- Email: [email protected]
Early loss of monocanalicular silicone tubes in congenital nasolacrimal duct obstruction: Incidence, predictors, and effect on outcome
International Journal of Pediatric Otorhinolaryngology 79 (2015) 301–304
Contents lists available at ScienceDirect
International Journal of Pediatric Otorhinolaryngology journal homepage: www.elsevier.com/locate/ijporl
Early loss of monocanalicular silicone tubes in congenital nasolacrimal duct obstruction: Incidence, predictors, and effect on outcome Gad Dotan a,b,*, Oded Ohana a, Igal Leibovitch a, Chaim Stolovitch a a b
Department of Ophthalmology, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel Maccabi Healthcare Services, Ramat Hasharon, Israel
A R T I C L E I N F O
A B S T R A C T
Article history: Received 11 May 2014 Received in revised form 22 September 2014 Accepted 25 September 2014 Available online 5 October 2014
Purpose: To study predictors and implications on outcome of premature silicone tube-loss, a postoperative complication of monocanalicular intubation (MCI) performed for treatment of congenital nasolacrimal duct obstruction (CNLDO). Methods: We conducted a retrospective analysis of cases of post-operative loss of monocanalicular silicone tubes occurring at one medical center from January 2007 to December 2013. Results: During the study period monocanclicular silicone tubes were lost in 24/54 eyes (44%) of 19/46 children. Multivariate regression analysis identified bilateral intubation as an important predictor of early tube-loss (r = 0.54, P = 0.006). Seven of eight (88%) children who had both eyes intubated prematurely lost their tubes compared to 12/38 (32%) children who had unilateral intubation (P = 0.005). Treatment success was lower in eyes with early tube-loss (17/24 eyes, 71%) compared to eyes with full tube retention (25/30 eyes, 83%), however this difference was not statistically significant (P = 0.333). In our study, treatment outcome correlated with duration of intubation (r = 0.51, P = 0.002). Surgical success was achieved in 33/39 eyes (85%) in which the tubes were retained at least 2 months compared to 7/15 eyes (47%) with shorter period of intubation (P = 0.012). Conclusions: Spontaneous tube-loss is a post-operative complication of monocanalicular silicone intubation that can occur more frequently than previously reported in certain populations. Tube-loss occurring soon after surgery is often associated with persistent symptoms and increased need of reoperation. ß 2014 Elsevier Ireland Ltd. All rights reserved.
Keywords: Congenital nasolacrimal duct obstruction Monocanalicular silicone tube intubation
1. Introduction Silicone tube intubation of the nasolacrimal duct is a frequently performed procedure for treatment of congenital nasolacrimal duct obstruction (CNLDO) [1–4]. The procedure can be performed in a monocanalicular fashion, through either the upper or lower canaliculus, or in a bicanalicular fashion through both [1–3,5]. The added benefit of the silicone tube that maintains patency of the nasolacrimal duct during the healing process following intubation improves cure rate compared to conventional probing alone [6,7]. Since its introduction in the early 1990s, monocanalicular intubation (MCI) has gained increasing popularity; its numerous advantages which include a shorter procedure time, a single pass
* Corresponding author at: Department of Ophthalmology, Tel Aviv Medical Center, 6 Weizmann Street, Tel Aviv 64239, Israel. Tel.: +972 3 6925773; fax: +972 3 6925693. E-mail address: [email protected] (G. Dotan). http://dx.doi.org/10.1016/j.ijporl.2014.09.027 0165-5876/ß 2014 Elsevier Ireland Ltd. All rights reserved.
through just one canaliculus avoiding the risk of iatrogenic damage to the unprobed canaliculus, and an easier removal, usually performed in the office, appeal to many surgeons [3,7]. However, easier tube retrieval also means increased risk of premature tubeloss and possible self-removal by the child [7]. Although this is a recognized complication of MCI, predictors of its occurrence have not been well studied and controversy remains regarding its effect on outcome. This study analyzed cases of early tube-loss following MCI in order to better understand this postoperative complication. 2. Methods The Institutional Review Board of the Tel Aviv Medical Center approved this study of children who underwent MCI for treatment of CNLDO from January 2007 to December 2013 (study # TLV0455-14) and its performance was in accordance with its rules and regulations. This study was exempt from informed consent because of its retrospective design and minimal risk involved with its design.
