SmartPlug versus silicone punctal plug therapy for dry eye: a prospective randomized trial.
OBJECTIVE
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.
Burgess
Philip I
PI
St John's Hospital, Livingston, UK. philipburgess@doctors.org.uk
Koay
Peter
P
Clark
Patricia
P
D000180:Acrylic Resins; D000328:Adult; D000368:Aged; D015352:Dry Eye Syndromes / Q000628:therapy*; D005260:Female; D019793:Fluorescein; D005456:Fluorescent Dyes; D006801:Humans; D007431:Intraoperative Complications; D007765:Lacrimal Apparatus; D008297:Male; D008875:Middle Aged; D009883:Ophthalmic Solutions / Q000008:administration & dosage; D011183:Postoperative Complications; D011446:Prospective Studies; D019736:Prostheses and Implants; D012395:Rose Bengal; D012826:Silicone Elastomers; D013666:Tears / Q000737:chemistry / Q000378:metabolism; D016896:Treatment Outcome
D000180:Acrylic Resins; D005456:Fluorescent Dyes; D009883:Ophthalmic Solutions; D012826:Silicone Elastomers; D012395:Rose Bengal; D019793:Fluorescein