Pediatric Eye Disease Investigator Group (PEDIG)

Protocol: NLD1 - A Prospective Study of Primary Surgical Treatment of Nasolacrimal Duct Obstruction in Children Less Than Four Years Old
Status: Closed
Start Date: 02/01/2005
End Date: 09/30/2006
Clinical Trial ID: NCT00315289
Public Dataset:  Download


A Prospective Study of Primary Surgical Treatment of Nasolacrimal Duct Obstruction in Children Less Than Four Years Old

Protocol

Study Objectives:

The primary objective of the study is to report the success proportions of simple probing within different age groups of patients, particularly those under 2 years of age.

Secondary objectives are to obtain descriptive data regarding symptoms and quality of life in patients receiving simple probing.

Summary of Results:

The proportion of eyes treated successfully (no epiphora, mucous discharge or increased tear film present upon examination) was 78% overall and was 78% for the 421 eyes in children aged 6 to <12 months, 79% for the 419 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.

Eyes which were treatment successes had greater improvement in the symptom score than did treatment failures (mean improvement of 2.1 points vs. 0.75 points, P = <0.0001).

Patients who experienced treatment success in each eye operated (i.e. one eye for unilateral cases, both eyes for bilateral cases) showed greater improvement in quality of life score than did the patients who experienced treatment failure in any eye operated (mean improvement of 1.58 points vs. 0.50 points, P = <0.0001).

Conclusion:

In children 6 to <36 months of age, probing is a successful primary treatment of NLDO in about three-fourths of cases with no decline in treatment success with increasing age.

Too few patients aged 36-<48 months were enrolled to draw conclusions about the success of probing in this group.

Successful treatment improves symptoms and quality of life more than failed treatment.

 

Published:
  1. Pediatric Eye Disease Investigator Group. Primary treatment of nasolacrimal duct obstruction with probing in children younger than 4 years. Ophthalmology 2008;115:577-84.
  2. Pediatric Eye Disease Investigator Group. Primary treatment of nasolacrimal duct obstruction with nasolacrimal duct intubation in children younger than 4 years of age. J AAPOS 2008;12:445-50.
  3. Pediatric Eye Disease Investigator Group. Primary treatment of nasolacrimal duct obstruction with balloon catheter dilation in children younger than 4 years of age. J AAPOS 2008;12:451-5.

 



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