Primary treatment of nasolacrimal duct obstruction with balloon catheter dilation in children...

Primary Treatment of Nasolacrimal Duct Obstruction with ProbingIn Children Less Than Four Years Old

Pediatric Eye Disease Investigator Group*

AbstractObjective—To report the outcome of nasolacrimal duct probing as the primary treatment ofcongenital nasolacrimal duct obstruction (NLDO) in children less than 4 years of age

Design—Prospective, non-randomized observational multicenter study (44 sites)

Participants—Nine hundred fifty-five eyes of 718 children aged 6 to <48 months at the time ofsurgery, with no prior nasolacrimal surgical procedure, and with at least one of the following clinicalsigns of NLDO present: epiphora, mucous discharge and/or increased tear lake.

Intervention—Probing of the nasolacrimal system of the affected eye

Main outcome measure—Treatment success was defined as no epiphora, mucous discharge orincreased tear lake present at the outcome visit one month after surgery.

Results—The proportion of eyes treated successfully was 78% (95% confidence interval (CI) =75% to 81%) overall and was 78% for the 421 eyes in children aged 6 to <12 months, 79% for the421 eyes in children aged 12 to <24 months, 79% for the 37 eyes in children aged 24 to <36 months,and 56% for the 11 eyes in children aged 36 to <48 months. The probability of treatment successwas lower in eyes operated in an office setting compared with in a surgical facility (adjusted relativerisk 0.88 [95% CI = 0.80 to 0.96]), with success reported in 72% (95% CI = 66% to 78%) of probingsperformed in an office and in 80% (95% CI = 77% to 84%) of probings performed in a facility. Theprobability of treatment success was also lower in eyes of patients with bilateral disease (adjustedrelative risk 0.88 [95% CI = 0.81 to 0.95]).

Conclusions—In children 6 to <36 months of age, probing is a successful primary treatment ofNLDO in about three-fourths of cases with no decline in treatment success with increasing age. Thestudy enrolled too few children aged 36–<48 months to allow a conclusion regarding the probabilityof treatment success in this age group.

Nasolacrimal duct obstruction (NLDO) is a common condition during the first year of life.Most cases resolve spontaneously or following lacrimal sac massage.1–4 For those childrenwhose blockage does not resolve, probing of the nasolacrimal duct is a widely-used surgicaltreatment. Most clinicians prefer to perform this procedure in infancy or early childhood. Inchildren younger than 18 months old, success rates of 77% to 97% have been reported.5–10These case series have largely been retrospective, used the surgeon for outcome assessment,had varied definitions of success, and/or were conducted in single centers.

Controversy remains regarding the optimal timing of the probing procedure. Because somereports have shown that a delay is associated with a poorer outcome,3, 9, 11, 12 some clinicians

Corresponding author: Michael X. Repka, M.D., c/o Jaeb Center for Health Research, 15310 Amberly Drive, Suite 350, Tampa, FL33647; Phone: (813) 975-8690, Fax: (813) 975-8761, E-mail: [email protected].*A partial list of the members of the Pediatric Eye Disease Investigator Group (PEDIG) appears at the end of this report. A complete listof participants is available at http://aaojournal.org.Financial Disclosure: none

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Published in final edited form as:Ophthalmology. 2008 March ; 115(3): 577–584.e3.

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would argue for treatment soon after diagnosis. Others have suggested that waiting for thepossibility of spontaneous resolution is not associated with an increase in failures and reducesthe overall number of procedures.13 A number of studies have found that probing is highlysuccessful and without an age-related decline in success until at least 4 years of age.5, 14However, other authors have countered that there is a lower success rate with advancing age.9, 11, 15 Determining whether there is a clinically significant age-related decline in successwould allow physicians and parents to better decide whether it is reasonable to wait for a periodof time for spontaneous resolution and have probing performed later if spontaneous resolutiondoes not occur.

Another controversy is related to the setting of surgery. In children younger than about oneyear of age, surgery may be performed either in the office with topical anesthesia and physicalrestraint or in a surgical facility under general anesthesia.8, 10 Surgeons who perform officeprobings generally recommend that surgery be performed by about one year of age, therebyallowing sufficient, yet safe restraint of the child without the need for general anesthesia.Surgeons who perform probings in a facility often wait until a target age allowing for thepossibility of spontaneous resolution.13

We conducted a large prospective non-randomized observational study of probing as primarysurgical treatment of congenital NLDO, enrolling children from 6 to <48 months of age inwhom a surgical procedure was planned. The timing of the procedure was determined by theclinician caring for the child. During the study of probing we also enrolled children whounderwent balloon catheter dilation or nasolacrimal duct intubation into separate observationalstudies. Herein, we report the outcomes for children who underwent probing as primarytreatment of NLDO.

MethodsThis study, supported through a cooperative agreement with the National Eye Institute of theNational Institutes of Health, was conducted by the Pediatric Eye Disease Investigator Group(PEDIG) at 45 clinical sites. Investigators were predominantly fellowship trained pediatricophthalmologists, although a few oculoplastic sub-specialists also participated. The protocoland Health Information Portability and Accountability Act of 1996-compliant informedconsent forms were approved by the respective institutional review boards. The parent orguardian of each study patient gave written informed consent.

The study included children aged 6 to <48 months who were planning to undergo a surgicalprocedure for the treatment of NLDO within the next 30 days. Major eligibility criteria includedonset of NLDO symptoms prior to 6 months chronological age; presence of at least one signof NLDO (epiphora, increased tear lake, and/or mucopurulent discharge in the absence of anupper respiratory infection or ocular surface irritation); no prior nasolacrimal duct surgeryincluding simple probing, nasolacrimal intubation, balloon catheter dilation, ordacryocystorhinostomy; and absence of Down syndrome. In addition children withcraniosynostosis, Goldenhar sequence, clefting syndromes, hemifacial microsomia or anymidline facial anomaly were excluded.

