A multicenter Randomized Controlled trial of surgical treatment for congenital nasolacrimal duct obstruction.

Not Applicable

• Conditions: congenital nasolacrimal duct obstruction

• Registration Number: JPRN-UMIN000050757
• Lead Sponsor: Japanese Society of Lacrimal Passage and Tear Dynamics

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-04-06
• Last Update Posted: 17 October 2023
• Study Completion: 2026-05-10

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 408

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
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.