CONGENITAL NASOLACRIMAL DUCT OBSTRUCTION IN THE SECOND YEAR OF LIFE: A MULTI CENTRE TRIAL OF MANAGEMENT

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1 CONGENITAL NASOLACRIMAL DUCT OBSTRUCTION IN THE SECOND YEAR OF LIFE: A MULTI CENTRE TRIAL OF MANAGEMENT J. D. H. YOUNG\ c. J. MacEWEN! and S. A. OGSTON Dundee Cllabrating surgens: G. J. Bedfrd, Dumfries; W. Church, Aberdeen; L. Esakwitz, Paisley; D. Hlding, Glasgw; E. G. Kemp, Ayr; C. J. MacEwen, Dundee, G. T. Millar, Edinburgh; J. D. H. Yung, Dundee SUMMARY We studied spntaneus reslutin f cngenital naslacrimal duct bstructin in the secnd year f life and cmpared this with the cure rate after prbings undertaken between the ages f 11 and 15 mnths. Of the 111 eyes f 95 patients studied, 6 eyes were included in a randmised prspective cmparisn f prbing with spntaneus reslutin. A further 63 eyes fllwed a similar management plan t the randmised grup and are reprted as an bservatinal study. Thirty f the 50 eyes fllwed up withut treatment reslved spntaneusly befre the age f years, f which 4 reslved befre 18 mnths. The verall cure rate fr prbing was 74% cmpared with 60% fr spntaneus reslutin. At 15 mnths f age the randmised study cnfirmed that prbing at 1-14 mnths is an effective interventin cmpared with spntaneus reslutin (p = 0.04). At 4 mnths f age prbing was superir in bth randmised and nnrandmised studies, but with increased numbers in the spntaneus reslutin grups the difference was n lnger statistically significant. Up t 18 mnths f age the frequency f spntaneus reslutin makes delay in prbing a viable management ptin t be discussed with the parents. It will als lead t an verestimate f the cure rate in any study f interventinal treatment unless cntrls are included. Cngenital naslacrimal duct bstructin (CNLDO) is a cmmn prblem affecting up t 0% f all infants l and by far the cmmnest utcme is spntaneus reslutin withut surgical interventin?- 5 In an bservatinal ppulatin-based chrt Frm: Departments f 1 Ophthalmlgy. and Epidemilgy and Public Health, Ninewells Hspital and Medical Schl, Dundee, UK. Crrespndence t: Dr J. D. H. Yung, Department f Ophthalmlgy, Ninewells Hspital, Dundee DDl 9SY, UK. study, 96% f the affected infants were free f symptms by their first birthday withut treatment. 1 Any treatment prpsed must therefre be evaluated against the baseline f this high rate f spntaneus reslutin. On the same basis the natural histry f the cnditin during the secnd year f life must be knwn t assess fully the results f any interventin, in particular the standard treatment f prbing and syringing the naslacrimal duct. Hwever, published infrmatin n the frequency f spntaneus reslutin after 1 mnths f age is scarce,, 5 with that f Nucci et al.6 being the mst relevant. They reprted that in 3 f 9 patients ver the age f 1 mnths the cnditin reslved within 90 days f cmmencing 'medical' treatment with sac cmpressin and tpical antibitics. The primary purpse f the present study was, therefre, t establish the frequency f spntaneus remissin in presumed CNLDO persisting int the secnd year f life: firstly t determine whether it was cmmn enugh t be cnsidered as a management ptin as it is in the first year f life, and secndly t prvide a baseline against which any interventinal treatments can be assessed. The study was extended t cmpare spntaneus reslutin with the current standard management used by the authrs (prbing at abut age 1 mnths). The study design was fr a prspective cntrlled randmised trial, with prbing at 1-14 mnths f age cmpared with n treatment until 4 mnths. Surgens at seven centres cllabrated in the trial. METHODS All infants presenting with presumed CNLDO during the perid f the study, and wh were appraching r just after their first birthday, were Eye (1996), Ryal Cllege f Ophthalmlgists