Enrollment and SurgeryAt the enrollment visit, each of three clinical signs of NLDO (epiphora, increased tear lake,and mucous discharge) was assessed by the surgeon and reported as either present or absent.A Dye Disappearance Test (DDT) without topical anesthesia was performed by a certifiedexaminer. After waiting 5 minutes the results were classified as either normal, abnormal, orindeterminate, based on a simplification of a scheme proposed by MacEwen and colleagues.16 Standard drawings of the DDT findings were used for comparison. In brief, no retained

Ophthalmology. Author manuscript; available in PMC 2009 March 1.

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fluorescein in the tear film or only a very thin meniscus of fluorescein-tinted tear wereconsidered normal results, while a thick meniscus of fluorescein-tinted tear was consideredabnormal. An indeterminate result was minimally increased tear film or retained fluoresceinin the tear. In addition, a parent completed a written questionnaire on symptoms and health-related quality of life.17

Surgery was scheduled within 30 days of enrollment. The procedure could be performed in theoffice or in a facility at the preference of the investigator and parents (i.e., hospital outpatientsurgical department or ambulatory surgical center). Surgery consisted of the dilation of at leastone lacrimal punctum and the passage of a nasolacrimal probe into the nasopharynx at leastonce. Probe selection was at investigator discretion. Patency was confirmed by touching theprobe in the nasopharynx with a second probe, by visualization of the probe beneath the inferiorturbinate, or by recovery of fluorescein-colored saline from the nasopharynx after irrigationthrough the nasolacrimal system. Infracture of the inferior turbinate was optional. The natureof the obstruction was classified by the clinician as simple or complex, with simple defined asa single obstruction which was easily passed during the probing procedure.

Follow Up ExaminationA follow-up visit was stipulated by the protocol to be performed 1 month (±1 week) from thedate of surgery. Before the child was examined, the child’s parent again completed thequestionnaire. Once the questionnaire was completed, a trained and certified examiner otherthan the operating surgeon evaluated the presence or absence of each of three clinical signs ofNLDO (epiphora, increased tear lake, and mucous discharge). The DDT was also performed.

At the time of surgery, parents were instructed to reschedule their child’s follow up visit if thechild was experiencing symptoms of an upper respiratory infection (URI). If a child presentedat the initial follow up visit with URI symptoms, the examination was completed; however, ifone or more clinical signs of NLDO were present, the child was scheduled to return 1–3 weekslater for an additional follow-up visit once the URI symptoms had resolved, with the resultsof this second follow-up visit being used for analysis. If the additional visit was not completed,the data from the completed follow-up visit were used for analysis.

Parental QuestionnaireA previously validated written parental NLDO questionnaire17 (available athttp://public.pedig.jaeb.org, accessed June 30, 2007) was used to assess symptoms and health-related quality of life (HRQL). The questionnaire consists of 31 statements to be answered ona 5-point Likert-type scale with values of always (4), often (3), sometimes (2), rarely (1) ornever (0). The 23 symptom-related items are eye specific and were therefore answeredseparately for the right and left eye in patients receiving bilateral surgery. The 8 HRQL itemsthat pertained to the child were answered once in each administration of the questionnaire.Summary scores for both the symptom and HRQL subscales ranged from 0 to 4 with a higherscore indicating worse symptoms and worse HRQL. The questionnaire was scored as describedin the initial validation study.17

Statistical AnalysisThe primary outcome was treatment success or failure based on an assessment of clinical signs.Success was defined as the absence of all three clinical signs: epiphora, increased tear lake,and mucous discharge. The proportion of eyes with treatment success based on clinical signsassessment was computed separately for patients aged 6 to <12 months, 12 to <24 months, 24to <36 months, and 36 to <48 months, as well as separately for patients with proceduresperformed either in an office or in a facility. Point estimates and 95% confidence intervals


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(CIs) were calculated using logistic regression with generalized estimating equations (GEE)to adjust for correlation between eyes of patients who had both eyes operated.18

The association of treatment success with age was assessed by estimating relative risks for agegroups using Poisson regression with GEE.19 Age was assessed in an unadjusted model andin an adjusted model including laterality (unilateral vs. bilateral), location of procedure (officevs. facility), and the symptom score from the questionnaire as a continuous variable. Theseanalyses were also repeated for a cohort limited to procedures performed in a facility, excludingthose performed in an office.

The association of treatment success with other baseline demographic, clinical, and surgicalfactors was assessed by estimating relative risks using Poisson regression with GEE.19 Eachfactor was assessed in an unadjusted model and in an adjusted model which included age (asa continuous variable), laterality (unilateral vs. bilateral), location of procedure (office vs.facility), and the symptom score from the questionnaire (as a continuous variable).

The association of treatment success with change in symptom score was assessed using analysisof covariance. The proportion of eyes with symptom score improving one point or more wascompared between treatment successes and treatment failures using logistic regression. Bothmodels included the baseline symptom score as a covariate and used GEE to adjust for thecorrelation between eyes of patients who had both eyes operated.

Patients who experienced treatment success in each operated eye (i.e., one eye for unilateralcases, both eyes for bilateral cases) were compared with patients who experienced failure inany operated eye using analysis of covariance for the change in quality of life score, and usinglogistic regression for the proportion of eyes with quality of life score improving one point ormore. Both models included the baseline quality of life score as a covariate.

An additional analysis was conducted in which success was defined as a normal DDT at theoutcome exam.

For the tests of association, with the number of covariates we assessed it is likely that aboutone observed association occurred by chance. All analyses were conducted using SAS version9.1. (SAS Institute Inc. Cary, NC).

ResultsBaseline Characteristics

Between February 2005 and April 2006, a probing was performed for NLDO in 955 eyes of718 patients at 44 clinical sites. Of the 63 investigators participating in the study, 8 (13%)investigators performed office probings exclusively, 50 (79%) investigators performed facilityprobings exclusively, and 5 (8%) investigators performed procedures in both settings. For all5 investigators who performed procedures in both settings, the majority of procedures (>80%)were performed in the office.

