- Email: [email protected]
A New Punctal Plug Insertion Technique to Prevent Intracanalicular Plug Migration
A New Punctal Plug Insertion Technique to Prevent Intracanalicular Plug Migration MINAKO KAIDO, REIKO ISHIDA, MURAT DOGRU, AND KAZUO TSUBOTA ● PURPOSE:
To evaluate the intracanalicular migration rate during plug insertion with a new plug insertion technique compared with a standard technique. ● DESIGN: Interventional, nonrandomized, comparative study. ● METHOD: Forty-five patients with dry eye syndrome underwent a punctal plug insertion with the new technique, and 33 patients underwent a punctal plug insertion with a standard technique at the dry eye subspecialty outpatient clinic of the Department of Ophthalmology at Keio University. Tear function examinations and ocular surface evaluations, including the Schirmer test, tear film breakup time, fluorescein and Rose Bengal vital staining scores, were performed before punctal plug insertion. Super Flex Punctum Plugs (Eagle Vision, Memphis, Tennessee, USA; Softplug-Oasis Medical Inc, Glendora, California, USA) were implanted in all subjects with both techniques. In total, 120 procedures were carried out with the new technique and 132 procedures with the standard technique. ● RESULTS: There were no statistical differences between the two groups in tear function and ocular surface staining scores (P > .05). There was no intracanalicular plug migration with the new insertion technique, whereas there were 18 incidents of intracanalicular migration of 132 standard plug insertion procedures (13.6%). ● CONCLUSIONS: The new plug insertion technique seems to be effective in eliminating intracanalicular plug migration during the insertion procedure. (Am J Ophthalmol 2009;147:178 –182. © 2009 by Elsevier Inc. All rights reserved.)
P
UNCTAL OCCLUSION USING PUNCTAL PLUGS HAS
been recognized as a simple, safe, and effective treatment for dry eye syndromes, preventing tear outflow to the nasolacrimal canal and providing retention of nutritive and healing tear components to the ocular surface. Silicone plugs, which are available in a wide size
Accepted for publication Jul 3, 2008. From the Department of Ophthalmology, Keio University School of Medicine (M.K., R.I., K.T.); and the Johnson & Johnson Ocular Surface Visual Optics Department, Keio University School of Medicine (M.K., M.D.), Tokyo, Japan. Inquiries to Murat Dogru, Johnson & Johnson Ocular Surface and Visual Optics Department, Keio University School of Medicine, Shinanomachi 25, Shinjuku-ku, Tokyo, Japan; e-mail: muratodooru@ yahoo.com
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range to ensure a perfect fit, are used widely for punctal occlusion. Several complications of punctal plugs, such as corneal or conjunctival abrasion by the exposed portion of the plugs, plug extrusion, spontaneous plug loss, acute conjunctivitis associated with biofilm formation on the punctual plug, formation of granuloma, intracanalicular migration, or punctual incarceration, have been reported.1–13 Corneal or conjunctival abrasions are complications that can be treated easily by removing the punctal plugs. Spontaneous plug loss is another important problematic issue associated with punctal plug occlusion. The rate of spontaneous plug loss varies between 20% to 50% in several studies.14 –16 It also has been reported that punctual size is enlarged after extraction of punctal plugs.17 Intracanalicular plug migration at the time of punctal plug insertion is another underrecognized and not well-studied complication, because it is asymptomatic in most cases, unless dacryocystitis as a result of punctual migration occurs.18 A PubMed search revealed that there are still no data available about the incidence of punctual migration during punctal plug insertion. Punctal plug implantation into the lacrimal canaliculus can be troublesome for both patients and surgeons. Herein we present a new punctal plug insertion technique that we believe prevents intracanalicular plug migration during insertion.
METHODS ● SUBJECTS:
Forty-five patients (16 males, 29 females; mean age, 52.7 ⫾ 19.2 years; range, 20 to 91 years) with dry eye syndromes underwent punctal plug insertion with a new technique at the dry eye subspecialty outpatient clinic of the Department of Ophthalmology at Keio University School of Medicine between April 1 and October 31, 2007. Thirty-three patients (11 males, 22 females; mean age, 50.0 ⫾ 16.3 years; range, 21 to 80 years) with dry eye syndrome who underwent punctal plug insertion with a standard technique between September 1 and November 30, 2006 served as controls. This was an interventional, nonrandomized, comparative study of the differences of plug migration rate between these two groups. Patients who were diagnosed with definite or probable dry eyes according to the Japanese dry eye diagnostic criteria and who previously used nonpreserved artificial tear drops for at least one month without improvement of ocular surface findings and dry eye symptom-
ELSEVIER INC. ALL
RIGHTS RESERVED.