2 486 J. D. H. YOUNG ET AL. assessed fr trial entry. The clinical diagnsis f presumed CNLDO was based n a histry f epiphra and/r discharge starting within 3 mnths f birth, and an abnrmal flurescein dye disappearance test (FDDT). The FDDT was perfrmed in a standard manner and recrded at 5 r minutes? When present the clinical signs f discharge, a thick tear meniscus, muccele and skin excriatin supprted the diagnsis, and ther cnditins such as epiblepharn and chlamydial cnjunctivitis were excluded. Data n the severity f the symptms were cllected at presentatin. Parents were asked t grade bth the epiphra and discharge, as nne, intermittent r cnstant. Study Entry Patients were divided int fur grups as fllws. Grup I. All patients having a muccele, r wh had persistent cnjunctival hyperaemia and discharge except while n antibitics, were assumed t have a prer prgnsis fr spntaneus remissin and delay in treatment was cnsidered t be unethical. They were excluded frm randmisatin, placed in grup 1, and prbing advised. Grups and 3. Parents f thse remaining children presenting within the time limits and with n medical cntraindicatin were then given full infrmatin n the nature and purpse f the study, including a parents' infrmatin sheet apprved by Tayside Cmmittee fr Medical Ethics. If infrmed cnsent was btained the child was registered by telephne with the study ffice and a trial number allcated frm randm number tables (sets f 1-16). Children with dd trial numbers were placed in grup and prbed between 1 and 14 mnths. Thse with even trial numbers were placed in grup 3 and prbing delayed until 4 mnths in the hpe f spntaneus remissin. Grup 4. All remaining children, including thse suitable fr the trial, but fr whm infrmed cnsent was nt given, were placed in grup 4 and managed accrding t each clinician's current practice. Children with a histry f previus lacrimal prcedures were excluded. Data were cllected prspectively in a defined rder n a printed trial frm t facilitate standardisatin f methds, and f the randmisatin prcess. Prbing Prbing was carried ut with the child under general anaesthetic, and was perfrmed and recrded using an agreed standard prtcl. Prbing f the naslacrimal duct was via the upper canaliculus but patency f the lwer canaliculus was als cnfirmed with gentle prbing t the sac. The prbe wire sizes used were als standardised between the different centres, and patency f the system judged by the identificatin f diluted flurescein in the nse r naspharynx after syringing. The maximum prbe size used was 00 (diameter 0.73 mm apprx.). In this paper the term 'prbing' is used fr the whle prcedure, including cnfirmatin f patency by syringing flurescein. Fllw-up At each fllw-up visit a standard set f data was cllected. Cure was judged n the basis f a cmplete r near cmplete remissin f symptms and signs and a nrmal FDDT. Because f the pssibility that spntaneus remissin might ccur sme time after a failed prbing, cure frm prbing was defined as reslutin f signs and symptms within 1 mnth f the prcedure. In practice mst cures were identified by parents within a week f the prcedure. Three infants were nt brught back t clinic and nly telephne fllw-up was pssible. Obstacles t Randmisatin Many infants suitable fr the trial were nt randmised. At this age multiple illnesses in children and their families means there are many missed appintments r delayed prbings, and the time limits fr trial entry and prbing were narrw. We als bserved that after parents had read the infrmatin sheet and realised there were chices in management many did nt wish t agree t the lss f cntrl implicit in the randmisatin. The selectin f a full 1 mnths f treatment delay as ne arm f the trial may als have inhibited recruitment. The reasns given fr nn-randmisatin are listed in Table 1. Study Ppulatin A ttal f 1 cmpleted patient data frms were received but 6 were excluded because f incmplete data r lst fllw-up. There were therefre 95 patient recrds (111 affected eyes) available fr analysis. Of these, nly patients (6 eyes) were randmised but a further 55 patients (63 eyes) fllwed a management plan similar t that fr the randmised grup. This larger nn-randmised grup prvides valid bservatinal data in its wn right but is als reprted t allw assessment f any selectin bias in the randmised grups. In the nnrandmised grup the time limits fr prbing were Table I. Reasn recrded Medical decisin Parental decisin Outside time limits Other reasn Nt recrded Ttal Reasns fr nn-randmisatin Patients

