Canalicular stenoses complicating the insertion of lacrimal plugs. Incidence and mechanisms]

Changes in canalicular permeability following the insertion of punctum plugs was studied. This occlusive method was used to treat dry eye syndrome in 43 patients over a period of 32 months. All had normal canalicular patency, confirmed on the day of implantation. One hundred and five large plugs were used (2.4 plugs per patient). Twenty seven (25.7%) impassable acquired canalicular stenoses were seen in 15 patients. The canalicular site of the 27 stenoses was the same: junction between the vertical and horizontal portions. Among the 27 stenoses: 4 plugs had disappeared at an unknown time, with follow-up probing taking place after a mean interval of 7.5 (months range: 1 to 15 months); 17 plugs had been expelled after being in place for an average of 5 months (range: 1 to 12 months; standard deviation 3.47), with follow-up examination taking place on average 12 months after insertion (range: 6 to 17 months; standard deviation 3.4); and 6 plugs were still in place after a mean of 7 months (range: 2 to 15 months; standard deviation 4.73) and the stenosis was discovered when they were removed. They were intact. These 6 Cases eliminate any possibility of intra-canalicular migration of the prosthesis--of all or part--of the prosthesis. Stenoses appeared to develop rapidly: 45% of cases were discovered during the first 3 months. 16/27 (59%) of stenoses were investigated a second time, 6 months later on average (range: 2 to 12 months): these 16 canaliculi all remained impassable.     

泪道塞置入术治疗干眼症的临床研究进展

泪道塞置入术是一种通过栓塞泪道减少泪液从泪道流失来治疗严重干眼症的方法。随着泪道塞的改良和新型泪道塞的不断出现,泪道塞置入术逐渐被推广使用,人们对其临床适应证、禁忌证、不良反应及处理都有了新的认识,本文就其临床应用新进展进行综述,为临床合理使用提供参考。     

聚乳酸可降解泪道塞的初步实验研究

目的:自主开发研制出一种可降解泪道塞。方法:选择聚乳酸为原材料,经过加热塑形裁切得到泪道塞;采取摘除主泪腺、摘除第三眼睑、摘除Harder氏腺,得到兔干眼动物模型;观察植入泪道塞前后,泪液分泌试验、热原实验;观察泪道塞组织相容性及降解时间。结果:泪道塞植入后,能明显改善兔干眼模型泪液分泌试验观察指标,无热原反应,组织相容性佳,完全降解时间约为2mo。结论:广泛用于生物医学领域的聚乳酸材料制备的可降解泪道塞对兔无毒害作用,具有极好的安全性及生物相容性,成本低,具有进一步研究价值及临床应用前景。     

Clinical investigation of extrusion of a new punctal plug(Flex Plug)

PURPOSE: Punctal occlusion using punctal plugs is very effective for the treatment of tear-deficient dry eye. We compared the newly marketed Flex Plug (FP, Eagle Vision Co., Ltd.) and the Eagle Plug (EP, Eagle Vision Co., Ltd.). SUBJECTS AND METHODS: The subjects were patients with severe tear-deficient dry eye who were treated in our dry eye clinic. FP plugs in 8 patients (9 eyes) and EP plugs in 29 patients (35 eyes) were compared during over 4 months of observation with regard to the time until extrusion and the possibility for re-insertion of the plugs. RESULTS: During the 4 months after insertion of the plugs, the EP plugs were extruded from 35 of 51 puncta (68.6%) and the FP plugs were extruded from 4 of 13 puncta (30.8%). In the 35 EP extrusions and in the 4 FP extrusions, re-insertion was possible. The time period until extrusion was longer for FP than for EP. In all cases, for both EP and FP, pyogenic granuloma was not observed. DISCUSSION: The extrusion rate for EP plugs was much greater than for FP plugs (68.6% to 30.8%). Pyogenic granuloma was not observed in any instance for both types of punctal plugs.     