Patients ranged in age from 6.1 months to 45.5 months with a mean age of 13.6 months; 337(47%) patients were 6 to <12 months of age, 338 (47%) were 12 to <24 months, 35 (5%) were24 to <36 months and 8 (1%) were 36 to <48 months. Three hundred fifty six (50%) patientswere female and 579 (81%) were white. The onset of the NLDO was within the first month oflife for 600 (84%) patients and between 1 and 5 months of age for the other 118 (16%). Bilateraldisease was present in 237 (33%) patients. Surgery was performed in the office setting for 163(48%) patients aged 6 to <12 months of age, 34 (10) patients aged 12 to <24 months and fornone of the patients aged 24 months or older. At baseline, 768 (80%) of the 955 eyes had


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epiphora, 649 (68%) had mucous discharge, and 908 (95%) had increased tear lake. Thebaseline DDT was abnormal in 793 (83%) eyes and indeterminate in 138 (14%) eyes. Thebaseline symptom score as measured by the parental questionnaire was 2.6 ± 0.7 points on a0 to 4 scale, with 0 representing symptoms never being present and 4 representing symptomsalways being present. Additional baseline demographic, clinical, and surgery-relatedcharacteristics are reported in Table 1 (available at http://aaojournal.org).

ComplicationsSurgical and post-surgical complications were reported infrequently. There was one reportedepisode of laryngospasm which was managed without sequelae and one report of mild bleedingfrom a lacrimal punctum.

Visit CompletionThe outcome visit was completed by 672 (94%) of the 718 patients [900 (94%) of the 955eyes]. Thirty-one patients (4%) required an additional outcome visit because at the firstoutcome visit the patient had an URI and had one or more clinical signs present. Of these 31patients, 17 completed the additional visit. Fourteen patients (19 eyes) had no further followup and the assessment from their first outcome visit was used for all analyses.

Of the 672 patients completing the study, the visit used for analysis occurred within the protocolwindow (1 month ±1 week of surgery) for 508 (76%) patients. Forty-seven patients (7%)completed the visit early, 92 (14%) patients completed the visit within one month late, and 25(4%) completed the visit 2 to 5 months late. The clinical signs outcome was assessed by acertified examiner other than the investigator performing the surgery in 635 (94%) cases.

Characteristics of Patients Not Completing StudyBaseline characteristics for the 46 patients who did not complete the study compared with the672 patients who completed the study were as follows: mean age, 13.6 months vs. 13.6 months;mean baseline symptom score, 2.7 points vs. 2.6 points; mean baseline quality of life score,2.3 points vs. 2.0 points; mean duration of symptoms, 12.9 months vs. 13.1 months; proportionwho had surgery in the office as opposed to in a facility, 17% vs. 28%; and proportion havingbilateral procedures, 20% vs. 35%; respectively.

Primary Outcome and AgeTreatment was classified as successful when all three clinical signs of NLDO (epiphora,mucous discharge, and increased tear lake) were absent. Success was reported in 697 (78%[95% CI = 75% to 81%]) of the 900 eyes completing the study: 328 (78% [95% CI 74% to82%]) in the 421 eyes of patients aged 6 to <12 months, 326 (79% [95% CI = 74% to 83%])in the 421 eyes of patients aged 12 to <24 months, 37 (79% [95% CI = 65% to 88%]) in the47 eyes of patients aged 24 to <36 months, and 6 (56% [95% CI = 26% to 82%]) in the 11 eyesof patients aged 36 to <48 months (Figure 1). Compared with the 421 eyes from patients aged6 to <12 months at the time surgery, the adjusted relative risk of success was 0.94 (95% CI =0.87 to 1.02) for the 12 to <24 months group, 0.89 (95% CI = 0.74 to 1.07) for the 24 to <36months group, and 0.65 (95% CI = 0.37 to 1.15) for the 36 to <48 months group (Table 2).There was no meaningful difference between these risks by age group. A separate analysislimited to the 661 probings performed in a facility (i.e., excluding those performed in an office)found results similar to the overall analysis (see Table 2 footnote).

Association of Other Baseline Factors with Treatment OutcomeTable 3 shows the probability of treatment success according to various other baselinecharacteristics. The probability of treatment success was lower in eyes operated in an office


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setting (adjusted relative risk 0.88 [95% CI = 0.80 to 0.96] for office probings vs. facilityprobings), with success reported in 72% (95% CI = 66% to 78%) of probings performed in theoffice and in 80% (95% CI = 77% to 84%) of probings performed in a facility. The probabilityof treatment success was also lower in eyes with bilateral disease, with an increased tear lakepresent (regardless of whether any other signs were present), with two or more clinical signspresent at enrollment, and with higher (i.e., worse) symptom scores.

Dye Disappearance TestAt outcome, the proportion of eyes with a normal DDT result was 76% overall, 76% in the 418eyes from patients aged 6 to <12 months, 77% in the 420 eyes from patients aged 12 to <24months, 70% in the 45 eyes from patients aged 24 to <36 months, and 73% in the 11 eyes frompatients aged 36–<48 months (Table 4).

Symptom and Quality of Life Questionnaire OutcomeEyes which were treatment successes had greater improvement in the symptom score than didtreatment failures (mean improvement of 2.1 points vs. 0.79 points, P <0.0001) and were morelikely to have the symptom score improve 1 point or more (87% vs. 41%, P <0.0001). Meansymptom score at outcome was 0.49 points for treatment successes and 1.9 points for treatmentfailures.

For the 656 patients who had complete quality of life data at both enrollment and outcome, the492 patients who experienced treatment success in each eye operated (i.e., one eye for unilateralcases, both eyes for bilateral cases) showed greater improvement in quality of life score thandid the 164 patients who experienced treatment failure in any eye operated (mean improvementof 1.59 points vs. 0.48 points, P <0.0001) and were more likely to have quality of life scoreimprove 1 point or more (77% vs. 30%, P <0.0001). For the 658 patients who had completequality of life data at outcome, the mean quality of life score at outcome was 0.36 for the 493patients who experienced treatment success in each eye operated and 1.51 points for 165patients who experienced treatment failure in any eye.

