Punctal plugs for dry eye syndrome
Dry eye syndrome, which affects 10% to 20% of adults, is a disorder of the eye's tear film and is associated with symptoms such as burning, foreign body sensation, and fluctuating vision. Punctal plugs are inserted into a small opening in the upper and/or lower eyelid. Seven randomized controlled trials (with a total of 305 participants and 601 eyes) were identified. These trials compared silicone and/or collagen punctal plugs to each other, no treatment, acrylic punctal plugs, or oral pilocarpine (a drug used to increase tear production). Punctal plugs provided symptomatic improvement and clinical outcomes also improved from baseline measurements. Adverse outcomes included epiphora (overflow of tears), foreign body sensation, eye irritation, and spontaneous plug loss. Although individual trials reported improvements among participants assigned to punctal plugs, these trials were too diverse to summarize the effects across all studies.
Background: Dry eye syndrome is a disorder of the tear film and is associated with symptoms of ocular discomfort. Punctal occlusion is a mechanical treatment in which the tear drainage system is blocked in order to aid in the preservation of natural tears on the ocular surface.
Objectives: The objective of this review was to assess the safety and efficacy of punctal plugs for the management of dry eye.
Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (which contains the Cochrane Eyes and Vision Group Trials Register) (The Cochrane Library 2010, Issue 6), MEDLINE (January 1950 to June 2010), EMBASE (January 1980 to June 2010), Latin American and Caribbean Literature on Health Sciences (LILACS) (January 1982 to June 2010), the metaRegister of Controlled Trials (mRCT) (www.controlled‐trials.com) and ClinicalTrials.gov (http://clinicaltrials.gov). We also searched the Science Citation Index‐Expanded database and reference lists of included studies. There were no language or date restrictions in the search for trials. The electronic databases were last searched on 21 June 2010.
Selection criteria: We included randomized and quasi‐randomized controlled trials of collagen or silicone punctal plugs in symptomatic participants diagnosed with aqueous tear deficiency or dry eye syndrome.
Data collection and analysis: Two review authors independently assessed trial quality and extracted data. We contacted study investigators for additional information.
Main results: Seven randomized controlled trials including 305 participants (601 eyes) met the inclusion criteria and are summarized in this review. We did not perform meta‐analysis due to appreciable variability in interventions and follow‐up intervals. Although punctal plugs provided symptomatic improvement and clinical outcomes also improved from baseline measures, few studies demonstrated a benefit of punctal plugs over the comparison intervention. Reported adverse effects included epiphora (overflow of tears), foreign body sensation, eye irritation, and spontaneous plug loss.
Authors' conclusions: This systematic review shows a relative scarcity of controlled clinical trials assessing the efficacy of punctal occlusion therapy in dry eye. Although the evidence is very limited, the data suggest that silicone plugs can provide symptomatic relief in severe dry eye. Moreover, temporary collagen plugs appear similarly effective to silicone plugs on a short‐term basis.
Editorial Group: Cochrane Eyes and Vision Group.