Smart PLUG泪小管栓子对干眼症治疗的初步评价

目的评价Smart PLUG泪小管栓子在干眼症治疗中的效果。方法 13例水液性泪液不足型(aque- ous tear deficiency,ATD)干眼症患者,其中Sjogren’s syndrome(SS)4例(8只眼),非Sjogren's syndrome9例(18只眼),应用Smart PLUG泪小管栓子治疗,在治疗前及治疗后1d、10 d、1m、3m分别对视力、干眼症状、泪河线、泪膜破裂时间(BUT)、Schirmer I a实验、荧光素染色(Fl)、每日需用人工泪液次数及治疗后可能出现的副反应进行检查并记录。结果应用Smart PLUG泪小管栓子治疗干眼后不同时间两组患者的干眼症状均有不同程度改善,每日需用人工泪液次数明显减少,最佳矫正视力不同程度提高,泪河线增加;BUT延长、基础泪液分泌增加、荧光素染色评分下降,与治疗前比较差异均具有显著性(P<0．05)。治疗期间未观察到副反应发生。结论Smart PLUG泪小管栓子可用于干眼的治疗,是治疗干眼症简便、安全的方法。     

A review of the complications of lacrimal occlusion with punctal and canalicular plugs

Punctal and canalicular plugs are widely used for both temporary and permanent occlusion of the lacrimal puncta in dry eyes. There are many designs and materials available on the market. While their efficacy in improving dry eye symptoms is widely proven, the gamut of complications associated with these devices have never been subject to a general review, although there are numerous case series in the literature associated with one particular device. This review aims to examine the track record of a variety of plugs currently in use, to review the management of complications, and propose strategies for both the prevention of these complications and their treatment.     

A Review of the Complications of Lacrimal Occlusion with Punctal and Canalicular Plugs

Punctal and canalicular plugs are widely used for both temporary and permanent occlusion of the lacrimal puncta in dry eyes. There are many designs and materials available on the market. While their efficacy in improving dry eye symptoms is widely proven, the gamut of complications associated with these devices have never been subject to a general review, although there are numerous case series in the literature associated with one particular device. This review aims to examine the track record of a variety of plugs currently in use, to review the management of complications, and propose strategies for both the prevention of these complications and their treatment.     

The treatment of aqueous-deficient dry eye with removable punctal plugs. A clinical and impression-cytologic study

Punctal plugs were placed in 18 dry eye patients of the aqueous-deficiency type who were on maximally tolerable medical therapy and who had Schirmer testing with topical anesthetic measuring less than 6 mm. Pretreatment and posttreatment evaluations included rose Bengal and fluorescein staining, Schirmer testing, and conjunctival impression cytology. Six weeks after plug placement, 11 of 18 patients had subjective improvement and were able to decrease dependency on tear supplements; all of these patients have successfully worn plugs for at least 8 months. Although these 11 patients improved clinically, impression cytologic abnormalities persisted 6 weeks after plug placement. Three patients did not improve clinically after punctal plug therapy, and four patients improved subjectively but extruded plugs within 2 weeks of placement. Three of the patients who extruded plugs had marked lid laxity and dilated puncta before placement. Reversible punctal occlusion by plugs may significantly decrease dependency on tear supplements in selected patients.     

Effects of lacrimal occlusion with collagen and silicone plugs on patients with conjunctivitis associated with dry eye