DiscussionWe performed a prospective evaluation of nasolacrimal duct probing for NLDO in 900 eyesof 672 patients. Children were between 6 and 48 months of age at the time of their surgery andhad at least one sign of congenital NLDO (epiphora, mucous discharge, increased tear lake).The overall probability of success was 78%. This value may slightly underestimate the trueprobability because we included as treatment failures 19 eyes (2%) from 14 patients who hadURI and clinical signs of NLDO at their outcome exam but who did not return for the additionalfollow up visit mandated by the protocol. A few of these eyes might have been consideredsuccesses if they had returned for an assessment once the URI had cleared. Our overall successrate was similar to that reported by others,6, 7, 9, 20 better than the 69% reported by Katowitzand Welsh,9 though worse than the 92% reported by Robb.5 We also assessed the impact ofprobing on symptoms and quality of life of children with a parental NLDO questionnaire17and found that successful treatment improved symptoms and quality of life more than failedtreatment.

A major objective of this study was to evaluate the effect of age on the chance of success ofprobing. In patients aged 6 months to less than 36 months, we did not find that probing successwas related to patient age, either in our unadjusted data or after adjustment for the predictivefactors of laterality, surgical setting, and baseline symptom score. In the second year of life,we found a success rate of 79%. This was slightly worse than the 84.5% 11 to 89%12 thatothers have reported, but better than 69% reported by Katowitz and Welsh.9 We could


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adequately assess for an age effect on success of probing only in patients less than 36 monthsof age, because only 8 patients (11 eyes) in our cohort were from patients 36 to <48 monthsold. The literature includes a number of reports with conflicting conclusions with regard to anage effect. Some authors have found no significant age-related decline until at least 4 years ofage and beyond.5, 13, 14 A retrospective study by Robb found success rates of 89% in 108children aged 12 to 14 months, 97% in 63 children aged 15 to 17 months, 91% in 54 children18 to 23 months, 96% in 28 children 24 to 35 months and 93% in 27 children 36 months to 9years.5 However, others have found a clinically important decline in the success rate amongprogressively older age groups of young children.3, 9, 11, 12, 15 In a prospective studyKashkouli et al found a significant decline in success rate with increasing age with successoccurring in 89% of 99 children aged 13 to 24 months and in 72% of 39 children aged 25 to60 months.12

Demographic and clinical factors were analyzed for an impact on the success of probing. Wefound a significantly reduced chance of success when the procedure was performed in the office(72%) compared to when it was performed in a facility (80%). Perhaps the lower success withoffice probings might be due to a less robust procedure (e.g., probe passed only once) beingperformed in the office setting. Because our study was not randomized and because theinvestigators who performed office probings did so nearly exclusively, we cannot eliminatethe possibility that patient selection bias and/or an investigator effect may be important factorsunderlying the observed difference in success between the office and facility settings. Ourfinding was surprising and is at odds with the literature. Stager and colleagues found in aretrospective review of 2369 office probings,10 that the cure rate was 89% among 823 childrenaged 6 to 12 months and 87% among 119 children aged 12 months or older. In anotherretrospective review, Baker reported a success rate of 94% in 860 office probings.8

We found a reduced chance of success with probing among eyes of bilaterally affected children.Bilateral involvement might be a marker for more significant anatomical or physiologicalvariations in the nasolacrimal duct, mucous membrane physiology or the tear pumpmechanism, which may be more difficult to cure with probing. Alternatively, such childrenmight have allergic rhinitis, a condition which would not be cured with probing.

We also found reduced chances of success among eyes with worse baseline symptom scoresor with two or more clinical signs (i.e., epiphora, mucous discharge, increased tear lake) atbaseline. It is possible that the eyes with more symptoms and/or clinical signs had worse diseaseand thus were harder to cure. The lower chance of success among children with an increasedtear lake may be because children without an increased tear lake had either only very milddisease or even no disease and thus were easier to ‘cure.’

We studied the DDT as a secondary outcome measure. Success defined as normal drainage onthe DDT was found in about three quarters of patients, similar to the percentage when outcomewas assessed using clinical signs.

There are a number of strengths to our study. We utilized prospective data collection withoutcome assessment by a certified examiner other than the operating surgeon performed at auniform time interval following probing. We successfully recruited a large number of patientsand had low (6%) loss to follow up. We also utilized a large number of investigators whichmay increase the generalizability of our findings.

There are several limitations to our observational study. First, we enrolled only 35 two-yearold patients and only 8 three-year old patients. In addition to reducing the precision of ourestimates of success for these groups, the very low number of patients aged 36 to <48 monthsrequires our conclusion regarding the absence of a meaningful age effect to be restricted topatients less than 36 months old. Second, although we assessed the success of probing at various


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ages, we cannot address the question of optimal timing of surgery. To answer that questionwould require a study in which patients were randomized to either early surgery or a period ofobservation and later surgery if still indicated. Third, our interpretation of the finding thatoffice-based procedures had a lower chance of success than facility-based procedures is limitedbecause any potential investigator effect could not be separated from the setting effect. Fourth,we were unable to evaluate whether confirmation of patency was related to chance of successbecause of the way the data were collected. Patency not confirmed could have had severalmeanings--that patency was confirmed but by another non-protocol method (as was the casein several patients), that patency was not achieved, or that no attempt had been made to confirmpatency. Fifth, we are also unable to comment on the role for inferior turbinate infracture as itwas rarely performed in our study population. Lastly, this study was not population-based andtherefore might not be representative of the overall population of children who undergo surgeryfor congenital NLDO.

In summary, probing as a treatment of NLDO in children 6 to <36 months of age has an overallsuccess rate of 78%. There was no decline in success with age up to 36 months. Based on ourdata, we believe that probing should be considered an appropriate initial treatment forcongenital NLDO in children younger than three years of age.