302
G. Dotan et al. / International Journal of Pediatric Otorhinolaryngology 79 (2015) 301–304
All children had MCI, which was typically performed when primary CNLDO treatment was done at an older age (>2 years) or following a previously failed probing procedure. Children were identified through a computerized search of the hospital’s database. All children had an established diagnosis of CNLDO based on presence of epiphora, increased tear lake, or mucopurulent discharge without ocular irritation or upper respiratory tract infection beginning before the age of 6 months. Children with Down’s syndrome, craniofacial abnormalities, and eyelid or punctum anomalies were excluded from the study. All procedures were performed under general anesthesia with endotracheal intubation. Probing was universally performed before monocanalicular silicone intubation. Either the Ritleng Monoka or the Monoka-Crawford tubes (FCI ltd., Paris, France) were used in all cases. Following insertion of the silicone tube into the nasolacrimal duct through the lower punctum it was retrieved in the nasal cavity with a Ritleng or Crawford hook and was pulled out from the nose. The excess silicone protruding from the nostril was trimmed, and the punctal plug was secured in the lower eyelid. At the completion of the procedure an antibiotic-steroid drop was applied to the operated eye and was continued three times daily for two weeks. Intended duration of intubation was between 4 and 6 months, and all tubes were supposed to be removed in the office while the child is awake by grasping and removing the punctal plug with forceps. Treatment outcome was determined one month following tube removal and a successful outcome was considered when there was complete resolution of all preoperative CNLDO symptoms and signs. Children were reported as having premature tube-loss if the tube was found missing on a routine follow-up visit less than 4 months from surgery or the family of the child became aware of a missing tube. Duration of intubation in cases of early tube displacement was calculated from the day of insertion to the last follow-up visit in which the tube was seen in place or to the date the family noticed the tube was missing. Statistical analysis was performed using Prism 6 statistical software (GraphPad Software Inc., San Diego, CA). Descriptive statistics is provided. Statistical significance was set at an alpha level of 5% and all statistical tests performed were two-tailed. Unpaired t-test was used for analysis of age and duration of intubation of children who had early tube-loss compared to children whose tubes were removed in the office as planned. Fisher’s exact test was used for analysis of categorical variables, including sex, laterality of CNLDO, type of monocanlicular tube used, and type of intervention (first vs. repeat procedures). A multivariate regression analysis was calculated for factors associated with premature tube-loss and surgical success.
3. Results During the study period MCI was performed in 54 eyes of 46 children with CNLDO (mean age 37.6 19.3 months, 24 boys). In 21 eyes (39%) MCI was the initial treatment of CNLDO and in the remaining 33 eyes (61%) MCI was performed following a previously failed probing. Children who underwent primary treatment (mean age 46.7 5.3 months) were significantly older than children who had repeat treatment (mean age 30.6 2.2 months, P = 0.004). Thirty-eight children had unilateral intubation (14 right eyes, 24 left eyes) and 8 children had both eyes intubated. The Monoka Ritleng tube was used in 38 eyes (70%) and the Monoka Crawford tubes was used in 16 eyes (30%). Twenty-four tubes (44%) of 19 children were lost before intended retrieval in the office was achieved. Mean duration of intubation in eyes with early tube-loss (2.5 0.5 months) was significantly shorter than in eyes in which tubes were removed as planned (4.7 0.3 months, P = 0.0007). Mean age of children who prematurely lost their tubes was not different compared to children with full tube retention (Table 1). Sex, type of silicone tube used and whether intervention was a first procedure vs. a repeat procedure were also not significantly different in children with early tube-loss and those who had the tubes removed as scheduled. The only statistically significant difference between these groups was in laterality of CNLDO. Seven of eight (88%) children with bilateral CNLDO prematurely lost their tubes (five of them lost both tubes and two lost one of the tubes) compared to 12/38 tubes (31%) lost in children with unilateral CNLDO (P = 0.005). Multivariate regression analysis identified bilateral intubation as an important predictor of premature tube-loss (Table 2). Treatment success in eyes with early tube-loss (17/24 eyes, 71%) was lower than in eyes with full tube retention (25/30 eyes, 83%), however this difference was not statistically significant (P = 0.333). Duration of intubation was found to be the most important factor affecting treatment success (r = 0.51, P = 0.02) by multivariate regression analysis, Table 3. In our study, eyes with less than 2 months intubation had a lower cure rate. Surgical success was observed in 33 out of 39 eyes (85%) in which the tubes remained in place at least 2 months compared to 7 out 15 eyes (47%) with a shorter duration of intubation (P = 0.012). We found similar rates of premature tube-loss following primary CNLDO treatment (7/21 eyes, 33%) and secondary treatment (17/33 eyes, 51%, P = 0.263). Surgical outcome was also similar in these groups, 76% in eyes undergoing initial treatment vs. 73% in eyes undergoing repeat treatment (P = 1.000).
Table 1 Comparison of duration of intubation, age, sex, laterality of congenital nasolacrimal duct obstruction, model of monocanalicular silicone tube used, and first vs. second intervention in children who had premature silicone tube loss compared to children with fully retained tubes.
Intubation (months) Age (months) Sex Laterality Model Procedure
Prematurely removed tubes
Fully retained tubes
P-value
2.5 0.5 39.6 4.10 Boys 11/24 (45.8%) Bil. 7/8 (87.5%)
Girls 8/22 (36.4%) Uni. 12/38 (31.6%)
4.7 0.3 34.7 3.8 Boys 13/24 (54.2%) Bil. 1/8 (12.5%)
0.0007*,a 0.398a 0.561b
Rietleng 15/38 (39.5%) First 7/21 (33.3%)
Crawford 9/16 (56.3%) Repeat 17/33 (51.5%)
Rietleng 23/38 (60.5%) First 14/21 (66.6%)
Bil., bilateral congenital nasolacrimal duct obstruction; Uni., unilateral congenital nasolacrimal duct obstruction. * Statistically significant results. a Unpaired t-test. b Fisher’s exact test.
