Congenital Nasolacrimal Duct Obstruction Clinical Trial
— NonOfficial title:
Endoscopy Assisted Probing Versus Simple Probing in Patients With Primary Congenital Nasolacrimal Duct Obstruction: A Randomized Clinical Trial
Verified date | March 2019 |
Source | Tehran University of Medical Sciences |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this study is to compare results of endoscopy assisted nasolacrimal probing with
the standard simple probing in cases with congenital nasolacrimal duct obstruction .
Furthermore, investigators will identify associated anatomical anomalies. Investigators
believe results of this study can be valuable in better understanding of this disease and
provide a high evidence level necessary to propose a classification and management algorithm.
Children with symptoms of unilateral or bilateral congenital nasolacrimal duct obstruction,
no past surgical management, with one or more of the below criteria will be included:
1. Non-resolving symptoms of epiphora and/or discharge.
2. Congenital dacryocele not resolved after 1 week of lacrimal sac massage, and topical
antibiotics.
3. As soon as subsidence of acute dacryocystitis. Parents will be asked about symptoms and
patients will undergo lacrimal tests before and after operation in one week, one month
and 3months based on a special record form. Patients will be randomly assigned to
"simple probing" group or "endoscopy assisted probing" group.
All operations will be performed in operative theater and under general anesthesia. Pre- and
post-operative examinations will be performed in plastic clinic in Farabi hospital.
Status | Active, not recruiting |
Enrollment | 320 |
Est. completion date | July 1, 2020 |
Est. primary completion date | February 1, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A to 6 Years |
Eligibility |
Inclusion Criteria: 1. age: 3 weeks<Age<6 years 2. epiphora or discharge since birth or within 8 weeks after birth Exclusion Criteria: 1. Follow up less than 3 months 2. Epiphora secondary to etiologies than congenital naso-lacrimal duct obstruction such as puncta/canalicular aplasia/dysgenesis;midfacial anomalies; congenital eyelid malposition;epiblepharon; trichiasis; congenital glaucoma, tumors; blepharitis; trauma Treatment success: defined success absence of epiphora/lacrimation and discharge 6 months after intervention. |
Country | Name | City | State |
---|---|---|---|
Iran, Islamic Republic of | Farzad Pakdel | Tehran |
Lead Sponsor | Collaborator |
---|---|
Tehran University of Medical Sciences |
Iran, Islamic Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | success rate | absence of epiphora and discharge and negative dye disappearance test | 6 months | |
Secondary | Incidence of Treatment-Emergent Adverse Events | Incidence of complications related to the treatment including epistaxis, nasal stuffiness, injury to the nasolacrimal system or the eye, canalicular stenosis, keratopathy, nasal mucosa scar, synechia, tightening of inferior meatus (not reported at the time first intervention) to be described in those who need re-probing and nasal endoscopy. | 6 month |
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