The Pediatric Eye Disease Investigator GroupWriting Committee

Lead authors: Michael X. Repka, M.D.; Danielle L. Chandler, M.S.P.H.; Additional writingcommittee members (alphabetical): Roy W. Beck, M.D., Ph.D.; Eric R. Crouch III, M.D.; SeanDonahue, M.D., Ph.D.; Jonathan M. Holmes, B.M., B.Ch., Katherine Lee, M.D., Ph.D.; B.Michele Melia, Sc.M; Graham E. Quinn, M.D., M.S.C.E.; Nick A. Sala, D.O.; Susan Schloff,M.D.; David I. Silbert, M.D.; David K. Wallace, M.D., M.P.H.

Clinical Sites that Participated in this ProtocolSites are listed in order by number of patients enrolled into the study. Investigators for eachsite are listed below.

Erie, PA - Pediatric Ophthalmology of ErieNicholas A. Sala

Nashville, TN - Vanderbilt Eye CenterSean Donahue; David G. Morrison

Cranberry TWP, PA - Everett and Hurite Ophthalmic AssociationDarren L. Hoover

Boise, ID - Katherine Ann Lee, M.D., PAKatherine A. Lee

Norfolk, VA - Eastern Virginia Medical SchoolEarl R. Crouch, Jr.; Eric R. Crouch III

South Charleston, WV - Children’s Eye Care & Adult Strabismus SurgeryDeborah L. Klimek


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Dallas, TX - UT Southwestern Medical CenterDavid R. Weakley, Jr.; Kamel M. Itani

Saint Paul, MN - Associated Eye CareSusan Schloff; Ann Marie Hickson

Columbus, OH - Pediatric Ophthalmology Associates, IncDon L. Bremer; Cybil M. Bean; Richard P. Golden; Mary Lou McGregor; Gary L. Rogers

Providence, RI - Pediatric Ophthalmology and Strabismus AssociatesDavid Robbins Tien

Anchorage, AK - Ophthalmic AssociatesRobert W. Arnold

Albuquerque, NM - Goldblum Family Eye Care Center, P.CTodd A. Goldblum

Chicago Ridge, IL - The Eye Specialists Center, L.L.CBenjamin H. Ticho; Alexander J. Khammar

Wilmette, IL - Pediatric Eye AssociatesDeborah R. Fishman; Lisa C. Verderber

Lancaster, PA - Family Eye GroupDavid I. Silbert; Don D. Blackburn; Troy J. Hosey; Eric L. Singman

Colorado Springs, CO - The Children’s Eye CenterDave H. Lee; Nieca D. Caltrider

Springfield, MO - St. John’s Clinic - Eye SpecialistsScott Atkinson

Houston, TX – Baylor College of Medicine and Texas Children’s HospitalEvelyn A. Paysse; David K. Coats; Jane Covington Edmond; Paul G. Steinkuller; KimberlyG. Yen

Waterbury, CT - Eye Care Group, PCAndrew J. Levada; Jonathan E. Silbert

Calgary, - Alberta Children’s HospitalWilliam F. Astle; Michael E. Ashenhurst; Anna L. Ells; Vivian E. Hill; Femida Kherani;Kenneth G. Romanchuk

West Des Moines, IA - Wolfe ClinicDonny W. Suh


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Dallas, TX - Pediatric Ophthalmology, P.ADavid R. Stager, Sr.; David R. Stager Jr.

Milford, CT - Eye Physicians & Surgeons, PCDarron A. Bacal

Philadelphia, PA - Children’s Hospital of PhiladelphiaBrian J. Forbes; James A. Katowitz; Monte D. Mills; Graham E. Quinn

Oklahoma City, OK - Dean A. McGee Eye Institute, University of OklahomaLucas Trigler; R. Michael Siatkowski

Sacramento, CA - The Permanente Medical GroupJames B. Ruben

St. Louis, MO - Cardinal Glennon Children’s HospitalOscar A. Cruz; Bradley V. Davitt

Durham, NC - North Carolina Eye, Ear, Nose & ThroatJoan Therese Roberts

Minneapolis, MN - University of MinnesotaC. Gail Summers; Erick D. Bothun; Stephen P. Christiansen

Rochester, NY - University of Rochester Eye InstituteMatthew D. Gearinger

Baltimore, MD - Greater Baltimore Medical CenterMary Louise Z. Collins

Willoughby, OH - Ophthalmology Consultants, IncBernard D. Perla

Atlanta, GA - The Emory Eye CenterScott R. Lambert; Amy K. Hutchinson

Brighton, MI - University of MichiganErika M. Levin

Ann Arbor, MI - University of MichiganMonte A. Del Monte; Maya Eibschitz-Tsimhoni

Denver, CO - University of Colorado Health Sciences CenterRebecca Sands Braverman; Theodore H. Curtis; Arlene V. Drack

Pinehurst, NC - Family Eye Care of the CarolinasMichael John Bartiss


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Portland, OR - Casey Eye InstituteDavid T. Wheeler; John D. Ng; Ann U. Stout

Baltimore, MD - Wilmer InstituteMichael X. Repka

Canton, MI - University of MichiganMaya Eibschitz-Tsimhoni; Erika M. Levin

Grand Rapids, MI - Pediatric Ophthalmology, P.CPatrick J. Droste; Robert J. Peters

Madison, WI - University of Wisconsin, Dept. of Ophthalmology & Visual SciencesYasmin S. Bradfield; Thomas D. France

Rochester, MN - Mayo ClinicJonathan M. Holmes; Brian G. Mohney

Rockville, MD - Stephen R. Glaser, M.D., P.CStephen R. Glaser; Allison A. Jensen

Fall River, MA - Center for Eye Health Truesdale ClinicJohn P. Donahue

Acknowledgements

Funding/Support: Supported through a cooperative agreement from the National Eye Institute EY11751

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obstruction. Ophthalmology 1987;94:698–705. [PubMed: 3627719]10. Stager D, Baker JD, Frey T, et al. Office probing of congenital nasolacrimal duct obstruction.