Girls 14/22 (63.6%) Uni. 26/38 (68.4%) Crawford 7/16 (43.8%) Repeat 16/33 (48.5%)
0.005*,b 0.369b 0.263b
G. Dotan et al. / International Journal of Pediatric Otorhinolaryngology 79 (2015) 301–304 Table 2 Multivariate regression analysis evaluating age, sex, bilaterality of intubation, tube model, and intervention (first vs. second) as predictors of early tube loss. Factor
Correlation coefficient
Age Sex Bilaterality Tube model Intervention
0.00 0.16 0.54 0.02 0.08
*
Lower 95% confidence interval 0.00 0.44 0.15 0.28 0.23
Upper 95% confidence interval
P-value
0.00 0.12 0.93 0.33 0.40
0.795 0.254 0.006* 0.336 0.587
Statistically significant result.
Table 3 Multivariate regression analysis evaluating age, sex, bilaterality of intubation, tube model, intervention (first vs. second), early tube loss, and duration of silicone intubation as predictors of treatment success. Factor
Correlation coefficient
Age Sex Bilaterality Tube model Intervention Silicone retention >2 m Early tube-loss
0.00 0.04 0.18 0.23 0.05 0.51 0.01
*
Lower 95% confidence interval 0.00 0.29 0.18 0.04 0.33 0.19 0.29
Upper 95% confidence interval
P-value
0.00 0.21 0.54 0.50 0.22 0.84 0.31
0.619 0.743 0.320 0.093 0.702 0.002* 0.947
Statistically significant result.
4. Discussion Monocanalicular silicone intubation is an accepted treatment of CNLDO [8]. Despite having many advantages over bicanalicular intubation, it also has several important disadvantages, including greater tendency for spontaneous tube dislodgement with eye rubbing, and easier self-removal by the child [7]. The reported incidence of this complication varies significantly in different publications, ranging from 3% in some studies to as high as 44% in others (Table 4) [1,2,4,7–12]. Our 44% incidence of premature tubeloss is comparable to that reported by Kaufaman et al. [8]; however it is significantly higher than in other studies. It is difficult to understand the large variability of this post-operative complication seen in different pediatric populations; however it is possible that some children have a reduced ability to tolerate a foreign object placed in the eyelid for a prolonged period of time. In addition, climatic or environmental factors may affect the occurrence of premature tube-loss, as warm, dry conditions or increased frequency of seasonal allergy may contribute to eye rubbing behavior. Although we specifically instructed caregivers not to allow any eye-rubbing or eyelid manipulation by the child, these instructions were often useless, as children cannot be watched 24 h a day. Yazici et al. [13] attempted to reduce the rate of premature tube dislodgment by suturing the silicone tube to the
303
nasal mucosa with an absorbable suture; however, in their study 21% of tubes were prematurely lost despite this measure, which was found to be effective only temporarily, in the immediate postoperative period. Theoretically, it can be assumed that age would be an important factor in development of premature tube-loss. Older children can be better instructed not to touch their eye and to avoid eye rubbing; however, they also possess improved motor skills allowing tube self-withdrawal. Huang et al. [12] reported that older children are less prone to early tube dislodgement, as in their study all children with this complication were younger than 4 years of age. On the other hand, Engel et al. [2] found that the age of children whose tubes were prematurely lost was not different than that of children whose tubes were removed in the office as intended. In our study, we similarly found that age is not an important predictor of early tube-loss. It seems that no age is immune from this complication, as it can occur in adults as well [14]. Our analysis identified bilateral CNLDO as the most important predictor of premature tube-loss. We found that children who had both eyes intubated lost their tubes more often than children who had only one eye intubated. It is possible that having silicone tubes in both puncti and nasolacrimal ducts results in greater discomfort to the child, leading to excessive eye rubbing or eyelid manipulations. Previous studies analyzing the effect of premature tube-loss on surgical outcome have provided contradictory results. Kaufman et al. [8] found a 52% cure rate in cases of early tube withdrawal compared to 78% success rate in cases with full tube retention. In the study of Fayet et al. [11] duration of intubation in failed cases was shorter than in successful cases. Yazici et al. [13] reported a 30% failure rate in cases of early tube-loss compared to 10% in all other cases. Contrary to these reports, other studies did not find a change in outcome when tubes were lost earlier than intended [2,15,16]. There is also a controversy in the ophthalmic literature regarding the minimal duration that tubes should remain in place in order to achieve a successful outcome. Some believe that duration of intubation should be no less than 4–6 months [8], while others think that a successful outcome can be achieved with a much shorter intubation, reporting on good outcome after 4–6 weeks of intubation [7,15]. Our results showed that surgical success was achieved less often when tubes remained in place for less than 2 months from surgery (47% vs. 85%). A similar finding was reported in a study of the Pediatric Ophthalmology Investigators Group (PEDIG) in which children who had less than 2 months of intubation were more likely to suffer from persistent epiphora and return of CNLDO symptoms compared to children whose duration of intubation was longer [4]. This study has limitations including its retrospective design. Our study was done on children operated at one medical center, and we found a higher than usual rate of premature tube-loss in these children. Findings on this pediatric population may not apply to other countries or geographic regions, and other studies may be
Table 4 Incidence of premature loss of monocanlicular silicone tubes in different countries. First author
Year of publication
Country
Model of MCI
Punctum
Rate of premature tube-loss (%)
Andalib et al. Repka et al. Komı´nek et al. Goldstein et al. Fayet et al. Engel et al. Huang et al. Lee et al. Kaufman et al.