0002-9394/09/$36.00 doi:10.1016/j.ajo.2008.07.012
TABLE 1. Number and Percentages of Implantation Region of the Punctum Plugs with the Standard and the New Techniques No. of Insertion Procedures
Implantation region Upper lacrimal puncta Lower lacrimal puncta
Standard Technique (132 Procedures)
New Technique (120 Procedures)
66 (50%) 66 (50%)
60 (50%) 60 (50%)
atology were included in the study. Etiologies for which the patients underwent punctal plug occlusion included Sjögren and non-Sjögren dry eye syndrome, short tear film breakup time (BUT) dry eyes resulting from visual display terminal syndrome, superior limbic keratoconjunctivitis, VIIth nerve palsy, and dry eyes resulting from penetrating keratoplasty. Patients with dacryocystitis, corneal epithelitis resulting from medicamentosa, blepharitis, ocular allergy, patients wearing contact lenses, glaucoma, uveitis, and retinal diseases were excluded. Patients who underwent punctal plug insertion with the new technique underwent the same examinations and same follow-up procedures as the group who received punctal plug insertion with the standard technique. Patient inclusion and exclusion criteria were the same and age and gender matching was carried out during the recruitment of the group that underwent punctal plug insertion with the new technique during 2007. In total, 120 upper and lower plug insertion procedures were performed with a new technique in the current study. One hundred and thirty-two insertion procedures were carried out with the standard technique (Table 1). The patients of both groups were followed up for at least three months. Informed consent was obtained from all subjects after the explanation of both advantages and disadvantages of punctal plug occlusion. ● TEAR FUNCTION AND OCULAR SURFACE EXAMINATIONS: The diagnosis of dry eye was based on the diag-
nostic criteria of the Dry Eye Research group in Japan.19 Patients who underwent punctal plug insertion with the new technique underwent the same tear function and ocular surface examinations as the group who underwent punctal plug insertion with the standard technique. The patients also were asked about subjective visual and dry eye symptoms. The standard tear film BUT measurement was performed after instillation of a 2-l preservative-free volume of 1% fluorescein dye in the conjunctival sac with a micropipette. The patients then were instructed to blink several times for a few seconds to ensure adequate mixing of the dye. The interval between the last complete blink and the appearance of the first corneal black spot in the stained tear film was measured three times and the mean value of the measurements was calculated. A BUT value of five seconds or less was considered abnormal. A cobalt blue VOL. 147, NO. 1
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filter was used to measure the BUT. Fluorescein and Rose Bengal stain scoring of the ocular surface also were performed by the double vital staining method.20 The Rose Bengal and fluorescein staining scores of the ocular surface ranged between 0 and 9 points.21,22 The Van Bijsterveld scoring system was used for Rose Bengal staining. Briefly, the ocular surface was divided into three zones as nasal conjunctival, corneal, and temporal conjunctival areas. A staining score between 0 ⫺3 points was used in each zone, with the minimum and maximum total staining scores ranging between 0 and 9 points. The presence of scarce punctuate staining received 1 point. The presence of denser staining not covering the entire zone received 2 points. The presence of Rose Bengal staining over the entire zone received 3 points. In fluorescein staining, the cornea was divided into three equal upper, middle, and lower zones. Each zone had a staining score ranging between 0 and 3 points, with the minimum and maximum total staining scores ranging between 0 and 9 points. Likewise, presence of scarce staining in one zone was scored as 1 point, whereas punctuate staining covering the entire zone was scored as 3 points. For further evaluation of tears, the standard Schirmer test without topical anesthesia was performed. The standardized strips of filter paper (Alcon Inc, Fort Worth, Texas, USA) were placed in the lateral canthus away from the cornea and were left in place for five minutes with the eyes closed. Readings were reported in millimeters of wetting for five minutes. ● PUNCTAL PLUG CHARACTERISTICS: Super Flex Punctum Plugs (Eagle Vision, Memphis, Tennessee, USA; Softplug-Oasis Medical Inc, Glendora, California, USA) were used in all subjects. This device is available in eight sizes from 0.4 to 1.1 mm on a 0.1-mm scale. The plug, which has a collarette perpendicular to the body of the plug, is attached to the inserter with a built-in needle. The built-in needle is designed with an L shape, the longer portion hooked to the plug inserter body and the shorter portion hooked to the push-button. Pushing the pushbutton of the inserter moves the needle backward. By pushing the push-button of the inserter, the plug body moves toward the apex of the inserter body and is detached for occlusion (Figure 1). ● THE NEW TECHNIQUE OF PUNCTAL PLUG INSERTION: A gauging system of Eagle Vision was used before
punctal plug insertion to determine the plug size. Plugs with a diameter 1 size more than that measured by the gauge were inserted in both groups in this study. All subjects underwent both superior and inferior punctal occlusion in this study. Topical anesthesia was not applied before punctal plug insertion. The punctal plug was set so that the plug connected to the apex of the inserter body without any interspace by moderately pushing the push-button before implantation PUNCTAL PLUG INSERTION
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the inserter body slightly while making sure that the rim of the collarette was sitting on the punctum (Figure 2, Bottom right). Two experienced surgeons (M.K. and R.I.) carried out the lacrimal punctal plug insertions using this new technique in 45 patients. The standard technique without pushing the push-button, which leaves an interspace with the plug and the inserter body, was performed in 33 patients. ● STATISTICAL ANALYSIS:
Tear function and ocular surface staining scores were compared between the subjects receiving punctal plug insertion with the new technique and the standard technique by the Mann–Whitney U test. The differences of intracanalicular migration rate of punctal plugs between the two techniques were studied by the Chi-square test. SPSS software version 12.0J for Windows (SPSS Inc, Chicago, Illinois, USA) was used as the statistical analysis software. A P value of less than .05 was considered to be statistically significant.
FIGURE 1. Structural features of the punctal plug. (Top left) Photograph showing that the punctal plug is connected with the needle set-in the inserter. (Middle left) Photograph showing the disassembled inserter. (Bottom left) Photograph showing the punctal plug coming into contact with the apex of the inserter body. (Top right) Photograph showing that when the pushbutton is pressed, the L-shaped needle slides backward. The punctal plug slides further backward. (Bottom right) Photograph showing that when the push button is pressed more, the punctal plug is detached.
RESULTS ● TEAR FUNCTION AND OCULAR SURFACE EXAMINA-
The mean values of Schirmer test, tear clearance, BUT, and fluorescein and Rose Bengal staining scores in all subjects were 8.3 ⫾ 6.5 mm, 12.2 ⫾ 10.6 times, 2.6 ⫾ 1.6 seconds, 2.6 ⫾ 2.6 points, and 1.4 ⫾ 2.1 points. The detail of the corresponding values in the subjects who underwent punctal plug insertion with the new technique and the subjects who received punctal plug insertion with the standard technique are shown in Table 2. There were no statistical differences between the two groups in the tear function and ocular surface staining scores (P ⬎ .05). TIONS:
● IMPLANTATION REGION OF PUNCTAL PLUGS:
Table 3 shows the detail of plug sizes inserted with both techniques. The plug sizes of 0.6, 0.7, and 0.8 mm commonly were used with both techniques. Plug sizes used with both techniques did not show significant differences (P ⬎ .05).