Ophthalmic Surg 1992;23:482–4. [PubMed: 1407947]11. Kashkouli MB, Kassaee A, Tabatabaee Z. Initial nasolacrimal duct probing in children under age 5:

cure rate and factors affecting success. J AAPOS 2002;6:360–3. [PubMed: 12506276]


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12. Kashkouli MB, Beigi B, Parvaresh MM, et al. Late and very late initial probing for congenitalnasolacrimal duct obstruction: what is the cause of failure? Br J Ophthalmol 2003;87:1151–3.[PubMed: 12928286]

13. El-Mansoury J, Calhoun JH, Nelson LB, Harley RD. Results of late probing for congenitalnasolacrimal duct obstruction. Ophthalmology 1986;93:1052–4. [PubMed: 3763154]

14. Kushner BJ. The management of nasolacrimal duct obstruction in children between 18 months and4 years old. J AAPOS 1998;2:57–60. [PubMed: 10532369]

15. Mannor GE, Rose GE, Frimpong-Ansah K, Ezra E. Factors affecting the success of nasolacrimal ductprobing for congenital nasolacrimal duct obstruction. Am J Ophthalmol 1999;127:616–7. [PubMed:10334364]

16. MacEwen CJ, Young JD. The fluorescein disappearance test (FDT): an evaluation of its use in infants.J Pediatr Ophthalmol Strabismus 1991;28:302–5. [PubMed: 1757852]

17. Holmes JM, Leske DA, Cole SR, et al. A symptom survey and quality of life questionnaire forNasolacrimal Duct Obstruction in Children. Ophthalmology 2006;113:1675–80. [PubMed:16828516]

18. Zeger SL, Liang K, Albert PS. Models for longitudinal data: A generalized estimating equationapproach. Biometrics 1988;44:1049–60. [PubMed: 3233245]

19. Zou G. A modified Poisson regression approach to prospective studies with binary data. Am JEpidemiol 2004;59:702–6. [PubMed: 15033648]

20. Ghuman T, Gonzales C, Mazow MM. Treatment of congenital nasolacrimal duct obstruction. AmOrthoptic J 1999;49:163–8.


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Figure 1.Treatment Success by Age at ProbingTreatment success is defined as no epiphora, mucous discharge, or increased tear lake presentat the outcome exam. Both point estimates and 95% confidence intervals are adjusted to accountfor intereye correlation in bilateral cases.


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Table 1Baseline Characteristics of Study Cohort

Age

6 to <12 Months 12 to <24Months

24 to <36 Months 36 to <48 Months

Patient-Level Characteristics N=337 N=338 N=35 N=8

Gender: Female, N % 177 (53) 164 (49) 17 (49) 4 (50)

Race/ethnicity, N % White 266 (79) 286 (85) 23 (66) 4 (50) African-American 22 (7) 19 (6) 6 (17) 2 (25) Hispanic or Latino 30 (9) 15 (4) 4 (11) 2 (25) Other 19 (6) 18 (5) 2 (6) 0 (0)

Age at onset in monthsa N % Birth - <1 289 (86) 278 (82) 27 (77) 6 (75) 1 to <6 48 (14) 60 (18) 8 (23) 2 (25)

Duration of symptoms in monthsa Mean (SD) 9.2 (1.8) 15.0 (3.0) 26.8 (3.2) 40.4 (4.6) Range 2.2 to 12.0 6.7 to 23.9 21.9 to 33.7 31.2 to 45.5

Quality of life score from questionnaireb Mean (SD) 2.0 (0.8) 2.0 (0.7) 1.6 (0.8) 1.8 (0.7) Range 0.3 to 4.0 0.1 to 3.9 0.3 to 3.6 1.0 to 3.1

Previous treatment with topical antibiotics, N% Yes 221 (66) 225 (67) 20 (57) 3 (38) No 102 (30) 101 (30) 14 (40) 5 (63) Not known or other 14 (4) 12 (4) 1 (3) 0 (0)

Previous treatment with nasolacrimal massage,N % Yes 259 (77) 219 (65) 25 (71) 3 (38) No 66 (20) 102 (30) 6 (17) 3 (38) Not known or other 12 (4) 17 (5) 4 (11) 2 (25)

Laterality, N % Unilateral 229 (68) 225 (67) 18 (51) 5 (63) Bilateralc 108 (32) 113 (33) 17 (49) 3 (38)

Location of surgery, N % Office 163 (48) 34 (10) 0 (0) 0 (0) Ambulatory surgery center 56 (17) 100 (30) 8 (23) 2 (25) Hospital 118 (35) 204 (60) 27 (77) 6 (75)

Type of anesthesia, N % None or only topical anesthesia 163 (48) 34 (10) 0 (0) 0 (0) Conscious sedation 1 (<1) 2 (1) 0 (0) 0 (0) General anesthesia 173 (51) 302 (89) 35 (100) 8 (100)

Classification of obstruction, N % Simple 271 (80) 256 (76) 28 (80) 7 (88) Complex 51 (15) 62 (18) 3 (9) 0 (0) Simple/Complex 15 (4) 20 (6) 4 (11) 1 (12)

Inferior turbinate infracture, N % Yes 17 (5) 22 (7) 1 (3) 1 (13) No 317 (94) 314 (93) 34 (97) 7 (88) Yes/No 3 (1) 2 (1) 0 (0) 0 (0)

Patency confirmed,d N % 249 (74) 315 (93) 35 (100) 7 (88)

Eye-Level Characteristics N=445 N=450 N=49 N=11

Epiphora present, N % 346 (78) 371 (82) 41 (84) 10 (91)

Mucous discharge present, N % 334 (75) 276 (61) 36 (73) 3 (27)

Increased tear lake present, N % 427 (96) 423 (94) 48 (98) 10 (91)