2010 2008 2011 2004 2012 2008 2009 2012 1998
Iran USA (multiple states) Czech Republic USA (PA) France USA (IL, NJ) Taiwan Korea USA (IL)
Fayet-Bernard Model not specified Model not specified Ritleng Masterka Model not specified Ritleng Model not specified Ritleng
Lower Either Lower Upper Upper Either Lower Lower Upper
3 7 7 11 15 15 19 17 44
304
G. Dotan et al. / International Journal of Pediatric Otorhinolaryngology 79 (2015) 301–304
required to allow comparison. On the other hand, the high incidence of premature tube-loss in our study allowed a better identification of risk factors for this complication and analysis of its effect on outcome. Another limitation is the use of two types of Monoka tubes. However, since both are produced by the same manufacturer and differ only in the way the tube is retrieved during the procedure, we do not think that this difference influenced our results. In conclusion, we found that premature loss of monocanalicular silicone tubes can occur frequently in certain populations, adversely affecting treatment success, especially when happening less than 2 months from surgery.
[6]
[7]
[8]
[9]
[10]
References [11] [1] D. Andalib, D. Gharabaghi, R. Nabai, M. Abbaszadeh, Monocanalicular versus bicanalicular silicone intubation for congenital nasolacrimal duct obstruction, J. AAPOS 14 (2010) 421–424. [2] J.M. Engel, C. Hichie-Schmidt, A. Khammar, B.M. Ostfeld, A. Vyas, B.H. Ticho, Monocanalicular silastic intubation for the initial correction of congenital nasolacrimal duct obstruction, J. AAPOS 11 (2007) 183–186. [3] Pediatric Eye Disease Investigator Group, M.X. Repka, B.M. Melia, R.W. Beck, C.S. Atkinson, D.L. Chandler, et al., Primary treatment of nasolacrimal duct obstruction with nasolacrimal duct intubation in children younger than 4 years of age, J. AAPOS 12 (2008) 445–450. [4] M.X. Repka, D.L. Chandler, J.M. Holmes, D.L. Hoover, C.L. Morse, S. Schloff, et al., Balloon catheter dilation and nasolacrimal duct intubation for treatment of nasolacrimal duct obstruction after failed probing, Arch. Ophthalmol. 127 (2009) 633–639. [5] H. Lee, J. Ahn, H.H. Shin, M. Park, S. Baek, Effectiveness of primary monocanalicularnasal intubation with Monoka tubes and nasal endoscopic findings for
[12]
[13]
[14]
[15]
[16]
congenital nasolacrimal duct obstruction with enlarged lacrimal sac and chronic dacryocystitis, J. Craniofac. Surg. 23 (2012) 1638–1641. Y.H. Al-Faky, N. Al-Sobaie, A. Mousa, H. Al-Odan, R. Al-Huthail, E. Osman, et al., Evaluation of treatment modalities and prognostic factors in children with congenital nasolacrimal duct obstruction, J. AAPOS 16 (2012) 53–57. H. Lee, J. Ahn, J.M. Lee, M. Park, S. Baek, Clinical effectiveness of monocanalicular and bicanalicular silicone intubation for congenital nasolacrimal duct obstruction, J. Craniofac. Surg. 23 (2012) 1010–1014. L.M. Kaufman, L.A. Guay-Bhatia, Monocanalicular intubation with Monoka tubes for the treatment of congenital nasolacrimal duct obstruction, Ophthalmology 105 (1998) 336–341. P. Kominek, S. Cervenka, T. Pniak, K. Zelenik, H. Tomaskova, P. Matousek, Monocanalicular versus bicanalicular intubation in the treatment of congenital nasolacrimal duct obstruction, Graefes Arch. Clin. Exp. Ophthalmol. 249 (2011) 1729–1733. S.M. Goldstein, J.B. Goldstein, J.A. Katowitz, Comparison of monocanalicular stenting and balloon dacryoplasty in secondary treatment of congenital nasolacrimal duct obstruction after failed primary probing, Ophthal. Plast. Reconstr. Surg. 20 (2004) 352–357. B. Fayet, W.R. Katowitz, E. Racy, J.M. Ruban, J.A. Katowitz, Pushed monocanalicular intubation: an alternative stenting system for the management of congenital nasolacrimal duct obstructions, J. AAPOS 16 (2012) 468–472. Y.H. Huang, S.L. Liao, L.L. Lin, Balloon dacryocystoplasty and monocanalicular intubation with Monoka tubes in the treatment of congenital nasolacrimal duct obstruction, Graefes Arch. Clin. Exp. Ophthalmol. 247 (2009) 795–799. B. Yazici, C. Akarsu, M. Salkaya, Silicone intubation with the Ritleng method in children with congenital nasolacrimal duct obstruction, J. AAPOS 10 (2006) 328–332. M.B. Kashkouli, R.C. Kempster, G.D. Galloway, B. Beigi, Monocanalicular versus bicanalicular silicone intubation for nasolacrimal duct stenosis in adults, Ophthal. Plast. Reconstr. Surg. 21 (2005) 142–147. N.J. Peterson, R.G. Weaver, R.P. Yeatts, Effect of short-duration silicone intubation in congenital nasolacrimal duct obstruction, Ophthal. Plast. Reconstr. Surg. 24 (2008) 167–171. C.S. Lim, F. Martin, T. Beckenham, R.G. Cumming, Nasolacrimal duct obstruction in children: outcome of intubation, J. AAPOS 8 (2004) 466–472.