3 MANAGEMENT OF CONGENITAL NASOLACRIMAL DUCT OBSTRUCTION 487 relaxed t include patients prbed at mnths rather than 1-14 mnths as in the randmised grup. RESULTS In Table II verall results frm the nn-randmised and randmised grups are presented in parallel t enable cmparisn. In the randmised arm f the study prbing is statistically superir t spntaneus reslutin at 15 mnths, a difference still evident at 4 mnths but n lnger statistically significant. This pattern is als evident with the larger numbers in the nn-randmised grups, but the statistical cmparisn between them must be interpreted with cautin in view f the ptential fr bias in case selectin. If the results f bth studies are cmbined the verall cure rate fr prbing at mnths is 74%, cmpared with 60% fr spntaneus reslutin befre age years. The rate at which spntaneus remissin ccurred during the secnd year f life in bth grups is shwn in Fig. 1. In the whle study 30 f the 50 patients (60%), bserved withut treatment, had had a reslutin f their CNLDO befre their secnd birthday. We planned a randmised trial t exclude the bias that might result frm the parents f the mre severely affected children requesting prbing. Bias might als have ccurred because f the relatively small number f patients in the randmised trial. These pints are addressed in Table III, which reprts the prevalence f the mst severely affected in varius grups. Hwever, as there is a subjective element in these classificatins and the grups are f different size, these results can nly exclude any grss discrepancies in severity between the grups. The incidence f almst cnstant discharge in the prbed grups (36%) is greater than that in the delayed treatment grups (6%), but the difference is nt statistically significant. If the grup 1 patients wh were prbed n medical advice and the randmised patients are excluded, the incidence f almst cnstant discharge is 6% (5 f 19) in the prbed grup and 9% ( f 34) in the delayed treatment grup. We als wished t establish whether the severity at presentatin culd predict the chance f cure by either prbing r spntaneus reslutin. Table IV shws that n majr assciatin between severity at presentatin and cure was demnstrated. Hwever, there was a small grup f 5 patients wh had epiphra and an abnrmal FDDT but whse parents reprted n discharge. All 5 shwed spntaneus reslutin and while the numbers are small the trend appraches significance (p = 0.063, chi-squared test fr trend). The utcmes in thse patients whse treatment failed are shwn in Table V. It is f interest that in bth grups spntaneus reslutin cntinued t ccur, with a further 5 eyes reslving after age years. The results fr the grup 1 patients are shwn separately in Table VI. These are the patients excluded frm randmisatin n the assumptin Table II. Summary f the results f bth studies Randm/sed Cntrlled Study 6 Eyes ( patients) Grup Grup 3 Prspective Observatinal Study 63 Eyes (55 patients) Grup 1 Grup 4 Cmbined Data (89 Eyes) Prbed at N treatment 1-14 mnths t 4 mnths Prbed at N treatment t mnths 4 mnths Prbed at N treatment t mnths 4 mnths 15 mnths 4 mnths 15 mnths 4 mnths Cure Fail Cure Rate 80% 31% 43% 73% 7% 68% 74% 60% At 15 mnths prbing Is superir t n treatment p = 0.04 (Vates x, ). At 4 mnths there Is n statistically significant difference between the grups. At 15 mnths prbing Is superir t n treatment p = (Vates x,). At 4 mnths there is n statistically significant difference between the grups. At 4 mnths there Is n statistically significant difference between the grups. In the nn-randmlsed grups the statistical cmparisns must be treated with ceutin as sme bias in case selectin cannt be excluded. The figures are reprted t shw the cnsistency with results f the randmlsed study. At 15 mnths there are three additinal patients in the bservatinal study - wh were then prbed befre 4 mnths.

