title: Clinical efficacy of the SmartPlug™ in the treatment of primary Sjogren's syndrome with keratoconjunctivitis sicca: one-year follow-up study.
abstract: To evaluate the efficacy of a thermo-sensitive punctum plug, (SmartPlug™) in Primary Sjogren's Syndrome (pSS) patients with dry eyes, whose symptoms persist despite preservative-free artificial tear treatment. In this study, 22 Primary Sjögren's Syndrome (pSS), as defined by American-European Consensus Group Classification Criteria. All patients being followed up by Ege University Departments of Rheumatology and Ophthalmology. The patients had positive Schirmer test results (<5 mm without anesthesia). SmartPlug™ (Medennium, Irvine, California, USA) was inserted into the inferior lacrimal canaliculi of both eyes. Visual acuity measurements, Schirmer I test measurements, lissamine green staining scores, and tear-film breakup times (BUT) were noted before plug insertion and at the 1st, 6th, and 12th months following the procedure. Minimum follow-up period was 6 months for 19 patients and 12 months for 16 patients. Significant improvements were seen in the Schirmer I test scores (before insertion: 1.98 ± 2.67; 1st month: 5.68 ± 6.69; 6th month: 5.35 ± 5.38; 12th month 6.43 ± 5.14 P = 0.006), tear-film BUT in seconds (before insertion: 4.64 ± 3.7; 1st month: 5.80 ± 2.36; 6th month: 7.53 ± 2.92; 12th month 7.50 ± 2.52, P < 0.0001), respectively. Thermodynamic punctum plug insertion only in inferior canaliculus is a simple, effective, and comfortable option for treatment of severe aqueous tear deficiency that cannot be controlled using preservative-free tears.
authors.affiliation: Department of Ophthalmology, Ege University Medical Faculty, Bornova-Izmir, Turkey. saitegrilmez@yahoo.com
authors.forename: Sait
authors.initials: S
authors.lastname: Egrilmez
authors.forename: Fatih
authors.initials: F
authors.lastname: Aslan
authors.forename: Gonca
authors.initials: G
authors.lastname: Karabulut
authors.forename: Yasemin
authors.initials: Y
authors.lastname: Kabasakal
authors.forename: Ayse
authors.initials: A
authors.lastname: Yagci
mesh_terms: D000328:Adult; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007638:Keratoconjunctivitis Sicca / Q000628:therapy*; D007765:Lacrimal Apparatus; D008297:Male; D008875:Middle Aged; D019736:Prostheses and Implants; D012859:Sjogren's Syndrome / Q000628:therapy*; D013816:Thermodynamics; D016896:Treatment Outcome