Contents lists available at ScienceDirect
International Journal of Pediatric Otorhinolaryngology journal homepage: www.elsevier.com/locate/ijporl
Early loss of monocanalicular silicone tubes in congenital nasolacrimal duct obstruction: Incidence, predictors, and effect on outcome Gad Dotan a,b,*, Oded Ohana a, Igal Leibovitch a, Chaim Stolovitch a a b
Department of Ophthalmology, Tel Aviv Sourasky Medical Center, Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel Maccabi Healthcare Services, Ramat Hasharon, Israel
A R T I C L E I N F O
A B S T R A C T
Article history: Received 11 May 2014 Received in revised form 22 September 2014 Accepted 25 September 2014 Available online 5 October 2014
Purpose: To study predictors and implications on outcome of premature silicone tube-loss, a postoperative complication of monocanalicular intubation (MCI) performed for treatment of congenital nasolacrimal duct obstruction (CNLDO). Methods: We conducted a retrospective analysis of cases of post-operative loss of monocanalicular silicone tubes occurring at one medical center from January 2007 to December 2013. Results: During the study period monocanclicular silicone tubes were lost in 24/54 eyes (44%) of 19/46 children. Multivariate regression analysis identified bilateral intubation as an important predictor of early tube-loss (r = 0.54, P = 0.006). Seven of eight (88%) children who had both eyes intubated prematurely lost their tubes compared to 12/38 (32%) children who had unilateral intubation (P = 0.005). Treatment success was lower in eyes with early tube-loss (17/24 eyes, 71%) compared to eyes with full tube retention (25/30 eyes, 83%), however this difference was not statistically significant (P = 0.333). In our study, treatment outcome correlated with duration of intubation (r = 0.51, P = 0.002). Surgical success was achieved in 33/39 eyes (85%) in which the tubes were retained at least 2 months compared to 7/15 eyes (47%) with shorter period of intubation (P = 0.012). Conclusions: Spontaneous tube-loss is a post-operative complication of monocanalicular silicone intubation that can occur more frequently than previously reported in certain populations. Tube-loss occurring soon after surgery is often associated with persistent symptoms and increased need of reoperation. ß 2014 Elsevier Ireland Ltd. All rights reserved.
Keywords: Congenital nasolacrimal duct obstruction Monocanalicular silicone tube intubation
1. Introduction Silicone tube intubation of the nasolacrimal duct is a frequently performed procedure for treatment of congenital nasolacrimal duct obstruction (CNLDO) [1–4]. The procedure can be performed in a monocanalicular fashion, through either the upper or lower canaliculus, or in a bicanalicular fashion through both [1–3,5]. The added benefit of the silicone tube that maintains patency of the nasolacrimal duct during the healing process following intubation improves cure rate compared to conventional probing alone [6,7]. Since its introduction in the early 1990s, monocanalicular intubation (MCI) has gained increasing popularity; its numerous advantages which include a shorter procedure time, a single pass
* Corresponding author at: Department of Ophthalmology, Tel Aviv Medical Center, 6 Weizmann Street, Tel Aviv 64239, Israel. Tel.: +972 3 6925773; fax: +972 3 6925693. E-mail address: [email protected] (G. Dotan). http://dx.doi.org/10.1016/j.ijporl.2014.09.027 0165-5876/ß 2014 Elsevier Ireland Ltd. All rights reserved.
through just one canaliculus avoiding the risk of iatrogenic damage to the unprobed canaliculus, and an easier removal, usually performed in the office, appeal to many surgeons [3,7]. However, easier tube retrieval also means increased risk of premature tubeloss and possible self-removal by the child [7]. Although this is a recognized complication of MCI, predictors of its occurrence have not been well studied and controversy remains regarding its effect on outcome. This study analyzed cases of early tube-loss following MCI in order to better understand this postoperative complication. 2. Methods The Institutional Review Board of the Tel Aviv Medical Center approved this study of children who underwent MCI for treatment of CNLDO from January 2007 to December 2013 (study # TLV0455-14) and its performance was in accordance with its rules and regulations. This study was exempt from informed consent because of its retrospective design and minimal risk involved with its design.