FIGURE 2. Mechanism of the punctal plug insertion procedure. (Top left and right) Images demonstrating a standard punctal plug insertion procedure. Note that when (Top right) a space is present between the plug and the inserter and when the plug is inserted beyond the lacrimal punctal ring, the ring moves toward the needle, forming a barrier to pull out a deeply inserted plug that predisposes to (Top left) intracanalicular plug migration. (Bottom left and right) A new punctal plug insertion procedure. (Bottom left) Note that when the space between the plug and the inserter body is eliminated by pressing the knob before insertion, the punctal ring rests on the inserter body. (Bottom right) Even when the plug is inserted deeply beneath the punctal ring, the plug can still be pulled up.
● THE RATIO OF INTRACANALICULAR PLUG MIGRATION: Table 4 shows the rate of intracanalicular plug migration. There were no incidents of intracanalicular plug migration with the new insertion technique. In the group undergoing punctal plug insertion with the standard technique, there were 13 incidences of intracanalicular migration of 66 upper punctual plug insertion procedures (19.7%), whereas there were five incidents of intracanalicular migration incidents of 66 lower punctual plug insertion procedures (7.6%). The intracanalicular migration rate into the upper puncta was more than twice as much as the intracanalicular migration rate into the lower
of the plug (Figure 2, Bottom left). Then, the plug was inserted in this state with a gentle push. After inserting the plug into the punctum, the plug was removed by pulling up 180
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TABLE 2. Comparison of Tear Function Parameters and Vital Staining Scores in Patients Receiving Punctum Plug Insertion with the Standard and the New Techniques
Standard technique New technique
Schirmer Test (mm)
Tear Clearance (times)
Tear Film BUT (seconds)
Fluorescein Scores (points)
Rose Bengal Scores (points)
8.6 ⫾ 6.0 7.9 ⫾ 6.0
11.6 ⫾ 10.7 13.0 ⫾ 10.6
2.7 ⫾ 1.7 2.5 ⫾ 1.5
2.5 ⫾ 2.9 2.6 ⫾ 2.3
1.1 ⫾ 1.8 1.8 ⫾ 2.4
BUT ⫽ breakup time.
TABLE 3. Distribution of Plug Sizes Used with the Standard and New Techniques Standard Technique, No. of Procedures (%)
New Technique, No. of Procedures (%)
Plug Size (mm)
Upper Lacrimal Puncta (66 Procedures)
Lower Lacrimal Puncta (66 Procedures)
Upper Lacrimal Puncta (60 Procedures)
Lower Lacrimal Puncta (60 Procedures)
0.4 0.5 0.6 0.7 0.8 0.9 1.0
3 (4.5%) 6 (9.0%) 18 (27.3%) 15 (22.7%) 18 (22.7%) 5 (7.6%) 1 (1.5%)
0 (0%) 6 (9.0%) 13 (19.7%) 22 (33.3%) 15 (22.7%) 10 (15.2%) 0 (0%)
4 (6.7%) 8 (13.3%) 17 (28.3%) 15 (25.0%) 12 (20.0%) 3 (5%) 1 (1.7%)
0 (0%) 9 (15.5%) 18 (30.0%) 15 (25.5%) 10 (16.7%) 7 (11.7%) 1 (1.7%)
DISCUSSION
TABLE 4. Number and Percentages of Intracanalicular Plug Migration Incidents with the Standard and New Techniques
PUNCTAL PLUG INSERTION IS A SIMPLE, EFFECTIVE, AND ES-
Implantation Procedure Standard Technique New Technique
No. of intracanalicular plugs (%) Upper lacrimal puncta Lower lacrimal puncta
13 (19.7%) 5 (7.6%)
0 (0%) 0 (0%)
puncta, although statistical differences could not be shown (P ⬎ .05). Overall, there were 18 incidents of intracanalicular migration of 132 standard plug insertion procedures (13.6%). The intracanalicular plug migration rate was significantly lower with the new insertion technique compared with the standard insertion procedure (P ⬍ .05). Subjects with the standard or new insertion techniques did not have any complications such as granuloma, dacryocystitis, or canaliculitis, except for excessive tearing and spontaneous plug loss. Epiphora was noted in 36.4% of the eyes undergoing punctal plug insertion with the standard technique and 36.7% of the eyes undergoing plug insertion with the new technique (P ⬎ .05). Spontaneous plug loss was observed in 39.4% of the eyes undergoing punctal plug insertion with the standard technique and in 30.0% of the eyes undergoing punctal plug insertion with the new technique. The rate of spontaneous punctal plug loss was not statistically different between the two techniques (P ⬎ .05). VOL. 147, NO. 1
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tablished treatment for dry eye syndromes. Reported complications of punctal plug treatment include rupture of the punctum during dilatation, suppurative canaliculitis, spontaneous loss, epiphora, and intracanalicular plug migration.1–18 In this study, we investigated the intracanalicular plug migration rate with a standard technique and a new technique devised by us that we believed would decrease the plug migration rate during the insertion procedure. Our study revealed an intracanalicular plug migration rate of 13.8% with the standard insertion technique compared with 0% with the new technique. The plug migration rate for the upper punctum insertion procedures was twice as frequent compared with the lower punctum insertion procedures. We believe that this difference in plug migration rate for the upper punctum insertion procedures with the standard technique results from the difficulty of the plug insertion into the upper puncta compared with the lower punctum insertions. The difficulties in maneuvering the wrist and the fingers during an upper punctual insertion procedure may result in unavoidable application of excessive pressure to the inserter knob, resulting in plug migration when the standard technique is used. Although the insertion procedure in upper puncta is equally difficult when the new technique is used, we did not observe any intracanalicular plug migrations. It is our experience that the new technique eliminates application of excessive pressure to the inserter and aids plug insertion in a more controlled fashion. PUNCTAL PLUG INSERTION
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Recently, Yokoi and associates reported a new plug injector in which the plug is placed on the inserter needle. The plug can be pushed forward and pulled back by a rolling knob adjuster. The plug is inserted when it is sitting on the inserter body. Yokoi and associates also reported not having experienced any intracanalicular migration incidents with this new inserter (Nishii M, Yokoi N, Komuro A, Kinoshita S. The Development of a Punctal Plug Inserter which Definitely Prevents Intracanalicular Plug Migration. Presented at the 60th Congress of Clinical Ophthalmology of Japan, Tokyo, Japan, unpublished data, 2006). Based on our observations from this study, we devised a new technique with the Super Flex plug inserter of pushing the knob until the plug sat on the inserter body, a setting that simulated the inserter procedure with the inserter of Yokoi.
