Evaluation of implanted perforated lacrimal punctal plugs using anterior segment optical coherence tomography

Purpose Evaluation of the patency and position of perforated lacrimal punctal plugs implanted for treating punctal stenosis together with quantitative assessment of the precorneal tear film using anterior segment optical coherence tomography (AS-OCT). Methods In a prospective study, the lower punctum of 54 eyes of 29 patients implanted with perforated punctal plugs were examined using AS-OCT during the early postoperative period. Preoperative tear meniscus height (TMH) and tear meniscus area (TMA) were evaluated. Postoperatively, the patency of the plug, its position, TMH and TMA were evaluated, and the results were correlated with postoperative epiphora. Munk scale was used for epiphora grading. Results Using AS-OCT, 48 (88.9%) plugs were found in proper position while 6 (11.1%) were rotated. The lumen of the plugs was completely patent in 47 (87%) plugs, partially obstructed in 2 (3.7%) plugs and completely occluded in 5 (9.2%) plugs. There was a statistically significant postoperative decrease of TMH and TMA (P < 0.001) and postoperative epiphora Munk score (P < 0.001). Conclusion AS-OCT is a valuable, reliable, and noninvasive investigative tool that can detect the proper positioning, patency, and contents of the implanted perforated lacrimal punctal plugs in addition to measurement of TMH and TMA. Trial registration ClinicalTrials.gov ID: NCT04624022, https://clinicaltrials.gov/ct2/show/NCT04624022

3D Printed Punctal Plugs for Controlled Ocular Drug Delivery

Dry eye disease is a common ocular disorder that is characterised by tear deficiency or excessive tear evaporation. Current treatment involves the use of eye drops; however, therapeutic efficacy is limited because of poor ocular bioavailability of topically applied formulations. In this study, digital light processing (DLP) 3D printing was employed to develop dexamethasone-loaded punctal plugs. Punctal plugs with different drug loadings were fabricated using polyethylene glycol diacrylate (PEGDA) and polyethylene glycol 400 (PEG 400) to create a semi-interpenetrating network (semi-IPN). Drug-loaded punctal plugs were characterised in terms of physical characteristics (XRD and DSC), potential drug-photopolymer interactions (FTIR), drug release profile, and cytocompatibility. In vitro release kinetics of the punctal plugs were evaluated using an in-house flow rig model that mimics the subconjunctival space. The results showed sustained release of dexamethasone for up to 7 days from punctal plugs made with 20% w/w PEG 400 and 80% w/w PEGDA, while punctal plugs made with 100% PEGDA exhibited prolonged releases for more than 21 days. Herein, our study demonstrates that DLP 3D printing represents a potential manufacturing platform for fabricating personalised drug-loaded punctal plugs with extended release characteristics for ocular administration.

Lacrimal stenting versus three-snip punctoplasty for treatment of punctal stenosis or occlusion: An open-label, randomized clinical trial

Background: To compare the short-term anatomical and functional outcomes of, as well as patient satisfaction with, lacrimal stenting and three-snip punctoplasty for the treatment of punctal stenosis or occlusion. Methods: In this open-label, randomized clinical trial, we included 50 eyes of 30 patients diagnosed with punctal stenosis or occlusion. They were randomly allocated to two groups of 25 eyes each, using central telephone randomization. Group A underwent a lacrimal stenting procedure and was subdivided into two subgroups: Group A1 (13 eyes) received polyvinylpyrrolidone-coated perforated punctal plugs, and Group A2 (12 eyes) received closed intubation using a bicanalicular silicon tube. Group B included 25 eyes that underwent three-snip punctoplasty. All eyes were examined after 1 day, 1 week, 1 month, 3 months, and 6 months. Postoperative anatomical success assessing the punctum size, functional success using the fluorescein disappearance test, and patient satisfaction based on epiphora scoring were recorded. Results: Both study groups were comparable in terms of sex and age distribution. Compared to Group B, Group A had a significantly larger punctum size at one, three, and 6-month postoperatively (P = 0.009, 0.01, and 0.02, respectively). The difference in FDT results was significant between the two groups at all follow-up visits (P = 0.008, 0.0001, 0.003, and 0.002, at postoperative one week, one-months, three-month, and six-month, respectively). Likewise, patient satisfaction was significantly different between both groups at all follow-up visits (P = 0.007, 0.001, 0.005, and 0.002, at postoperative one week, one-months, three-month, and six-month, respectively). Conclusions: Lacrimal stenting is an effective method for the treatment of punctal stenosis or occlusion. Overall, the FDT results and patient satisfaction outcomes were significantly better. Keywords: punctal occlusion, punctal stenosis, epiphora, lacrimal stenting, closed intubation, bicanalicular silicon tube, perforated punctal plugs, three-snip punctoplasty, 3-snip punctoplasty

Efficacy of omega-3 fatty acids and punctal plugs in the prevention of isotretinoin-associated ocular surface disease