302
G. Dotan et al. / International Journal of Pediatric Otorhinolaryngology 79 (2015) 301–304
All children had MCI, which was typically performed when primary CNLDO treatment was done at an older age (>2 years) or following a previously failed probing procedure. Children were identified through a computerized search of the hospital’s database. All children had an established diagnosis of CNLDO based on presence of epiphora, increased tear lake, or mucopurulent discharge without ocular irritation or upper respiratory tract infection beginning before the age of 6 months. Children with Down’s syndrome, craniofacial abnormalities, and eyelid or punctum anomalies were excluded from the study. All procedures were performed under general anesthesia with endotracheal intubation. Probing was universally performed before monocanalicular silicone intubation. Either the Ritleng Monoka or the Monoka-Crawford tubes (FCI ltd., Paris, France) were used in all cases. Following insertion of the silicone tube into the nasolacrimal duct through the lower punctum it was retrieved in the nasal cavity with a Ritleng or Crawford hook and was pulled out from the nose. The excess silicone protruding from the nostril was trimmed, and the punctal plug was secured in the lower eyelid. At the completion of the procedure an antibiotic-steroid drop was applied to the operated eye and was continued three times daily for two weeks. Intended duration of intubation was between 4 and 6 months, and all tubes were supposed to be removed in the office while the child is awake by grasping and removing the punctal plug with forceps. Treatment outcome was determined one month following tube removal and a successful outcome was considered when there was complete resolution of all preoperative CNLDO symptoms and signs. Children were reported as having premature tube-loss if the tube was found missing on a routine follow-up visit less than 4 months from surgery or the family of the child became aware of a missing tube. Duration of intubation in cases of early tube displacement was calculated from the day of insertion to the last follow-up visit in which the tube was seen in place or to the date the family noticed the tube was missing. Statistical analysis was performed using Prism 6 statistical software (GraphPad Software Inc., San Diego, CA). Descriptive statistics is provided. Statistical significance was set at an alpha level of 5% and all statistical tests performed were two-tailed. Unpaired t-test was used for analysis of age and duration of intubation of children who had early tube-loss compared to children whose tubes were removed in the office as planned. Fisher’s exact test was used for analysis of categorical variables, including sex, laterality of CNLDO, type of monocanlicular tube used, and type of intervention (first vs. repeat procedures). A multivariate regression analysis was calculated for factors associated with premature tube-loss and surgical success.
3. Results During the study period MCI was performed in 54 eyes of 46 children with CNLDO (mean age 37.6 19.3 months, 24 boys). In 21 eyes (39%) MCI was the initial treatment of CNLDO and in the remaining 33 eyes (61%) MCI was performed following a previously failed probing. Children who underwent primary treatment (mean age 46.7 5.3 months) were significantly older than children who had repeat treatment (mean age 30.6 2.2 months, P = 0.004). Thirty-eight children had unilateral intubation (14 right eyes, 24 left eyes) and 8 children had both eyes intubated. The Monoka Ritleng tube was used in 38 eyes (70%) and the Monoka Crawford tubes was used in 16 eyes (30%). Twenty-four tubes (44%) of 19 children were lost before intended retrieval in the office was achieved. Mean duration of intubation in eyes with early tube-loss (2.5 0.5 months) was significantly shorter than in eyes in which tubes were removed as planned (4.7 0.3 months, P = 0.0007). Mean age of children who prematurely lost their tubes was not different compared to children with full tube retention (Table 1). Sex, type of silicone tube used and whether intervention was a first procedure vs. a repeat procedure were also not significantly different in children with early tube-loss and those who had the tubes removed as scheduled. The only statistically significant difference between these groups was in laterality of CNLDO. Seven of eight (88%) children with bilateral CNLDO prematurely lost their tubes (five of them lost both tubes and two lost one of the tubes) compared to 12/38 tubes (31%) lost in children with unilateral CNLDO (P = 0.005). Multivariate regression analysis identified bilateral intubation as an important predictor of premature tube-loss (Table 2). Treatment success in eyes with early tube-loss (17/24 eyes, 71%) was lower than in eyes with full tube retention (25/30 eyes, 83%), however this difference was not statistically significant (P = 0.333). Duration of intubation was found to be the most important factor affecting treatment success (r = 0.51, P = 0.02) by multivariate regression analysis, Table 3. In our study, eyes with less than 2 months intubation had a lower cure rate. Surgical success was observed in 33 out of 39 eyes (85%) in which the tubes remained in place at least 2 months compared to 7 out 15 eyes (47%) with a shorter duration of intubation (P = 0.012). We found similar rates of premature tube-loss following primary CNLDO treatment (7/21 eyes, 33%) and secondary treatment (17/33 eyes, 51%, P = 0.263). Surgical outcome was also similar in these groups, 76% in eyes undergoing initial treatment vs. 73% in eyes undergoing repeat treatment (P = 1.000).
Table 1 Comparison of duration of intubation, age, sex, laterality of congenital nasolacrimal duct obstruction, model of monocanalicular silicone tube used, and first vs. second intervention in children who had premature silicone tube loss compared to children with fully retained tubes.
Intubation (months) Age (months) Sex Laterality Model Procedure
Prematurely removed tubes
Fully retained tubes
P-value
2.5 0.5 39.6 4.10 Boys 11/24 (45.8%) Bil. 7/8 (87.5%)
Girls 8/22 (36.4%) Uni. 12/38 (31.6%)
4.7 0.3 34.7 3.8 Boys 13/24 (54.2%) Bil. 1/8 (12.5%)
0.0007*,a 0.398a 0.561b
Rietleng 15/38 (39.5%) First 7/21 (33.3%)
Crawford 9/16 (56.3%) Repeat 17/33 (51.5%)
Rietleng 23/38 (60.5%) First 14/21 (66.6%)
Bil., bilateral congenital nasolacrimal duct obstruction; Uni., unilateral congenital nasolacrimal duct obstruction. * Statistically significant results. a Unpaired t-test. b Fisher’s exact test.
