congenital nasolacrimal duct obstruction
Conditions
Interventions
blind probing group Perform surgery under local anesthesia. Either a bougie or a cannula is used as a probe to puncture the obstructed site by blind manipulation. After puncturing, the passage of wat
Sponsors
Japanese Society of Lacrimal Passage and Tear Dynamics
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients diagnosed with unilateral congenital nasolacrimal duct obstruction, accompanied by symptoms of epiphora or mucoid discharge, and whose surrogate (guardian) is willing to undergo initial surgical treatment. 2. Patients between the ages of 6 and 16 months whose surrogate (guardian) provides written consent for participation in this study.
Exclusion criteria
Exclusion criteria: 1. patients with congenital malformation syndrome, developmental delay, facial deformity, or facial abnormality 2. patients with perinatal abnormalities such as prematurity and low birth weight 3. patients with other diseases such as keratitis, which cause epiphora and mucoid discharge and are difficult to distinguish 4. patients with a history of surgery related to the lacrimal apparatus 5. patients with a history of previous trauma to the eyelid or face that may cause damage to the lacrimal duct 6. patients with a history of infection such as epidemic keratoconjunctivitis or eyelid herpes, which may cause abnormalities of the lacrimal duct 7. patients with lacrimal punctum obstruction or lacrimal fistula 8. patients with congenital dacryocele or acute dacryocystitis 9. other patients whom the physician in charge determines to be difficult to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of cure rates At 21-35 days postoperatively, the percentage of cases that are "cured" according to the "Criteria for Cure" is compared between the two groups. The cure rate is defined as (the number of cured cases)/(the number of cases in the Full Analysis Set). Comparison of improvement rates If there is a significant difference in the cure rate, the ratio of "improved, which is the sum of "cured" and "mildly improved, is compared between the two groups as a fixed-order test. The rate of improvement is defined as (the number of cases in which the criteria were "cured" and "improved")/(the number of cases in the Full Analysis Set). Analysis of the Primary Endpoints: For primary endpoint 1 (cure rate), a logistic regression analysis will be conducted using the allocation adjustment factor (age in months) as a covariate. The point estimate and 95% confidence interval of the odds ratio for cure in the endoscopy group relative to the bougie group will be calculated. A two-sided hypothesis test at a 5% significance level will be performed to assess whether the odds ratio is equal to 1. The hypothesis test for primary endpoint 2 will only be performed if this test yields statistically significant results. For primary endpoint 2 (improvement rate), a logistic regression analysis will likewise be conducted using the allocation adjustment factor (age in months) as a covariate. The point estimate and 95% confidence interval of the odds ratio for improvement in the endoscopy group relative to the bougie group will be calculated, and a two-sided hypothesis test at a 5% significance level will be conducted to evaluate whether the odds ratio is equal to 1. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of patient satisfaction: A satisfaction questionnaire is administered at the one-month postoperative visit. Satisfaction is rated on a 3-point scale of "satisfactory, normal, and unsatisfactory". Prevalence of dacryolith: The percentage (%) of dacryolith (stones in the lacrimal duct) confirmed in the lacrimal duct endoscopy group will be investigated. Safety endpoints: adverse events. Analysis of the Secondary Endpoints: For secondary endpoint 3, patient satisfaction, the proportion of patients who responded as "satisfied" will be compared between the two groups using Fisher's exact test. The significance level will be set at 5%. For secondary endpoint 4, the prevalence of dacryoliths (tear stones), the percentage will be calculated and evaluated descriptively. | — |
Countries
Japan
Contacts
Public ContactNozomi Matsumura
Kanagawa Children's Medical Center Department of Ophthalmology
Outcome results
None listed