4 488 J. D. H. YOUNG ET AL Eyes Watering N. f eyes (Mnths) Spntaneus Reslutin - Spntaneus Reslutin - Eyes Reslving mnths 19 4 mnths 48% (4/50) 3% (616) Observatinal Grup Randmised Grup The rate f spntaneus reslutin in mnths 19-4 was nly half that in mnths and this difference reaches brderline statistical significance. p = 0.06 Yates X Fig. 1. Randmised and bservatinal studies: spntaneus reslutin. that with severe symptms the chances f spntaneus reslutin wuld be less and delay in prbing therefre unjustified. In fact the numbers and cure rate at 80% was exactly the same as that fr the randmised patients wh were prbed, and a further patients shwed spntaneus reslutin befre they culd be prbed. Finally sme data n the prbings in the whle study grup are reprted (111 eyes f 95 patients). Of the 60 prbings undertaken in this study 5 (4%) were graded as easy with n detectable bstructin t the prbe. Of these, 7 cases failed t reslve after the initial prbing but 3 then reslved spntaneusly befre any further treatment. In 0 (33%) there was a detectable bstructin at the lwer end f the naslacrimal duct (NLD), and in 6 (%) the Table III. The severity f symptms Randm/sad Nn-randm/.ed (1) Randmlsed v Nn-Randmlsed Cnstant discharge 5 (19%) 3 (36%) Cnstant Epiphra 15 (58%) 36 (57%) Treatment de/eyed Prbed () Delay f treatment t 4 mnths v Prbing at mnths Cnstant discharge 13 (6%) 15 (38%) Cnstant Epiphra 6 (5%) 5 (64%) Parents graded the symptms f watering and discharge as nne, Intarmlttent r cnstant. The number whh the mst severe gracle f each symptm Is shwn and as a percentage f Hs grup In brackets. There Is n statistically sign III cant dlfferenca between the grups (X' _)

5 MANAGEMENT OF CONGENITAL NASOLACRIMAL DUCT OBSTRUCTION 489 Table IV. Des the severity f symptms predict the result f treatment? Prbing at mnths Watering Discharge Cure Fall Cure Fail Cnstant 19 6 Cnstant 6 Spntaneus reslutin by 4 mnths Watering Cure Fall Discharge Cure Fail Cnstant 16 Cnstant 6 7 There was n statistically significant assciatin between severity f symptms and the results f treatment. All 5 patients with watarlng but n discharge in the delayed treatment grup reslved spntaneusly. Despite the small numbers this is suggestive f trend ex' p = 0.063) bstructin was at the upper end f the NLD. In the remaining 9 eyes (15%) severe bstructin t the prbe was recrded; 5 f these cases were cured by their initial prbing. In 4 patients (5 eyes) excluded frm the randmised r bservatinal studies, severe punctal stensis r cclusin was cnsidered t explain the epiphra. Their lacrimal passages were therwise nrmal and all were cured by punctal dilatin and prbing. Bleeding frm the punctum was recrded in 1 (0%) f the 60 eyes prbed; f these, 8 were cured by the prcedure and 4 were nt. DISCUSSION The first bjective f this study was t determine whether the spntaneus reslutin f CNLDO is f clinical significance in the secnd year f life. With 30 f the 50 patients (60%) bserved withut treatment shwing spntaneus reslutin by their secnd birthday this clearly is the case, and parents shuld be invited t cnsider delayed treatment as ne f the ptins fr management. The data are als very suggestive f a decrease in the frequency f spntaneus remissin after 18 mnths f age. Althugh this difference nly reaches brderline statistical significance (p = 0.06, Yates' chi-squared), in the absence f alternative data we cnsider it shuld be incrprated int the clinical management plan fr thse children whse parents have elected t defer prbing. Shuld there still be n sign f spntaneus reslutin, the age f 18 mnths appears t be an apprpriate time t recnsider prbing. We als bserved spntaneus reslutin in 7 eyes in the third year f life. The knwledge that spntaneus reslutin may still ccur after years f age may be relevant t the parents f children with mild symptms wh wuld prefer t avid interventin if pssible. Our study has shwn that spntaneus reslutin remains a cmmn ccurrence in the secnd year f life and this infrmatin shuld be taken int accunt when assessing the merits f the many treatments that have been prpsed fr CNLDO. At all ages Table V. Outcme after failure f treatment Table VI. Grup 1 results Outcms After Failure f Spntaneus Reslutin by 4 Mnths Outcme Randm/sed Nn randmised Spntaneus reslutin Cure after prbing Ttal Nn-randm/sed severe symptms. Muccele r recurrent cnjuncl/vitis with hyperaemia 13 patients (15 eyes) Fall after prbing Spntaneus reslutin after prbing Prbed spntaneus Res/utin Lst t fllw up Ttal 9 11 Outcme After Failure f Prbina at Mnths mnths Cure 8 16 & 17 mnths (14 & 16 mnths) Outcme Cmments Fall Spntaneus reslutin Further prcedure Lst t fllw up Ttal, 3 & 17 mnths after prbing 3 prbing, 1 Intubatin After failure recrded The cure rate fr prbing at mnths Is exactly the same as that in the randmised patients wh were prbed.