Girls 14/22 (63.6%) Uni. 26/38 (68.4%) Crawford 7/16 (43.8%) Repeat 16/33 (48.5%)
0.005*,b 0.369b 0.263b
G. Dotan et al. / International Journal of Pediatric Otorhinolaryngology 79 (2015) 301–304 Table 2 Multivariate regression analysis evaluating age, sex, bilaterality of intubation, tube model, and intervention (first vs. second) as predictors of early tube loss. Factor
Correlation coefficient
Age Sex Bilaterality Tube model Intervention
0.00 0.16 0.54 0.02 0.08
*
Lower 95% confidence interval 0.00 0.44 0.15 0.28 0.23
Upper 95% confidence interval
P-value
0.00 0.12 0.93 0.33 0.40
0.795 0.254 0.006* 0.336 0.587
Statistically significant result.
Table 3 Multivariate regression analysis evaluating age, sex, bilaterality of intubation, tube model, intervention (first vs. second), early tube loss, and duration of silicone intubation as predictors of treatment success. Factor
Correlation coefficient
Age Sex Bilaterality Tube model Intervention Silicone retention >2 m Early tube-loss
0.00 0.04 0.18 0.23 0.05 0.51 0.01
*
Lower 95% confidence interval 0.00 0.29 0.18 0.04 0.33 0.19 0.29
Upper 95% confidence interval
P-value
0.00 0.21 0.54 0.50 0.22 0.84 0.31
0.619 0.743 0.320 0.093 0.702 0.002* 0.947
Statistically significant result.
4. Discussion Monocanalicular silicone intubation is an accepted treatment of CNLDO [8]. Despite having many advantages over bicanalicular intubation, it also has several important disadvantages, including greater tendency for spontaneous tube dislodgement with eye rubbing, and easier self-removal by the child [7]. The reported incidence of this complication varies significantly in different publications, ranging from 3% in some studies to as high as 44% in others (Table 4) [1,2,4,7–12]. Our 44% incidence of premature tubeloss is comparable to that reported by Kaufaman et al. [8]; however it is significantly higher than in other studies. It is difficult to understand the large variability of this post-operative complication seen in different pediatric populations; however it is possible that some children have a reduced ability to tolerate a foreign object placed in the eyelid for a prolonged period of time. In addition, climatic or environmental factors may affect the occurrence of premature tube-loss, as warm, dry conditions or increased frequency of seasonal allergy may contribute to eye rubbing behavior. Although we specifically instructed caregivers not to allow any eye-rubbing or eyelid manipulation by the child, these instructions were often useless, as children cannot be watched 24 h a day. Yazici et al. [13] attempted to reduce the rate of premature tube dislodgment by suturing the silicone tube to the
303
nasal mucosa with an absorbable suture; however, in their study 21% of tubes were prematurely lost despite this measure, which was found to be effective only temporarily, in the immediate postoperative period. Theoretically, it can be assumed that age would be an important factor in development of premature tube-loss. Older children can be better instructed not to touch their eye and to avoid eye rubbing; however, they also possess improved motor skills allowing tube self-withdrawal. Huang et al. [12] reported that older children are less prone to early tube dislodgement, as in their study all children with this complication were younger than 4 years of age. On the other hand, Engel et al. [2] found that the age of children whose tubes were prematurely lost was not different than that of children whose tubes were removed in the office as intended. In our study, we similarly found that age is not an important predictor of early tube-loss. It seems that no age is immune from this complication, as it can occur in adults as well [14]. Our analysis identified bilateral CNLDO as the most important predictor of premature tube-loss. We found that children who had both eyes intubated lost their tubes more often than children who had only one eye intubated. It is possible that having silicone tubes in both puncti and nasolacrimal ducts results in greater discomfort to the child, leading to excessive eye rubbing or eyelid manipulations. Previous studies analyzing the effect of premature tube-loss on surgical outcome have provided contradictory results. Kaufman et al. [8] found a 52% cure rate in cases of early tube withdrawal compared to 78% success rate in cases with full tube retention. In the study of Fayet et al. [11] duration of intubation in failed cases was shorter than in successful cases. Yazici et al. [13] reported a 30% failure rate in cases of early tube-loss compared to 10% in all other cases. Contrary to these reports, other studies did not find a change in outcome when tubes were lost earlier than intended [2,15,16]. There is also a controversy in the ophthalmic literature regarding the minimal duration that tubes should remain in place in order to achieve a successful outcome. Some believe that duration of intubation should be no less than 4–6 months [8], while others think that a successful outcome can be achieved with a much shorter intubation, reporting on good outcome after 4–6 weeks of intubation [7,15]. Our results showed that surgical success was achieved less often when tubes remained in place for less than 2 months from surgery (47% vs. 85%). A similar finding was reported in a study of the Pediatric Ophthalmology Investigators Group (PEDIG) in which children who had less than 2 months of intubation were more likely to suffer from persistent epiphora and return of CNLDO symptoms compared to children whose duration of intubation was longer [4]. This study has limitations including its retrospective design. Our study was done on children operated at one medical center, and we found a higher than usual rate of premature tube-loss in these children. Findings on this pediatric population may not apply to other countries or geographic regions, and other studies may be
Table 4 Incidence of premature loss of monocanlicular silicone tubes in different countries. First author
Year of publication
Country
Model of MCI
Punctum
Rate of premature tube-loss (%)
Andalib et al. Repka et al. Komı´nek et al. Goldstein et al. Fayet et al. Engel et al. Huang et al. Lee et al. Kaufman et al.
