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Lacrimal sac massage for congenital nasolacrimal duct obstruction: a multi-center randomized controlled trial

Lacrimal sac massage for congenital nasolacrimal duct obstruction: a multi-center randomized controlled trial - Lacrimal sac massage for congenital nasolacrimal duct obstruction: a multi-center RCT

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000032840
Enrollment
105
Registered
2018-06-01
Start date
2018-06-04
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congenital nasolacrimal duct obstruction

Interventions

Lacrimal sac massage twice a day (10 times each) by trained family with antibiotic eye drops three times a day Antibiotic eye drops three times a day

Sponsors

Department of Ophthalmology, Yokohama City University
Lead Sponsor
Kanagawa Children&#39
Collaborator
s Medical Center
Collaborator

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: (1) Patients from three months to twelve months who are diagnosed with congenital nasolacrimal duct obstruction. (2) Patients whose legally acceptable representative provided voluntary written consent for participation in this study

Exclusion criteria

Exclusion criteria: 1. Patients with congenital malformation, mental retardation, and facial anomalies. 2. Patients who have had a history of perinatal abnormality. 3. Patients with diseases such as keratitis and epiblepharon that may lead epiphora and eye discharge. 4. Patients who have had a history of surgery on lacrimal apparatus. 5. Patients who have had a history of facial injury that may affect lacrimal duct. 6.Patients who have had a history of infectious disease such as epidemic keratoconjunctivitis and herpes palpebrae that may lead lacrimal duct abnormality. 7. Patients with atresia puncti lacrimalis or lacrimal fistula. 8.Patients with congenital dacryocystocele or acute dacryocystitis. 9. Patients with severe blepharitis. 10. Patients who are considered inadequate to participate in this study by the medical doctor.

Design outcomes

Primary

MeasureTime frame
Cure rate at 1 month

Secondary

MeasureTime frame
Duration of treatment until cure (up to 3 month), Number of lacrimal sac massage until cure, drop-out rate, rate of surgical intervention, and safety

Countries

Japan

Contacts

Public ContactMasaki Takeuchi

Yokohama City University Ophthalmology

takeuchi@yokohama-cu.ac.jp0457872800

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026