How effective and safe are punctal plugs in treating dry eye disease? A systematic review and meta-analysis

Abstract

Background: Dry eye disease (DED) is a common multifactorial condition characterized by tear film instability and ocular discomfort, often treated with punctal plugs to enhance tear retention. Despite their widespread use, the efficacy, safety, and retention profiles of punctal plugs require comprehensive evaluation.

Objectives: To assess the effectiveness and safety of punctal plugs in managing DED, focusing on tear film stability, tear production, symptom relief, ocular surface integrity, and plug retention rates.

Methods: This systematic review and meta-analysis followed PRISMA guidelines and was registered on PROSPERO (CRD42024559417). The search strategy included PubMed, Cochrane Library, Scopus, Web of Science, and Embase for studies published up to January 2025, including randomized controlled trials (RCTs) and cohort studies. Eligible studies involved adults with DED treated with punctal plugs, reporting outcomes such as tear break-up time (TBUT), Schirmer's test, Ocular Surface Disease Index (OSDI) scores, fluorescein and Rose Bengal staining, and retention rates. Data were pooled using fixed- or random-effects models based on heterogeneity (I2 statistic). Risk of bias was assessed with Cochrane RoB2 (RCTs) and ROBINS-I (non-RCTs) tools, and publication bias was evaluated using Begg's and Egger's tests.

Results: Seventeen studies (1,658patients) were included. Punctal plugs significantly improved TBUT (mean difference (MD): 1.8 s; 95 % CI: 1.8-1.9; p < 0.001), Schirmer's test scores (MD: 3.1 mm; 95 % CI: 3.1-3.2; p < 0.001), OSDI scores (MD: -20.6; 95 % CI: -21.3 to -19.9; p < 0.001), fluorescein staining (MD: -1.79; 95 % CI: -1.82 to -1.76; p < 0.001), and Rose Bengal staining (MD: -0.7; 95 % CI: -0.79 to -0.67; p < 0.001). Retention rates were high of 86 % (logit: 1.78; 95 % CI: 1.62-1.94) with smart plug showing high retention of 97.3 %. Heterogeneity was low (I² = 0-24.1 %) across most outcomes. Evidence was moderate to high, supported by RCTs, though some cohort studies exhibited moderate bias in confounding, selection, and outcome measurement. Publication bias was minimal.

Conclusions: Punctal plugs are an effective and safe treatment for moderate-to-severe DED, significantly improving tear film stability, tear production, symptoms, and ocular surface health, with high retention rates. Low heterogeneity and minimal publication bias strengthen these findings, though moderate bias in some non-RCTs suggests caution. Future research should refine plug designs and address methodological limitations to optimize outcomes.

Keywords: Dry eye disease; Meta-analysis; Ocular surface disease index; Punctal plugs; Schirmer’s test; Tear break-up time.