6 490 uncntrlled studies f any frm f interventinal treatment will be likely t verestimate the cure rate. Fr example, naslacrimal duct intubatin after failed prbing has never been evaluated against a cntrl grup. The apparent imprvement in the success rate btained by leaving the intubatin in situ fr 7-1 mnths 8. 9 may result partly frm masked spntaneus remissin. Hwever, the present study has illustrated the prblems in btaining cntrl grups in this cnditin and in sme situatins the data we have presented may be useful as a guide when analysing reprts f interventinal treatment. There may als be ccasins when intubatin after a failed prbing is undertaken unnecessarily. If there is failure f an apparently easy prbing, with n resistance t the prbe and with patency t flurescein, then there may be n anatmical bstructin fr prbing r intubatin t cure. We speculate that in sme cases presumed CNLDO may result frm pr lacrimal pump functin, perhaps due t narrw lacrimal passages in infancy. Three patients in this study shwed late spntaneus reslutin, after prbing graded as easy had failed. In this categry f patient we nw advise delay until 4 mnths f age in the hpe f spntaneus reslutin, befre cnsidering intubatin f such anatmically patent systems. The secnd aim f the study was t reassess prbing by cmparing its results with spntaneus reslutin. The numbers in the randmised study are smaller than intended fr the reasns already given. Despite these small numbers sme cnclusins are pssible. At 15 mnths the cure rate fr patients prbed at 1-14 mnths was 80% cmpared with 31 % fr n treatment, and this difference is statistically significant - a pattern replicated in the nn-randmised grup. This prvides the first cnfirmatin frm a cntrlled study that prbing at 1-14 mnths is an effective interventin cmpared with the backgrund rate f spntaneus remissin. In bth randmised and nn-randmised grups prbing still appears superir at 4 mnths, but the increased number f cases with spntaneus reslutin in the n-treatment grups means that the difference is nt statistically significant. The apparent advantage f prbing at 1-14 mnths des nt mean that it is necessarily the treatment f chice fr all patients. Many parents will be mre cncerned at the prspect f perative interventin and an anaesthetic than the persistent symptms, and will prefer t delay treatment given a reasnable chance that spntaneus reslutin may ccur. Fr mst individuals there is n abslute medical indicatin fr either treatment chice and the parents' wn views shuld be decisive. T make an infrmed decisin the parents need t knw the success rates fr prbing cmpared with J. D. H. YOUNG ET AL. the rate f spntaneus reslutin as identified in this study, and t realise that all interventins carry an element f risk. Fr example, prbing a naslacrimal duct destined fr spntaneus reslutin might be assciated with lcal trauma inducing canalicular r duct stensis. lo In this study bleeding frm the punctum, which might signal such trauma, ccurred in 0% f all prbings. The parents will als wish t knw whether delay in treatment carries any risk. This has been suggested as a pssibility in the past, either by CNLDO predispsing t severe infectins r by chrnic infectin inducing permanent stensis f the lacrimal passages. 