It is our belief that when a space is present between the plug and the inserter, as shown in Figure 2 (Top), and when the plug is inserted beyond the lacrimal punctal ring, the ring moves toward the needle, forming a barrier to pull out a deeply inserted plug that predisposes the plug to intracanalicular plug migration. However, when the space between the plug and the inserter body is eliminated by pressing the knob before insertion, the punctal ring rests on the inserter body. Even when the plug is inserted deeply beneath the punctal ring, the plug still can be pulled up (Figure 2, Bottom). In summary, we reported a new technique of plug insertion that we believe decreases the intracanalicular plug migration rate. It should be remembered that the intracanalicular plug migration rate reported in this study is solely for the Super Flex Punctum Plug and that comparative future studies for other plugs will provide interesting information.
THE AUTHORS INDICATE NO FINANCIAL SUPPORT OR FINANCIAL CONFLICT OF INTEREST. INVOLVED IN DESIGN AND conduct of study (M.K., R.I., M.D., K.T.); data collection and analysis (M.K., R.I.); and preparation (M.K., R.I., M.D.) and review and approval (M.K, M.D.) of the manuscript. Examination procedures were board reviewed at Keio University, School of Medicine. The study followed the Tenets of the Declaration of Helsinki. Informed consent was obtained from all subjects after the explanation of both advantages and disadvantages of punctal plug occlusion.
12. Akova YA, Demirhan B, Cakmakci S, Aydin P. Pyogenic granuloma: a rare complication of silicone punctual plugs. Ophthalmic Surg Lasers 1999;30:584 –585. 13. Pastor-Pascual F, Avino-Martinez J, Espana-Gregori E, Alcocer-Yuste P. Pyogenic granuloma following SmartPlug insertion. Arch Socr Esp Oftalmol 2007;82:653– 655. 14. Piccone MR. A new technique for retrieval or repositioning of damage or migrated silicone punctual plugs. Ophthalmic Surg Lasers 2000;31:351–352. 15. Rumelt S, Remulla H, Rubin PA. Silicone punctual plug migration resulting in dacryocystitis and canaliculitis. Cornea 1997;16:377–379. 16. Nishii M, Yokoi N, Komuro A, Kinoshita S. Clinical investigation of extrusion of a new punctual plug (Flex Plug). Nippon Ganka Gakkai Zasshi 2004;108:139 –143. 17. Inagaki K, Yokoi N, Nishii M, Komuro A, Kinoshita S. Study of change of size of the punctum before insertion and after extraction of a punctal plug and selection of an appropriate plug for reinsertion. Nippon Ganka Gakkai Zasshi 2005;109: 274 –278. 18. Fayet B, Assouline M, Hanush S, Bernard JA, D’Hermies F, Renard G. Silicone punctual plug extrusion resulting from spontaneous dissection of canalicular mucosa. A clinical and histopathologic report. Ophthalmology 2001; 108:405– 409. 19. Shimazaki J. Definition and criteria of dry eye [in Japanese]. Ganka 1995;37:765–770. 20. Toda I, Tsubota K. Practical double vital staining for ocular surface evaluation. Cornea 1993;12:366 –367. 21. Van Bijsterveld OP. Diagnostic tests in the Sicca syndrome. Arch Ophthalmol 1969;82:10 –14. 22. Tsubota K, Dogru M. Changing perspectivesfor the treatment of dry eye. Contemporary Ophthalmology 2002;1:1– 8.
REFERENCES 1. Fayet B, Bernard JA, Ammar J, et al. Complications des bouchons lacrymaux employes dans le traitement symptomatique des secheresses oculaires. J Fr Ophthalmol 1990;13: 135–142. 2. Levenson JE, Hofbaver J. Problems with punctal plugs. Case report. Arch Ophthalmol 1989;107:493– 494. 3. Nelson CC. Complications of Freeman plugs [letter]. Arch Ophthalmol 1991;109:923–924. 4. Maguire LJ, Bartley GB. Complications associated with the new smaller size Freeman punctual plug. Case report. Arch Ophthalmol 1989;107:961–962. 5. Fayet B, Koster H, Benabderrazik S, Bernard JA, Pouliquen Y. Six canalicular stenoses after 34 punctal plugs. Eur J Ophthalmol 1991;1:154 –155. 6. Yokoi N, Okada K, Sugita J, Kinoshita S. Acute conjunctivitis associated with biofilm formation on punctal plug. Jpn J Ophthalmol 2000;44:559 –560. 7. Sugita J, Yokoi N, Fullwood NJ, et al. The detection of bacteria and biofilms in punctal plug holes. Cornea 2001;20: 362–365. 8. Rapoza PA, Ruddat MS. Pyogenic granuloma as a complication of silicone punctual plugs [letter]. Am J Ophthalmol 1992;113:454 – 455. 9. SmartPlug Study Group. Management of complications after insertion of the SmartPlug punctual plug: a study of 28 patients. Ophthalmology 2006;113:1859 10. Kim BM, Osmanovic SS, Edward DP. Pyogenic granuloma after silicon punctual plugs: a clinical and histopathologic study. Am J Ophthalmol 2005;139:678 – 688. 11. Hsu HC. Ampullary pyogenic granuloma as a complication of lacrimal plug migration. Chang Gung Med J 2002;25:415– 418.
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Biosketch Dr Minako Kaido graduated from the Medical University of Occupational and Environmental Health, Fukuoka, Japan in 1991. She joined Dr Tsubota’s dry eye and cornea team in Tokyo Dental College Ichikawa Hospital in 1995 and still a pivotal member of Dr Tsubota’s team at Keio University School of Medicine, Tokyo, Japan since 2004. Dr Kaido’s work is focused on the treatment of dry eyes especially associated with Stevens-Johnson syndrome, functional visual acuity technology, and suture adjustment after keratoplasty.
