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Punctal plug: a medical device to treat dry eye syndrome and for sustained drug delivery to the eye. Yellepeddi Venkata K,Sheshala Ravi,McMillan Hannah,Gujral Chirag,Jones David,Raghu Raj Singh Thakur Drug discovery today Punctal plugs (PPs) are miniature medical implants that were initially developed for the treatment of dry eyes. Since their introduction in 1975, many PPs made from different materials and designs have been developed. PPs, albeit generally successful, suffer from drawbacks such as epiphora and suppurative canaliculitis. To overcome these issues intelligent designs of PPs were proposed (e.g. SmartPLUG™ and Form Fit™). PPs are also gaining interest among pharmaceutical scientists for sustaining drug delivery to the eye. This review aims to provide an overview of PPs for dry eye treatment and drug delivery to treat a range of ocular diseases. It also discusses current challenges in using PPs for ocular diseases. 10.1016/j.drudis.2015.01.013
Effects of punctal occlusion on global tear proteins in patients with dry eye. Tong Louis,Zhou Lei,Beuerman Roger,Simonyi Susan,Hollander David A,Stern Michael E The ocular surface PURPOSE:To investigate effects of punctal occlusion on global tear protein levels in patients with dry eye. METHODS:In this prospective, longitudinal, single-center study, nonabsorbable punctal plugs were inserted bilaterally into the lower punctum of 30 patients with moderate dry eye. Dry eye symptoms, fluorescein corneal staining, Schirmer I test, tear film break-up time, and safety were assessed in the more severely affected eye. Tear proteins at weeks 1 and 3 were quantified by iTRAQ relative to baseline preocclusion levels. RESULTS:Of 29 patients who completed the study, 23 (mean age 49.8 years) had sufficient tear samples for analysis. After 3 weeks, punctal occlusion significantly upregulated tear proteins, including glutathione synthase (mean of 1.6-fold, P = 0.01) and interleukin-1 receptor antagonist (1.7-fold, P = 0.032) and downregulated cholinergic receptor (neuronal) alpha-7 (0.79-fold, P = 0.039) and lymphocyte cytosolic protein-1 (0.66-fold, P = 0.012). Clustering analysis of global tear proteins revealed two clear profile changes; the first group of patients (cluster 1, n = 10) had a reduction in the inflammatory proteins (e.g., S100A8) and rise in lacrimal proteins supporting the ocular surface (e.g., lysozyme), whereas the second group (cluster 2, n = 13) had an increase in inflammatory proteins and a decrease in lacrimal proteins. Logistic regression analysis revealed that cluster 1 patients had significantly (P = 0.006) lower Schirmer scores at baseline (mean [standard deviation]: 4.3 [4.3] mm) than cluster 2 (6.8 [2.6] mm). CONCLUSIONS:Punctal plugs produced a beneficial pattern of tear protein change in patients with relatively low Schirmer scores within 3 weeks of punctal occlusion. 10.1016/j.jtos.2017.04.002
Effects of Punctal Occlusion on Clinical Signs and Symptoms and on Tear Cytokine Levels in Patients with Dry Eye. Tong Louis,Beuerman Roger,Simonyi Susan,Hollander David A,Stern Michael E The ocular surface PURPOSE:To investigate changes in signs, symptoms, and tear cytokines following punctal plug occlusion in patients with dry eye. METHODS:A single-center study was conducted at Singapore Eye Research Institute. Nonabsorbable punctal plugs were inserted in the lower punctum of both eyes in patients with moderate dry eye. Over 3 weeks, in the more severe eye, dry eye symptoms, fluorescein corneal staining, Schirmer I (without topical anesthesia) test, tear film breakup time (TFBUT), and safety were assessed. Cytokine and matrix metalloproteinase-9 (MMP-9) levels in tear samples were measured. RESULTS:Twenty-nine patients (mean age 49.8 years) with moderate dry eye were evaluated. At baseline, mean (standard deviation) global symptoms score was 53.8 (26.5), Schirmer I test score was 5.1 (2.8) mm, and TFBUT was 2.2 (0.6) seconds. After 3 weeks, punctal occlusion significantly reduced global irritation symptoms score (P<.001) and decreased fluorescein staining in all zones (P<.01) except the inferior zone (P=.42). No significant association between levels of cytokines or MMP-9 and either TFBUT or global irritation symptoms were observed at baseline. Levels of several cytokines and MMP-9 were higher in patients with Schirmer I test scores ≤8 mm at baseline. After 3 weeks of punctal occlusion, no significant changes in overall cytokine or MMP-9 levels were observed. CONCLUSIONS:Punctal plug occlusion provided symptomatic relief and reduced fluorescein staining in all except the inferior zone. However, insertion of punctal plugs had minimal effect on tear cytokines and MMP-9 levels, suggesting a need for earlier treatment with anti-inflammatory agents for management of dry eye disease. 10.1016/j.jtos.2015.12.004
Safety and Efficacy of Lacrimal Drainage System Plugs for Dry Eye Syndrome: A Report by the American Academy of Ophthalmology. Marcet Marcus M,Shtein Roni M,Bradley Elizabeth A,Deng Sophie X,Meyer Dale R,Bilyk Jurij R,Yen Michael T,Lee W Barry,Mawn Louise A Ophthalmology OBJECTIVE:To review the published literature assessing the efficacy and safety of lacrimal drainage system plug insertion for dry eye in adults. METHODS:Literature searches of the PubMed and Cochrane Library databases were last conducted on March 9, 2015, without date restrictions and were limited to English language abstracts. The searches retrieved 309 unique citations. The primary authors reviewed the titles and abstracts. Inclusion criteria specified reports that provided original data on plugs for the treatment of dry eyes in at least 25 patients. Fifty-three studies of potential relevance were assigned to full-text review. The 27 studies that met the inclusion criteria underwent data abstraction by the panels. Abstracted data included study characteristics, patient characteristics, plug type, insertion technique, treatment response, and safety information. All studies were observational and rated by a methodologist as level II or III evidence. RESULTS:The plugs included punctal, intracanalicular, and dissolving types. Fifteen studies reported metrics of improvement in dry eye symptoms, ocular-surface status, artificial tear use, contact lens comfort, and tear break-up time. Twenty-five studies included safety data. Plug placement resulted in ≥50% improvement of symptoms, improvement in ocular-surface health, reduction in artificial tear use, and improved contact lens comfort in patients with dry eye. Serious complications from plugs were infrequent. Plug loss was the most commonly reported problem with punctal plugs, occurring on average in 40% of patients. Overall, among all plug types, approximately 9% of patients experienced epiphora and 10% required removal because of irritation from the plugs. Canaliculitis was the most commonly reported problem for intracanalicular plugs and occurred in approximately 8% of patients. Other complications were reported in less than 4% of patients on average and included tearing, discomfort, pyogenic granuloma, and dacryocystitis. CONCLUSIONS:On the basis of level II and III evidence in these studies, plugs improve the signs and symptoms of moderate dry eye that are not improved with topical lubrication, and they are well tolerated. There are no level I studies that describe the efficacy or safety of lacrimal drainage system plugs. 10.1016/j.ophtha.2015.04.034