Purpose: To investigate the effects of omega-3 fatty acids and punctal plugs on tear film and ocular surface parameters in patients receiving systemic isotretinoin therapy. Methods: This is a prospective randomized study that included 180 eyes of 90 patients who had systemic isotretinoin therapy (120–150 mg/kg for at least 4–6 months). Exclusion criteria: DED according to the diagnostic criteria of TFOS DEWS II. Patients were assigned into three groups; (1) O3FAs/PPs group: A soft preloaded silicone plug was inserted in the inferior punctum of both eyes and received oral O3FAs two capsules twice daily total daily dose of 1040 mg/day for 6 months. (2) PPs group: A soft preloaded silicone plug was inserted in the inferior punctum of both eyes and received oral placebo. (3) Isotretinoin group: No intervention was done. At baseline, 1 week, 1, 3, and 6 months of study, Ocular surface evaluation tests were done in following order: OSDI, tear osmolarity, Schirmer’s I test, TBUT, ocular surface staining score, and meibomian gland expression. Primary outcome measures: The changes in measurement of ocular surface evaluation tests including ocular surface disease index (OSDI), tear film breakup time (TFBUT), corneal staining, tear osmolarity, and meibomian gland expression at 6 months. Results: There are significant changes between all groups at 6 months follow-up. The ocular surface parameters were better for the PPs and O3FAs/PPs groups than the isotretinoin group. The isotretinoin group showed worsening of ocular surface parameters including a significant decrease of FTBUT and an increase of OSDI score, corneal staining score, tear osmolarity, and meibomian expression score. There was no significant difference in ST1 throughout the whole study in all groups. At 6 months follow-up, there were no statistically significant differences between PPs and O3FAs/PPs groups except meibomian expression score which showed a significant increase in PPs group. Conclusion: Our cohort highlights the beneficial effects of the combination of O3FAs supplementation with PPs in the prevention of isotretinoin-associated OSD in this sample study.

Three-snip punctoplasty versus perforated plugs for management of lacrimal punctal stenosis

Purpose To compare rectangular three-snip punctoplasty and polyvinylpyrrolidone-coated perforated punctal plugs for treatment of acquired lacrimal punctal stenosis. Patients and methods In a prospective comparative non-randomized interventional study, 80 eyes with acquired lacrimal punctal stenosis were classified into two groups. Group A was treated by insertion of polyvinylpyrrolidone-coated perforated punctal plugs (FCI ophthalmics)™ and Group B was treated by rectangular three-snip punctoplasty. The study was done in Minia University Hospital between January 2018 and April 2019. Exclusion criteria included allergic punctal stenosis, lid malposition, and lacrimal obstruction distal to the punctum. All patients were subjected to complete history taking, slit lamp examination of tear meniscus height, fluorescein dye disappearance test, punctal position, shape, size, grading of stenosis, and grading of epiphora. Results The mean age of the patients was 43.85 ± 14.93 years. They were 30 females and 10 males. Eepiphora Grade 3 or 4, improved postoperatively to Grade 0 or 1 in 97.5% of eyes in Group A versus 55% of eyes in Group B. All eyes (100%) in Group A versus 21 eyes (52.5%) in Group B improved regarding fluorescein dye disappearance test grade ( p < 0.001). Restenosis did not occur after plug removal, while it occurred in 10% of eyes subjected to three-snip punctoplasty. Conclusion Perforated punctal plugs and three-snip punctoplasty are safe and effective in treatment of punctal stenosis. However, perforated plugs are less invasive, better tolerated, and have more stable results compared to three-snip punctoplasty.

Role of punctal plugs as a primarily treatment modality in moderate to severe dry eye

<p class="abstract"><strong>Background:</strong> In dry eye syndrome tear film disrupts which lead to ocular discomfort. Treatment of dry eye is very challenging and time consuming. Multiple treatment options are available for treating dry eye and one of them is punctal plugs. It blocks the drainage of tear by occluding puncta which helps in the preservation of natural tears on the ocular surface and relieve dry eye symptoms. This study was conducted to assess the safety and efficacy of punctal plugs as a primary treatment modality in moderate to severe dry eye.</p><p class="abstract"><strong>Methods:</strong> Fifty patients were included in this study and they were divided into two groups. In group A which included 25 patients punctal plugs were inserted and in group B (25 patients or 50 eyes) artificial tear drop was prescribed. The primary treatment outcome was the improvement in dry eye symptoms and secondary outcome was Schirmer test score, tear break up time and rose bengal staining score.</p><p class="abstract"><strong>Results:</strong> There was drastic improvement in dry eye symptoms in group A (punctal plugs) compared to group B (artificial tear group). Schirmer test score, tear break up and rose bengal staining score also improved in punctal plug group.</p><p class="abstract"><strong>Conclusions: </strong>This study has shown that punctal plug can be used as a primary treatment modality in moderate to severe dry eye as it improves greater symptomatic relief and also improves the condition of damaged ocular surface.</p>