PURPOSE: To determine whether canalicular occlusion with collagen and silicone plugs reduces the severity of symptoms in patients with conjunctivitis secondary to dry eye. METHODS: This was a prospective, randomized, double-masked study conducted at a single center in Mexico, in which 61 patients with dry eye/conjunctivitis were assigned to progressive lacrimal occlusion with collagen and silicone plugs or a sham procedural group. Outcome variables included total and individual dry eye and conjunctivitis symptom scores, moisturizing agent usage, best-corrected visual acuity, ocular comfort level, visual performance, corneal/conjunctival fluorescein staining, and incidence of adverse events. RESULTS: Total dry eye and conjunctival symptom scores were reduced by 43.7 and 33.7%, respectively 2 weeks after occlusion of all four lacrimal canaliculi with collagen plugs, increasing to 77.4 and 72.1% 2 weeks later following superior canalicular occlusion of both eyes with silicone plugs and inferior placement of collagen plugs. At the 8-week visit (4 weeks after silicone plug implantation of the inferior canaliculi of both eyes), the reduction in total dry eye and conjunctival symptom scores further increased to 94.2 and 93.0%, respectively, accompanied by a marked decline in each of the seven individual symptom scores (dryness, watery eyes, itching, burning, foreign body, fluctuating vision, and light sensitivity). In concert with these changes, moisturizing agent usage and corneal/conjunctival fluorescein staining decreased in a progressive fashion over the 8-week study period, and best-corrected visual acuity, ocular comfort, and visual performance improved in the absence of any treatment-related adverse events except for one case of epiphora. The response of patients to lacrimal occlusion can be sharply contrasted with the sham procedure group, which remained relatively unchanged from baseline at each of the study visits. CONCLUSIONS: Progressive lacrimal occlusion with collagen and silicone plugs was of clinical benefit to patients with dry eye and conjunctivitis.     

Silicone versus collagen plugs for treating dry eye: results of a prospective randomized trial including lacrimal scintigraphy

PURPOSE: To compare the short-term efficacy of collagen and silicone plugs for treating dry eye using quantitative lacrimal scintigraphy. DESIGN: Prospective randomized clinical trial. METHODS: In this institutional study, 24 dry eye patients were evaluated in two groups: group I (n = 22 eyes) received collagen plugs and group II (n = 26 eyes) received silicone plugs. Comparisons were made with normal control subjects (n = 22 eyes). Data for the Schirmer I test, tear break-up time, and ocular surface staining with rose bengal dye were recorded before and after punctal occlusion. Lacrimal scintigraphy was performed at each time point, and the time to half maximum activity on the ocular surface (T(1/2)), and the percentage retention of activity on the ocular surface at the end of the dynamic study (RI) were recorded. RESULTS: In both patient groups, Schirmer I results, tear break-up times, and rose bengal staining scores improved significantly after plug insertion. Mean T(1/2) values and RI values increased significantly in both groups (P < .0001 for both). The differences for these values between groups I and II was statistically insignificant (P > .05). CONCLUSIONS: Collagen and silicone plugs both resulted in significant increases in aqueous tear volume, half-life of nuclear material on the ocular surface, and percentage of nuclear material retention. The groups' post-insertion values for all parameters were similar. These results suggest that these two plug types have similar efficacy as treatments for dry eye in the short term. Further studies evaluating long-term results are required.     

Lacrimal duct occlusion for the treatment of dry eye

The most widespread treatment for dry eyes in clinical practice is an instillation containing artificial tear fluid. When an instillation does not ameliorate dry eye, we use punctal plugs. The insertion of punctal plugs is an eminent curative that positively improves the corneal and conjunctival epithelial disorders and the amount of lacrimal fluid accumulated in the conjunctival sac. We shall introduce the lacrimal duct occlusion utilizing atelocollagen solutions, which solves many of the issues induced by conventional methods.     

Lacrimal Duct Occlusion for the Treatment of Dry Eye

The most widespread treatment for dry eyes in clinical practice is an instillation containing artificial tear fluid. When an instillation does not ameliorate dry eye, we use punctal plugs. The insertion of punctal plugs is an eminent curative that positively improves the corneal and conjunctival epithelial disorders and the amount of lacrimal fluid accumulated in the conjunctival sac. We shall introduce the lacrimal duct occlusion utilizing atelocollagen solutions, which solves many of the issues induced by conventional methods.     