1l. l N serius infective cmplicatins ccurred in this study, r in ur study n children in the first year f life. 1 Hwever, a few cases f rbital cellulitis cnsidered secndary t lacrimal sac infectin are cited in the literature and the parents shuld be advised f this We cnsider that there is n valid evidence t cnfirm the suggestins that delay in prbing is detrimental t the cure rate. Katwitz and Welsh 1 fund a drp in the cure rate fr prbing frm 96% at ages 6-13 mnths t 33 % after years, and n this basis they advised prbing prir t 13 mnths f age. This analysis may require revisin in view f the high rate f spntaneus reslutin we have identified, which will generate an increased incidence f the mre severe bstructins in the later-prbed grups. In the present study 11 children were prbed after age years with a cure rate f 54%. Hwever, at 1 mnths f age they had been part f a grup f 50 infants, 35 f whm eventually shwed spntaneus reslutin, giving a ttal cure rate after the prbings f 8% (8% were lst t fllw-up after years). In a birth chrt study 96% f children riginally affected by CNLDO had had spntaneus reslutin f the cnditin by 1 mnths f age. l Extraplating this figure n the basis f the frequency f spntaneus reslutin fund in the present study, less than % f ducts may remain bstructed by age 4 mnths. If this grup culd be identified earlier, delay in their treatment culd be avided. Unfrtunately we were unable t demnstrate any majr crrelatin between cure rate and severity f symptms r signs, s there is at present n means f predicting utcme n an individual basis. The nly trend that did emerge was fr spntaneus reslutin in the small grup f infants with abnrmal FDDT results but whse parents reprted nly epiphra and nt discharge. We suggest prbing shuld be delayed until 4 mnths fr such patients. In cnclusin, we have emphasised the imprtance f the natural histry and parental chice in determining the requirement and timing fr any interventin in CNLDO. Sme previus studies l - 6, 14 have suggested that the medical advice t parents

7 MANAGEMENT OF CONGENITAL NASOLACRIMAL DUCT OBSTRUCTION 491 shuld be t delay prbing until after 1 mnths f age. We cnsider the evidence frm the present study wuld supprt a plicy f prbing at abut 1 mnths f age fr thse infants with severe signs and symptms f CNLDO. In less severe cases delay until 18 mnths is apprpriate, during which perid there is a 50% chance f spntaneus reslutin. In ur view there is n bjectin t further delay if the parents wish it and this shuld be specifically advised in infants with epiphra but minimal r n discharge. We thank the study secretary Mrs V. Brwn.The wrk was supprted by a grant frm the Speed-Pllck Trust. Key wrds: Cngenital naslacrimal duct bstructin, Prbing. Natural histry. REFERENCES 1. MacEwen CJ, Yung JDH. Epiphra during the first year f life. Eye 1991;5: Price HW. Dacrystensis. J Pediatr 1947;30: Paul TO. Medical management f cngenital naslacrimal duct bstructin. J Pediatr 1958;: Petersn RA, Rbb RM. The curse f cngenital bstructin f the nas-iacrimal duct. J Pediatr Ophthalml Strabismus 1978;15: Nelsn LB, Calhun JH, Menduke H. Medical management f cngenital naslacrimal duct bstructin. Ophthalmlgy 1985;9: Nucci P, et at. Cnservative management f naslacrimal duct bstructin. J Pediatr Ophthalml Strabismus 1989;6: MacEwen CJ, Yung JDH. The flurescein disappearance test: an evaluatin f its use in infants. J Pediatr Ophthalml Strabismus 1991 ;8: Katwitz la, Welsh MG. Timing f silastic tubing remval after intubatin fr cngenital naslacrimal duct bstructin. Ophthalmic Plast Recnstr Surg 1989;5: AI-Hussain H, Nasr AM. Silastic intubatin in cngenital naslacrimal duct bstructin. A study f 19 eyes. Ophthalml Plast Recnstr Surg 1993;9:3-7.. Lyn DB, et at. Canalicular stensis fllwing prbing fr cngenital naslacrimal duct bstructin. Ophthalmic Surg 1991;: Ffks 00. Dacrcystitis in infancy. Br J Ophthalml 196;46: Katwitz JA, Welsh MG. Timing f initial prbing and irrigatin in cngenital naslacrimal duct bstructin. Ophthalmlgy 1987;94: Nda S, Hayasaka S, Setgawa T. Cngenital naslacrimal duct bstructin in Japanese infants: its incidence and treatment with massage. J Pediatr Ophthalml Strabismus 1991 ;8: EI-Mansury J, et al. Results f late prbing fr cngenital naslacrimal duct bstructin. Ophthalmlgy 1986;93:5-4.

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