Number of clinical signs,e N %


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Age

6 to <12 Months 12 to <24Months

24 to <36 Months 36 to <48 Months

Patient-Level Characteristics N=337 N=338 N=35 N=8

1 61 (14) 62 (14) 4 (8) 1(9)

2 106 (24) 156 (35) 14 (29) 8 (73)

3 278 (62) 232 (52) 31 (63) 2 (18)

Dye Disappearance Test, N %

Normal 9 (2) 13 (3) 2 (4) 0 (0)

Indeterminate 57 (13) 71 (16) 9 (18) 1 (9)

Abnormal 379 (85) 366 (81) 38 (78) 10 (91)

Symptom Score from Questionnairef

Mean (SD) 2.6 (0.7) 2.6 (0.7) 2.5 (0.8) 2.4 (0.5)

Range 0.3 to 4.0 0.3 to 4.0 0.5 to 3.8 1.7 (3.3)aRefers to the average for both eyes for patients with bilateral NLDO.

bThe quality of life score is the average of the responses for the quality of life subscale items. Each item’s response is on a 5-point Likert scale as follows:

0=never 1=rarely, 2=sometimes, 3=often, 4=always, therefore the higher the quality of life score, the worse the patient’s quality of life was reported tobe. Quality of life data are missing for 2 patients: 1 in the 6 to <12 months age group and 1 in the 12 to <24 months age group.

cOne patient in the 12 to <24 month old group and three patients in the 24 to <36 month old group had simple probing performed on one eye and intubation

performed on the other eye. Data from the eye undergoing intubation is not analyzed herein.

dRefers to patency confirmed by any of the following methods: metal on metal; fluorescein irrigation and recovery from nose, or visualization. Failure

to confirm patency could mean either 1) that patency was confirmed but by another method, or 2) that patency was not achieved, or 3) that no attempt hadbeen made to confirm patency.

eClinical signs refers to epiphora, mucous discharge or increased tear lake.

fThe symptom score is the average of the responses for the symptoms subscale items. Each item’s response is on a 5-point Likert scale as follows: 0=never

1=rarely, 2=sometimes, 3=often, 4=always, therefore the higher the symptom score, the more frequent the patient’s symptoms were reported to be.Symptom data are missing for 14 eyes: 5 in the 6 to <12 months age group, 7 in the 12 to <24 months age group, and 2 in the 24 to <36 months age group.

SD= standard deviation


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Table 2Clinical Signs Outcome Success According to Age at Surgery (N= 900 Eyes)

Age at surgery N Success N (%)Relative Risk for Successa and 95% Confidence Interval

Unadjusted Adjusted6 to <12 months 421 328 (78) ----- -----12 to <24 months 421 326 (79) 1.01 (0.93 to 1.09) 0.94 (0.87 to 1.02)24 to <36 months 47 37 (79) 0.98 (0.82 to 1.16) 0.89 (0.74 to 1.07)36 to <48 months 11 6 (56) 0.71 (0.40 to 1.26) 0.65 (0.37 to 1.15)aReference level is 6 to <12 months of age. Unadjusted relative risks and 95% confidence intervals are from Poisson regression models using categorical

age as the only covariate. Adjusted relative risks and 95% confidence intervals are from Poisson regression models which include categorical age, laterality(unilateral vs. bilateral), location of procedure (office vs. facility), and the symptom score from the questionnaire as a continuous variable. All modelsused generalized estimating equations to account for the intereye correlation between eyes from bilateral cases. When the same analysis is limited to the661 probings performed in a facility (as opposed to in an office), compared to 6 to <12 month the adjusted relative risks are 0.92 (0.85 to 1.00) for 12 to<24 months, 0.88 (0.73 to 1.06) for 24 to <36 months, and 0.64 (0.36 to 1.14) for 36 to <48 months.


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Ta

ble

3C

linic

al S

igns

Out

com

e Su

cces

s Acc

ordi

ng to

Bas

elin

e C

hara

cter

istic

s (N

=900

Eye

s)

Bas

elin

e C

hara

cter

istic

All

Eye

s (N

=900

)R

elat

ive

Ris

k fo

r Su

cces

sa and

95%

Con

fiden

ce In

terv

al

NSu

cces

s N (%

)U

nadj

uste

dA

djus

ted

Tota

l90

069

7 (7

8)--

---

----

-

Gen

der

Fe

mal

e46

035

0 (7

6)0.

96 (0

.89

to 1

.03)

0.95

(0.8

9 to

1.0

3)

Mal

e44

034

7 (7

9)--

---

----

-

Rac

e/et

hnic

ity

Whi

te18

113

3 (7

3)--

---

----

-

Non

-whi

te71

956

4 (7

8)1.

06 (0

.96

to 1

.17)

1.05

(0.9

5 to

1.1

7)

Age

at o

nset

, in

mon

ths

B

irth

- <1

mon

th14

111

1 (7

9)0.

98 (0

.89

to 1

.08)

1.00

(0.9

0 to

1.1

0)

1 to

<6

759

586

(77)

----

---

---

Late

ralit

y

Uni

late

ral

440

359

(82)

----

---

---

B

ilate

ralb

460

338

(73)

0.90

(0.8

3 to

0.9

7)0.

88 (0

.81

to 0

.95)

Epip

hora

Pr

esen

t72

155

1 (7

6)0.

92 (0

.85

to 1

.01)

0.94

(0.8

6 to

1.0

2)

Abs

ent

179

146

(82)

----

---

---

Muc

ous d

isch

arge

Pr

esen

t60

947

8 (7

8)1.

00 (0

.93

to 1

.08)

1.01

(0.9

3 to

1.0

9)

Abs

ent

291

219

(75)

----

---

---

Incr

ease

d te

ar la

ke

Pres

ent

861

660

(77)

0.85

(0.7

7 to

0.9

4)0.

88 (0

.79

to 0

.99)

A

bsen

t39

37 (9

5)--

---

----

-

Num

ber o

f clin

ical

sign

sc

111

810

2 (8

6)--

---

----

-

2 or

378

259

5 (7

6)0.