2010 2008 2011 2004 2012 2008 2009 2012 1998
Iran USA (multiple states) Czech Republic USA (PA) France USA (IL, NJ) Taiwan Korea USA (IL)
Fayet-Bernard Model not specified Model not specified Ritleng Masterka Model not specified Ritleng Model not specified Ritleng
Lower Either Lower Upper Upper Either Lower Lower Upper
3 7 7 11 15 15 19 17 44
304
G. Dotan et al. / International Journal of Pediatric Otorhinolaryngology 79 (2015) 301–304
required to allow comparison. On the other hand, the high incidence of premature tube-loss in our study allowed a better identification of risk factors for this complication and analysis of its effect on outcome. Another limitation is the use of two types of Monoka tubes. However, since both are produced by the same manufacturer and differ only in the way the tube is retrieved during the procedure, we do not think that this difference influenced our results. In conclusion, we found that premature loss of monocanalicular silicone tubes can occur frequently in certain populations, adversely affecting treatment success, especially when happening less than 2 months from surgery.
[6]
[7]
[8]
[9]
[10]
References [11] [1] D. Andalib, D. Gharabaghi, R. Nabai, M. Abbaszadeh, Monocanalicular versus bicanalicular silicone intubation for congenital nasolacrimal duct obstruction, J. AAPOS 14 (2010) 421–424. [2] J.M. Engel, C. Hichie-Schmidt, A. Khammar, B.M. Ostfeld, A. Vyas, B.H. Ticho, Monocanalicular silastic intubation for the initial correction of congenital nasolacrimal duct obstruction, J. AAPOS 11 (2007) 183–186. [3] Pediatric Eye Disease Investigator Group, M.X. Repka, B.M. Melia, R.W. Beck, C.S. Atkinson, D.L. Chandler, et al., Primary treatment of nasolacrimal duct obstruction with nasolacrimal duct intubation in children younger than 4 years of age, J. AAPOS 12 (2008) 445–450. [4] M.X. Repka, D.L. Chandler, J.M. Holmes, D.L. Hoover, C.L. Morse, S. Schloff, et al., Balloon catheter dilation and nasolacrimal duct intubation for treatment of nasolacrimal duct obstruction after failed probing, Arch. Ophthalmol. 127 (2009) 633–639. [5] H. Lee, J. Ahn, H.H. Shin, M. Park, S. Baek, Effectiveness of primary monocanalicularnasal intubation with Monoka tubes and nasal endoscopic findings for
[12]
[13]
[14]
[15]
[16]
congenital nasolacrimal duct obstruction with enlarged lacrimal sac and chronic dacryocystitis, J. Craniofac. Surg. 23 (2012) 1638–1641. Y.H. Al-Faky, N. Al-Sobaie, A. Mousa, H. Al-Odan, R. Al-Huthail, E. Osman, et al., Evaluation of treatment modalities and prognostic factors in children with congenital nasolacrimal duct obstruction, J. AAPOS 16 (2012) 53–57. H. Lee, J. Ahn, J.M. Lee, M. Park, S. Baek, Clinical effectiveness of monocanalicular and bicanalicular silicone intubation for congenital nasolacrimal duct obstruction, J. Craniofac. Surg. 23 (2012) 1010–1014. L.M. Kaufman, L.A. Guay-Bhatia, Monocanalicular intubation with Monoka tubes for the treatment of congenital nasolacrimal duct obstruction, Ophthalmology 105 (1998) 336–341. P. Kominek, S. Cervenka, T. Pniak, K. Zelenik, H. Tomaskova, P. Matousek, Monocanalicular versus bicanalicular intubation in the treatment of congenital nasolacrimal duct obstruction, Graefes Arch. Clin. Exp. Ophthalmol. 249 (2011) 1729–1733. S.M. Goldstein, J.B. Goldstein, J.A. Katowitz, Comparison of monocanalicular stenting and balloon dacryoplasty in secondary treatment of congenital nasolacrimal duct obstruction after failed primary probing, Ophthal. Plast. Reconstr. Surg. 20 (2004) 352–357. B. Fayet, W.R. Katowitz, E. Racy, J.M. Ruban, J.A. Katowitz, Pushed monocanalicular intubation: an alternative stenting system for the management of congenital nasolacrimal duct obstructions, J. AAPOS 16 (2012) 468–472. Y.H. Huang, S.L. Liao, L.L. Lin, Balloon dacryocystoplasty and monocanalicular intubation with Monoka tubes in the treatment of congenital nasolacrimal duct obstruction, Graefes Arch. Clin. Exp. Ophthalmol. 247 (2009) 795–799. B. Yazici, C. Akarsu, M. Salkaya, Silicone intubation with the Ritleng method in children with congenital nasolacrimal duct obstruction, J. AAPOS 10 (2006) 328–332. M.B. Kashkouli, R.C. Kempster, G.D. Galloway, B. Beigi, Monocanalicular versus bicanalicular silicone intubation for nasolacrimal duct stenosis in adults, Ophthal. Plast. Reconstr. Surg. 21 (2005) 142–147. N.J. Peterson, R.G. Weaver, R.P. Yeatts, Effect of short-duration silicone intubation in congenital nasolacrimal duct obstruction, Ophthal. Plast. Reconstr. Surg. 24 (2008) 167–171. C.S. Lim, F. Martin, T. Beckenham, R.G. Cumming, Nasolacrimal duct obstruction in children: outcome of intubation, J. AAPOS 8 (2004) 466–472.