the silicone plug-treated eyes showed significant improvement in mean tear meniscus height (P = 0.037). The use of artificial tear supplements was reduced in 10 (55.6%) silicone- and 11 (61.1%) SmartPlug-treated eyes. Minor complications related to plug insertion were experienced in 4 (22%) silicone- and 2 (11%) SmartPlug-treated eyes. Spontaneous plug loss occurred with 6 (33%) silicone plugs. CONCLUSIONS:: This prospective randomized trial shows that SmartPlug insertion has equivalent clinical efficacy to the use of conventional silicone plugs. Both SmartPlug and silicone plug use can reduce dependency on tear supplements in >55% of patients with dry eye.