The application of a new continuous functional visual acuity measurement system in dry eye syndromes

PURPOSE: To evaluate the efficacy of a new continuous functional visual acuity measurement (FVAM) system for the assessment of dry eye patients. DESIGN: Prospective comparative study. METHODS: Monocular recognition acuity measured continuously by the FVAM system during a 30-second blink-free period was defined as functional visual acuity (FVA). Examinations using the FVAM system were conducted in 35 eyes of 20 healthy controls and 19 eyes of 13 dry eye patients. Tear function examinations including the Schirmer test, tear film break-up time, and fluorescein and Rose Bengal staining were performed in all subjects. Functional visual acuity and tear functions were also examined before and after insertion of punctum plugs in dry eye patients. Functional visual acuity results at 10, 20, and 30 seconds were compared. RESULTS: Functional visual acuity in dry eyes were significantly lower than control subjects at all time points (P < .05). Functional visual acuity after punctum plugs insertion improved significantly at all time points (P < .05). CONCLUSIONS: FVAM system seemed not only to be an effective tool in the assessment of dynamic visual acuity changes in dry eye and normal subjects but in evaluating the outcome of management of dry eye disease by punctum plugs.     

Efficacy and tolerability outcomes after punctal occlusion with silicone plugs in dry eye syndrome

PURPOSE: Silicone punctal plugs are widely used to conserve moisture in tear-deficient eyes. We studied the efficacy and tolerability of punctal plugs in symptom reduction and improvement of ocular surface disease parameters in dry eye syndrome.METHODS: We reviewed the records of 50 consecutive patients with dry eye syndrome who were symptomatic despite maximally tolerable lubricant therapy and had bilateral lower punctal plug insertion. After plug insertion, all patients (41 women and nine men) had 6 months or more of follow-up. The subjects ranged in age from 22 to 57 years (mean, 30 years). We recorded subjective and objective improvement of ocular surface disease, frequency of lubricant use, need for upper punctal occlusion, and occurrence of complications after plug insertion. We determined plug retention rates using Kaplan-Meier analyses and assessed associated factors using Cox proportional hazards models.RESULTS: Six months after initial plug placement, 43 of 50 patients (86%) were symptom free, 28 of them (56%) with plugs alone, and 38 patients (76%) had stopped using lubricants on a daily basis. Spontaneous loss of plugs was common, especially in the initial 3 months of follow-up. Considering all plugs, the estimated probability of plug retention was 63% after 6 months of follow-up. Puncta refitted after initial plug loss were twice as likely to lose the replacement plug (P =.02). Upper punctal plugs showed a 4.3-fold higher risk of loss compared with plugs inserted in lower puncta (P <.0001).CONCLUSIONS: There is both a reduced dependency on artificial lubricants and relief of symptoms of dry eye after punctal plugs. However, spontaneous plug loss occurs in a substantial minority of patients. Patient education and close follow-up, particularly in the first 3 months, is recommended to detect plug loss and ensure adequate control of the disease.     

Long-term retention rates and complications of silicone punctal plugs in dry eye

PURPOSE: To evaluate long-term retention rates and complications of silicone punctal plugs among dry eye patients. DESIGN: Prospective, observational cohort study. METHODS: Ninety-five silicone punctal plugs (FCI plugs; FCI Ophthalmics, Issy-les-Moulineaux Cedex, France) were placed in 93 eyes of 47 dry eye patients. Within the observation period of up to eight years, this survey included recording of the retention rate, spontaneous loss, removal, canalicular permeability after loss or removal, as well as other complications such as infection, intrusion, and granuloma. RESULTS: The retention rate of the plugs was 84.2% after three months, 69.5% after one year, and 55.8% after a median of two years (range, 17 to 93 months). No infection was observed, but granulomatous formation occurred in three eyes (one with extrusion, two with intrusion). Three plugs had to be removed for local discomfort or epiphora, and one piece of a broken plug intruded. Canalicular stenosis after spontaneous loss occurred in 14.3% after three months, in 26.9% after one year, and in 34.2% after a median of two years. CONCLUSIONS: The retention rate after a median of two years of FCI punctal plugs was satisfactory with few complications. The major observation concerned canalicular stenosis after spontaneous loss.     