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182.e1
To evaluate the intracanalicular migration rate during plug insertion with a new plug insertion technique compared with a standard technique. ● DESIGN: Interventional, nonrandomized, comparative study. ● METHOD: Forty-five patients with dry eye syndrome underwent a punctal plug insertion with the new technique, and 33 patients underwent a punctal plug insertion with a standard technique at the dry eye subspecialty outpatient clinic of the Department of Ophthalmology at Keio University. Tear function examinations and ocular surface evaluations, including the Schirmer test, tear film breakup time, fluorescein and Rose Bengal vital staining scores, were performed before punctal plug insertion. Super Flex Punctum Plugs (Eagle Vision, Memphis, Tennessee, USA; Softplug-Oasis Medical Inc, Glendora, California, USA) were implanted in all subjects with both techniques. In total, 120 procedures were carried out with the new technique and 132 procedures with the standard technique. ● RESULTS: There were no statistical differences between the two groups in tear function and ocular surface staining scores (P > .05). There was no intracanalicular plug migration with the new insertion technique, whereas there were 18 incidents of intracanalicular migration of 132 standard plug insertion procedures (13.6%). ● CONCLUSIONS: The new plug insertion technique seems to be effective in eliminating intracanalicular plug migration during the insertion procedure. (Am J Ophthalmol 2009;147:178 –182. © 2009 by Elsevier Inc. All rights reserved.)
P
UNCTAL OCCLUSION USING PUNCTAL PLUGS HAS
been recognized as a simple, safe, and effective treatment for dry eye syndromes, preventing tear outflow to the nasolacrimal canal and providing retention of nutritive and healing tear components to the ocular surface. Silicone plugs, which are available in a wide size
Accepted for publication Jul 3, 2008. From the Department of Ophthalmology, Keio University School of Medicine (M.K., R.I., K.T.); and the Johnson & Johnson Ocular Surface Visual Optics Department, Keio University School of Medicine (M.K., M.D.), Tokyo, Japan. Inquiries to Murat Dogru, Johnson & Johnson Ocular Surface and Visual Optics Department, Keio University School of Medicine, Shinanomachi 25, Shinjuku-ku, Tokyo, Japan; e-mail: muratodooru@ yahoo.com
178
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2009 BY
range to ensure a perfect fit, are used widely for punctal occlusion. Several complications of punctal plugs, such as corneal or conjunctival abrasion by the exposed portion of the plugs, plug extrusion, spontaneous plug loss, acute conjunctivitis associated with biofilm formation on the punctual plug, formation of granuloma, intracanalicular migration, or punctual incarceration, have been reported.1–13 Corneal or conjunctival abrasions are complications that can be treated easily by removing the punctal plugs. Spontaneous plug loss is another important problematic issue associated with punctal plug occlusion. The rate of spontaneous plug loss varies between 20% to 50% in several studies.14 –16 It also has been reported that punctual size is enlarged after extraction of punctal plugs.17 Intracanalicular plug migration at the time of punctal plug insertion is another underrecognized and not well-studied complication, because it is asymptomatic in most cases, unless dacryocystitis as a result of punctual migration occurs.18 A PubMed search revealed that there are still no data available about the incidence of punctual migration during punctal plug insertion. Punctal plug implantation into the lacrimal canaliculus can be troublesome for both patients and surgeons. Herein we present a new punctal plug insertion technique that we believe prevents intracanalicular plug migration during insertion.
METHODS ● SUBJECTS:
Forty-five patients (16 males, 29 females; mean age, 52.7 ⫾ 19.2 years; range, 20 to 91 years) with dry eye syndromes underwent punctal plug insertion with a new technique at the dry eye subspecialty outpatient clinic of the Department of Ophthalmology at Keio University School of Medicine between April 1 and October 31, 2007. Thirty-three patients (11 males, 22 females; mean age, 50.0 ⫾ 16.3 years; range, 21 to 80 years) with dry eye syndrome who underwent punctal plug insertion with a standard technique between September 1 and November 30, 2006 served as controls. This was an interventional, nonrandomized, comparative study of the differences of plug migration rate between these two groups. Patients who were diagnosed with definite or probable dry eyes according to the Japanese dry eye diagnostic criteria and who previously used nonpreserved artificial tear drops for at least one month without improvement of ocular surface findings and dry eye symptom-
ELSEVIER INC. ALL
RIGHTS RESERVED.