88 (0

.81

to 0

.94)

0.89

(0.8

2 to

0.9

6)

Bas

elin

e D

ye D

isap

pear

ance

Tes

t

Nor

mal

2315

(65)

0.95

( 0.

73 to

1.2

3)0.

91 (

0.70

to 1

.19)

In

dete

rmin

ate

131

111

(85)

1.11

(1.0

3 to

1.2

1)1.

10 (1

.02

to 1

.20)

A

bnor

mal

746

571

(77)

----

---

---

Bas

elin

e sy

mpt

om sc

ored

0

to <

1.0

poin

ts23

20 (8

7)--

---

----

-

1.0

to <

2.0

poin

ts13

410

5 (7

8)0.

89 (0

.77

to 1

.04)

0.88

(0.7

5 to

1.0

2)

2.0

to <

3.0

poin

ts40

531

8 (7

9)0.

90 (

0.78

to 1

.03)

0.88

(0.7

6 to

1.0

1)

3.0

to ≤

4.00

poi

nts

326

245

(75)

0.84

(0.7

3 to

0.9

7)0.

82 (0

.71

to 0

.94)

Loca

tion

of su

rger

y

Off

ice

239

167

(72)

0.89

(0.8

1 to

0.9

8)0.

88 (

0.80

to 0

.96)

Fa

cilit

y66

153

0 (8

0)--

---

----

-

Obs

truct

ion

C

ompl

ex18

414

1 (7

7)0.

99 (0

.90

to 1

.08)

1.01

(0.9

2 to

1.1

1)

Sim

ple

716

556

(78)

----

---

---


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Bas

elin

e C

hara

cter

istic

All

Eye

s (N

=900

)R

elat

ive

Ris

k fo

r Su

cces

sa and

95%

Con

fiden

ce In

terv

al

NSu

cces

s N (%

)U

nadj

uste

dA

djus

ted

Infe

rior t

urbi

nate

infr

actu

re

Yes

5946

(78)

1.00

(0.8

7 to

1.1

6)0.

96 (0

.83

to 1

.11)

N

o84

165

1 (7

7)--

---

----

-a R

elat

ive

risks

are

for e

yes o

vera

ll (r

egar

dles

s of a

ge g

roup

) and

refe

r to

a co

mpa

rison

of r

isks

bet

wee

n th

e sp

ecifi

ed le

vel v

s. th

e re

fere

nce

leve

l. R

efer

ence

leve

l is i

ndic

ated

by

----

. Una

djus

ted

rela

tive

risks

and

95%

con

fiden

ce in

terv

als a

re fr

om P

oiss

on re

gres

sion

mod

els u

sing

the

fact

or o

f int

eres

t as t

he o

nly

cova

riate

. Adj

uste

d re

lativ

e ris

ks a

nd 9

5% c

onfid

ence

inte

rval

s are

from

Poi

sson

regr

essi

onm

odel

s whi

ch in

clud

e co

ntin

uous

age

as a

con

tinuo

us v

aria

ble,

late

ralit

y (u

nila

tera

l vs.

bila

tera

l), lo

catio

n of

pro

cedu

re (o

ffic

e vs

. fac

ility

), th

e sy

mpt

om sc

ore

from

the

ques

tionn

aire

as a

con

tinuo

usva

riabl

e, a

nd th

e fa

ctor

of i

nter

est.

All

mod

els u

sed

gene

raliz

ed e

stim

atin

g eq

uatio

ns to

acc

ount

for t

he in

tere

ye c

orre

latio

n be

twee

n ey

es fr

om b

ilate

ral c

ases

.

b Four

pat

ient

s had

sim

ple

prob

ing

perf

orm

ed o

n on

e ey

e an

d in

tuba

tion

perf

orm

ed o

n th

e ot

her e

ye. D

ata

from

the

eye

whi

ch re

ceiv

ed in

tuba

tion

is n

ot a

naly

zed

here

in.

c Clin

ical

sign

s are

epi

phor

a, m

ucou

s dis

char

ge a

nd in

crea

sed

tear

lake

.

d Rel

ativ

e ris

k pe

r add

ition

al p

oint

of s

ympt

om sc

ore

is 0

.94

(0.9

0 to

0.9

8) fr

om a

n un

adju

sted

mod

el a

nd 0

.93

(0.8

9 to

0.9

8) fr

om a

n ad

just

ed m

odel

. Tw

elve

eye

s are

mis

sing

sym

ptom

dat

a. It

ems #

1th

roug

h #7

on

the

naso

lacr

imal

duc

t que

stio

nnai

re re

late

to sy

mpt

oms.

Each

item

’s re

spon

se is

on

a 5-

poin

t Lik

ert s

cale

as f

ollo

ws:

0=n

ever

1=r

arel

y, 2

=som

etim

es, 3

=ofte

n, 4

=alw

ays.

The

sym

ptom

scor

e is

the

aver

age

of th

e 18

item

s whi

ch re

late

to sy

mpt

oms.

The

sym

ptom

scor

e is

on

a 0

to 4

scal

e--th

e hi

gher

the

sym

ptom

scor

e, th

e m

ore

freq

uent

the

patie

nt’s

sym

ptom

s was

repo

rted

to b

e.


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Table 4Dye Disappearance Test (DDT) Outcome (N=895)a

AgeDDT Results 6 to <12 Months (N=418) 12 to <24 Months

(N=420)24 to <36 Months (N=46) 36 to <48 Months (N=11)

Normal 318 (76) 325 (77) 32 (70) 8 (73)Indeterminate 39 (9) 46 (11) 10 (22) 2 (18)Abnormal 61 (15) 49 (12) 4 (9) 1 (9)aFive eyes are missing DDT outcome data: 3 in the 6 to <12 months group, 1 in the 12 to <24 months group, and 1 in the 24 to <36 months group.


Primary treatment of nasolacrimal duct obstruction with balloon catheter dilation in children...

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