A technique for preventing spontaneous loss of lacrimal punctal plugs

PURPOSE: To describe a technique for the prevention of spontaneous loss of lacrimal punctal plugs. DESIGN: Interventional case series. METHODS: Four consecutive patients (10 puncta in seven eyes) with severe dry eyes who experienced repeated spontaneous plug loss underwent punctal occlusion by suturing plugs with 10-0 polypropylene sutures. RESULTS: All punctal plugs were fitted to lacrimal puncta by anchoring the sutures. Plug retention rate was 80% at 6 months after the procedure. CONCLUSION: Suturing punctal plugs is effective in the production of long-term punctal closure in patients with repeated spontaneous plug loss.     

泪道塞在LASIK术后的早期应用

目的:探讨泪道塞在LASIK术后早期对干眼症状的影响。方法:随机选取在我院接受LASIK手术的患者54例108眼,其中27例54眼术后第2d植入诊断性泪道塞,另外27例54眼给予倍然眼药水点眼,于术后2wk进行泪液分泌试验(SchirmerⅠtest,SⅠt)、泪膜破裂时间(breaking-uptime,BUT)和荧光素染色(FL)评分。结果:泪道塞组与倍然组泪液分泌实验结果分别为11.90±4.20,10.85±3.42mm/5min,两组间差异无统计学意义(P>0.05)。泪道塞组与倍然组BUT分别为13.12±2.58和11.67±3.29s,两组间无统计学差异(P>0.05)。泪道塞组与倍然组FL评分分别为6.23±1.12和5.42±2.10分,差异无统计学意义(P>0.05)。结论:泪道塞在LASIK术后早期缓解干眼症状中与人工泪液具有相同的作用。     

Pyogenic granuloma: a rare complication of silicone punctal plugs

To describe pyogenic granuloma formation associated with silicone punctal plugs. A 65-year-old woman with severe dry eye was treated with silicone punctal plugs in both upper and lower puncta. After 14 months of success with the plugs, the patient presented with a fleshy ampullary lesion overlying the plugged superior punctum of her right eye. It was clinically diagnosed as a pyogenic granuloma, and the silicone plug was removed. Since the lesion persisted for 1 month, it was surgically removed. Histopathologic examination confirmed the diagnosis of pyogenic granuloma. A new plug was inserted and tolerated well. The routine use of silicone plugs are recommended as long as patients are informed of possible rare complications.     

Corneal topographical study of the effect of lacrimal punctum occlusion on corneal surface regularity in dry eye patients.

PURPOSE: To compare topographic indices of surface regularity in dry eye patients and in normal subjects (controls) and to investigate the short-term effect of lacrimal punctal plugs on these indices in dry eye patients. METHODS: The surface regularity index (SRI) and surface asymmetry index (SAI) of the TMS-2 corneal topographic modelling system were used to evaluate corneal surface regularity in 20 eyes of 10 dry eye patients before and after the insertion of Herrick silicon lacrimal plugs (Lacrimedics, Rialto, CA, USA) and in 24 eyes of 12 normal subjects as controls. RESULTS: SRI and SAI were significantly lower in controls than dry eye patients (p=0.00). Median SRI was 1.72 in dry eye patients before punctal occlusion and 0.525 in the control group. Median SAI was 1.305 in dry eye patients and 0.240 in controls. After lacrimal punctal occlusion, Schirmer test results and fluorescein breakup time increased in nine patients and remained the same in one patient. After occlusion, the SRI decreased in 9 eyes, and increased in 11 (p=0.970); SAI decreased in 13 eyes and increased in 7 (p=0.135). CONCLUSIONS: No significant change in topographic indices of corneal surface irregularity could be detected in severe dry eye patients with lacrimal punctal plugs in the short-term follow-up.     

Punctal plugs in the management of dry eyes

Punctal plugs appear to be a relatively safe, effective, and reversible method of preserving aqueous and artificial tears on the ocular surface to reduce the signs and symptoms of dry eye. An absorbable plug may be used temporarily to assess the effectiveness of this therapy prior to insertion of a longterm nonabsorbable plug (Freeman-type, Herrick Lacrimal Plug, or SmartPlug) or cautery. Indications and contraindications for use of punctal plugs are discussed, as are features of various plugs, techniques of insertion and removal, complications, and outcomes.