0002-9394/09/$36.00 doi:10.1016/j.ajo.2008.07.012
TABLE 1. Number and Percentages of Implantation Region of the Punctum Plugs with the Standard and the New Techniques No. of Insertion Procedures
Implantation region Upper lacrimal puncta Lower lacrimal puncta
Standard Technique (132 Procedures)
New Technique (120 Procedures)
66 (50%) 66 (50%)
60 (50%) 60 (50%)
atology were included in the study. Etiologies for which the patients underwent punctal plug occlusion included Sjögren and non-Sjögren dry eye syndrome, short tear film breakup time (BUT) dry eyes resulting from visual display terminal syndrome, superior limbic keratoconjunctivitis, VIIth nerve palsy, and dry eyes resulting from penetrating keratoplasty. Patients with dacryocystitis, corneal epithelitis resulting from medicamentosa, blepharitis, ocular allergy, patients wearing contact lenses, glaucoma, uveitis, and retinal diseases were excluded. Patients who underwent punctal plug insertion with the new technique underwent the same examinations and same follow-up procedures as the group who received punctal plug insertion with the standard technique. Patient inclusion and exclusion criteria were the same and age and gender matching was carried out during the recruitment of the group that underwent punctal plug insertion with the new technique during 2007. In total, 120 upper and lower plug insertion procedures were performed with a new technique in the current study. One hundred and thirty-two insertion procedures were carried out with the standard technique (Table 1). The patients of both groups were followed up for at least three months. Informed consent was obtained from all subjects after the explanation of both advantages and disadvantages of punctal plug occlusion. ● TEAR FUNCTION AND OCULAR SURFACE EXAMINATIONS: The diagnosis of dry eye was based on the diag-
nostic criteria of the Dry Eye Research group in Japan.19 Patients who underwent punctal plug insertion with the new technique underwent the same tear function and ocular surface examinations as the group who underwent punctal plug insertion with the standard technique. The patients also were asked about subjective visual and dry eye symptoms. The standard tear film BUT measurement was performed after instillation of a 2-l preservative-free volume of 1% fluorescein dye in the conjunctival sac with a micropipette. The patients then were instructed to blink several times for a few seconds to ensure adequate mixing of the dye. The interval between the last complete blink and the appearance of the first corneal black spot in the stained tear film was measured three times and the mean value of the measurements was calculated. A BUT value of five seconds or less was considered abnormal. A cobalt blue VOL. 147, NO. 1
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filter was used to measure the BUT. Fluorescein and Rose Bengal stain scoring of the ocular surface also were performed by the double vital staining method.20 The Rose Bengal and fluorescein staining scores of the ocular surface ranged between 0 and 9 points.21,22 The Van Bijsterveld scoring system was used for Rose Bengal staining. Briefly, the ocular surface was divided into three zones as nasal conjunctival, corneal, and temporal conjunctival areas. A staining score between 0 ⫺3 points was used in each zone, with the minimum and maximum total staining scores ranging between 0 and 9 points. The presence of scarce punctuate staining received 1 point. The presence of denser staining not covering the entire zone received 2 points. The presence of Rose Bengal staining over the entire zone received 3 points. In fluorescein staining, the cornea was divided into three equal upper, middle, and lower zones. Each zone had a staining score ranging between 0 and 3 points, with the minimum and maximum total staining scores ranging between 0 and 9 points. Likewise, presence of scarce staining in one zone was scored as 1 point, whereas punctuate staining covering the entire zone was scored as 3 points. For further evaluation of tears, the standard Schirmer test without topical anesthesia was performed. The standardized strips of filter paper (Alcon Inc, Fort Worth, Texas, USA) were placed in the lateral canthus away from the cornea and were left in place for five minutes with the eyes closed. Readings were reported in millimeters of wetting for five minutes. ● PUNCTAL PLUG CHARACTERISTICS: Super Flex Punctum Plugs (Eagle Vision, Memphis, Tennessee, USA; Softplug-Oasis Medical Inc, Glendora, California, USA) were used in all subjects. This device is available in eight sizes from 0.4 to 1.1 mm on a 0.1-mm scale. The plug, which has a collarette perpendicular to the body of the plug, is attached to the inserter with a built-in needle. The built-in needle is designed with an L shape, the longer portion hooked to the plug inserter body and the shorter portion hooked to the push-button. Pushing the pushbutton of the inserter moves the needle backward. By pushing the push-button of the inserter, the plug body moves toward the apex of the inserter body and is detached for occlusion (Figure 1). ● THE NEW TECHNIQUE OF PUNCTAL PLUG INSERTION: A gauging system of Eagle Vision was used before
punctal plug insertion to determine the plug size. Plugs with a diameter 1 size more than that measured by the gauge were inserted in both groups in this study. All subjects underwent both superior and inferior punctal occlusion in this study. Topical anesthesia was not applied before punctal plug insertion. The punctal plug was set so that the plug connected to the apex of the inserter body without any interspace by moderately pushing the push-button before implantation PUNCTAL PLUG INSERTION
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the inserter body slightly while making sure that the rim of the collarette was sitting on the punctum (Figure 2, Bottom right). Two experienced surgeons (M.K. and R.I.) carried out the lacrimal punctal plug insertions using this new technique in 45 patients. The standard technique without pushing the push-button, which leaves an interspace with the plug and the inserter body, was performed in 33 patients. ● STATISTICAL ANALYSIS:
Tear function and ocular surface staining scores were compared between the subjects receiving punctal plug insertion with the new technique and the standard technique by the Mann–Whitney U test. The differences of intracanalicular migration rate of punctal plugs between the two techniques were studied by the Chi-square test. SPSS software version 12.0J for Windows (SPSS Inc, Chicago, Illinois, USA) was used as the statistical analysis software. A P value of less than .05 was considered to be statistically significant.
FIGURE 1. Structural features of the punctal plug. (Top left) Photograph showing that the punctal plug is connected with the needle set-in the inserter. (Middle left) Photograph showing the disassembled inserter. (Bottom left) Photograph showing the punctal plug coming into contact with the apex of the inserter body. (Top right) Photograph showing that when the pushbutton is pressed, the L-shaped needle slides backward. The punctal plug slides further backward. (Bottom right) Photograph showing that when the push button is pressed more, the punctal plug is detached.
RESULTS ● TEAR FUNCTION AND OCULAR SURFACE EXAMINA-
The mean values of Schirmer test, tear clearance, BUT, and fluorescein and Rose Bengal staining scores in all subjects were 8.3 ⫾ 6.5 mm, 12.2 ⫾ 10.6 times, 2.6 ⫾ 1.6 seconds, 2.6 ⫾ 2.6 points, and 1.4 ⫾ 2.1 points. The detail of the corresponding values in the subjects who underwent punctal plug insertion with the new technique and the subjects who received punctal plug insertion with the standard technique are shown in Table 2. There were no statistical differences between the two groups in the tear function and ocular surface staining scores (P ⬎ .05). TIONS:
● IMPLANTATION REGION OF PUNCTAL PLUGS:
Table 3 shows the detail of plug sizes inserted with both techniques. The plug sizes of 0.6, 0.7, and 0.8 mm commonly were used with both techniques. Plug sizes used with both techniques did not show significant differences (P ⬎ .05).
FIGURE 2. Mechanism of the punctal plug insertion procedure. (Top left and right) Images demonstrating a standard punctal plug insertion procedure. Note that when (Top right) a space is present between the plug and the inserter and when the plug is inserted beyond the lacrimal punctal ring, the ring moves toward the needle, forming a barrier to pull out a deeply inserted plug that predisposes to (Top left) intracanalicular plug migration. (Bottom left and right) A new punctal plug insertion procedure. (Bottom left) Note that when the space between the plug and the inserter body is eliminated by pressing the knob before insertion, the punctal ring rests on the inserter body. (Bottom right) Even when the plug is inserted deeply beneath the punctal ring, the plug can still be pulled up.
● THE RATIO OF INTRACANALICULAR PLUG MIGRATION: Table 4 shows the rate of intracanalicular plug migration. There were no incidents of intracanalicular plug migration with the new insertion technique. In the group undergoing punctal plug insertion with the standard technique, there were 13 incidences of intracanalicular migration of 66 upper punctual plug insertion procedures (19.7%), whereas there were five incidents of intracanalicular migration incidents of 66 lower punctual plug insertion procedures (7.6%). The intracanalicular migration rate into the upper puncta was more than twice as much as the intracanalicular migration rate into the lower
of the plug (Figure 2, Bottom left). Then, the plug was inserted in this state with a gentle push. After inserting the plug into the punctum, the plug was removed by pulling up 180
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TABLE 2. Comparison of Tear Function Parameters and Vital Staining Scores in Patients Receiving Punctum Plug Insertion with the Standard and the New Techniques
Standard technique New technique
Schirmer Test (mm)
Tear Clearance (times)
Tear Film BUT (seconds)
Fluorescein Scores (points)
Rose Bengal Scores (points)
8.6 ⫾ 6.0 7.9 ⫾ 6.0
11.6 ⫾ 10.7 13.0 ⫾ 10.6
2.7 ⫾ 1.7 2.5 ⫾ 1.5
2.5 ⫾ 2.9 2.6 ⫾ 2.3
1.1 ⫾ 1.8 1.8 ⫾ 2.4
BUT ⫽ breakup time.
TABLE 3. Distribution of Plug Sizes Used with the Standard and New Techniques Standard Technique, No. of Procedures (%)
New Technique, No. of Procedures (%)
Plug Size (mm)
Upper Lacrimal Puncta (66 Procedures)
Lower Lacrimal Puncta (66 Procedures)
Upper Lacrimal Puncta (60 Procedures)
Lower Lacrimal Puncta (60 Procedures)
0.4 0.5 0.6 0.7 0.8 0.9 1.0
3 (4.5%) 6 (9.0%) 18 (27.3%) 15 (22.7%) 18 (22.7%) 5 (7.6%) 1 (1.5%)
0 (0%) 6 (9.0%) 13 (19.7%) 22 (33.3%) 15 (22.7%) 10 (15.2%) 0 (0%)
4 (6.7%) 8 (13.3%) 17 (28.3%) 15 (25.0%) 12 (20.0%) 3 (5%) 1 (1.7%)
0 (0%) 9 (15.5%) 18 (30.0%) 15 (25.5%) 10 (16.7%) 7 (11.7%) 1 (1.7%)
DISCUSSION
TABLE 4. Number and Percentages of Intracanalicular Plug Migration Incidents with the Standard and New Techniques
PUNCTAL PLUG INSERTION IS A SIMPLE, EFFECTIVE, AND ES-
Implantation Procedure Standard Technique New Technique
No. of intracanalicular plugs (%) Upper lacrimal puncta Lower lacrimal puncta
13 (19.7%) 5 (7.6%)
0 (0%) 0 (0%)
puncta, although statistical differences could not be shown (P ⬎ .05). Overall, there were 18 incidents of intracanalicular migration of 132 standard plug insertion procedures (13.6%). The intracanalicular plug migration rate was significantly lower with the new insertion technique compared with the standard insertion procedure (P ⬍ .05). Subjects with the standard or new insertion techniques did not have any complications such as granuloma, dacryocystitis, or canaliculitis, except for excessive tearing and spontaneous plug loss. Epiphora was noted in 36.4% of the eyes undergoing punctal plug insertion with the standard technique and 36.7% of the eyes undergoing plug insertion with the new technique (P ⬎ .05). Spontaneous plug loss was observed in 39.4% of the eyes undergoing punctal plug insertion with the standard technique and in 30.0% of the eyes undergoing punctal plug insertion with the new technique. The rate of spontaneous punctal plug loss was not statistically different between the two techniques (P ⬎ .05). VOL. 147, NO. 1
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tablished treatment for dry eye syndromes. Reported complications of punctal plug treatment include rupture of the punctum during dilatation, suppurative canaliculitis, spontaneous loss, epiphora, and intracanalicular plug migration.1–18 In this study, we investigated the intracanalicular plug migration rate with a standard technique and a new technique devised by us that we believed would decrease the plug migration rate during the insertion procedure. Our study revealed an intracanalicular plug migration rate of 13.8% with the standard insertion technique compared with 0% with the new technique. The plug migration rate for the upper punctum insertion procedures was twice as frequent compared with the lower punctum insertion procedures. We believe that this difference in plug migration rate for the upper punctum insertion procedures with the standard technique results from the difficulty of the plug insertion into the upper puncta compared with the lower punctum insertions. The difficulties in maneuvering the wrist and the fingers during an upper punctual insertion procedure may result in unavoidable application of excessive pressure to the inserter knob, resulting in plug migration when the standard technique is used. Although the insertion procedure in upper puncta is equally difficult when the new technique is used, we did not observe any intracanalicular plug migrations. It is our experience that the new technique eliminates application of excessive pressure to the inserter and aids plug insertion in a more controlled fashion. PUNCTAL PLUG INSERTION
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Recently, Yokoi and associates reported a new plug injector in which the plug is placed on the inserter needle. The plug can be pushed forward and pulled back by a rolling knob adjuster. The plug is inserted when it is sitting on the inserter body. Yokoi and associates also reported not having experienced any intracanalicular migration incidents with this new inserter (Nishii M, Yokoi N, Komuro A, Kinoshita S. The Development of a Punctal Plug Inserter which Definitely Prevents Intracanalicular Plug Migration. Presented at the 60th Congress of Clinical Ophthalmology of Japan, Tokyo, Japan, unpublished data, 2006). Based on our observations from this study, we devised a new technique with the Super Flex plug inserter of pushing the knob until the plug sat on the inserter body, a setting that simulated the inserter procedure with the inserter of Yokoi.
It is our belief that when a space is present between the plug and the inserter, as shown in Figure 2 (Top), and when the plug is inserted beyond the lacrimal punctal ring, the ring moves toward the needle, forming a barrier to pull out a deeply inserted plug that predisposes the plug to intracanalicular plug migration. However, when the space between the plug and the inserter body is eliminated by pressing the knob before insertion, the punctal ring rests on the inserter body. Even when the plug is inserted deeply beneath the punctal ring, the plug still can be pulled up (Figure 2, Bottom). In summary, we reported a new technique of plug insertion that we believe decreases the intracanalicular plug migration rate. It should be remembered that the intracanalicular plug migration rate reported in this study is solely for the Super Flex Punctum Plug and that comparative future studies for other plugs will provide interesting information.
THE AUTHORS INDICATE NO FINANCIAL SUPPORT OR FINANCIAL CONFLICT OF INTEREST. INVOLVED IN DESIGN AND conduct of study (M.K., R.I., M.D., K.T.); data collection and analysis (M.K., R.I.); and preparation (M.K., R.I., M.D.) and review and approval (M.K, M.D.) of the manuscript. Examination procedures were board reviewed at Keio University, School of Medicine. The study followed the Tenets of the Declaration of Helsinki. Informed consent was obtained from all subjects after the explanation of both advantages and disadvantages of punctal plug occlusion.
12. Akova YA, Demirhan B, Cakmakci S, Aydin P. Pyogenic granuloma: a rare complication of silicone punctual plugs. Ophthalmic Surg Lasers 1999;30:584 –585. 13. Pastor-Pascual F, Avino-Martinez J, Espana-Gregori E, Alcocer-Yuste P. Pyogenic granuloma following SmartPlug insertion. Arch Socr Esp Oftalmol 2007;82:653– 655. 14. Piccone MR. A new technique for retrieval or repositioning of damage or migrated silicone punctual plugs. Ophthalmic Surg Lasers 2000;31:351–352. 15. Rumelt S, Remulla H, Rubin PA. Silicone punctual plug migration resulting in dacryocystitis and canaliculitis. Cornea 1997;16:377–379. 16. Nishii M, Yokoi N, Komuro A, Kinoshita S. Clinical investigation of extrusion of a new punctual plug (Flex Plug). Nippon Ganka Gakkai Zasshi 2004;108:139 –143. 17. Inagaki K, Yokoi N, Nishii M, Komuro A, Kinoshita S. Study of change of size of the punctum before insertion and after extraction of a punctal plug and selection of an appropriate plug for reinsertion. Nippon Ganka Gakkai Zasshi 2005;109: 274 –278. 18. Fayet B, Assouline M, Hanush S, Bernard JA, D’Hermies F, Renard G. Silicone punctual plug extrusion resulting from spontaneous dissection of canalicular mucosa. A clinical and histopathologic report. Ophthalmology 2001; 108:405– 409. 19. Shimazaki J. Definition and criteria of dry eye [in Japanese]. Ganka 1995;37:765–770. 20. Toda I, Tsubota K. Practical double vital staining for ocular surface evaluation. Cornea 1993;12:366 –367. 21. Van Bijsterveld OP. Diagnostic tests in the Sicca syndrome. Arch Ophthalmol 1969;82:10 –14. 22. Tsubota K, Dogru M. Changing perspectivesfor the treatment of dry eye. Contemporary Ophthalmology 2002;1:1– 8.
REFERENCES 1. Fayet B, Bernard JA, Ammar J, et al. Complications des bouchons lacrymaux employes dans le traitement symptomatique des secheresses oculaires. J Fr Ophthalmol 1990;13: 135–142. 2. Levenson JE, Hofbaver J. Problems with punctal plugs. Case report. Arch Ophthalmol 1989;107:493– 494. 3. Nelson CC. Complications of Freeman plugs [letter]. Arch Ophthalmol 1991;109:923–924. 4. Maguire LJ, Bartley GB. Complications associated with the new smaller size Freeman punctual plug. Case report. Arch Ophthalmol 1989;107:961–962. 5. Fayet B, Koster H, Benabderrazik S, Bernard JA, Pouliquen Y. Six canalicular stenoses after 34 punctal plugs. Eur J Ophthalmol 1991;1:154 –155. 6. Yokoi N, Okada K, Sugita J, Kinoshita S. Acute conjunctivitis associated with biofilm formation on punctal plug. Jpn J Ophthalmol 2000;44:559 –560. 7. Sugita J, Yokoi N, Fullwood NJ, et al. The detection of bacteria and biofilms in punctal plug holes. Cornea 2001;20: 362–365. 8. Rapoza PA, Ruddat MS. Pyogenic granuloma as a complication of silicone punctual plugs [letter]. Am J Ophthalmol 1992;113:454 – 455. 9. SmartPlug Study Group. Management of complications after insertion of the SmartPlug punctual plug: a study of 28 patients. Ophthalmology 2006;113:1859 10. Kim BM, Osmanovic SS, Edward DP. Pyogenic granuloma after silicon punctual plugs: a clinical and histopathologic study. Am J Ophthalmol 2005;139:678 – 688. 11. Hsu HC. Ampullary pyogenic granuloma as a complication of lacrimal plug migration. Chang Gung Med J 2002;25:415– 418.
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Biosketch Dr Minako Kaido graduated from the Medical University of Occupational and Environmental Health, Fukuoka, Japan in 1991. She joined Dr Tsubota’s dry eye and cornea team in Tokyo Dental College Ichikawa Hospital in 1995 and still a pivotal member of Dr Tsubota’s team at Keio University School of Medicine, Tokyo, Japan since 2004. Dr Kaido’s work is focused on the treatment of dry eyes especially associated with Stevens-Johnson syndrome, functional visual acuity technology, and suture adjustment after keratoplasty.
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