Congenital Nasolacrimal Duct Obstruction results from discanalization of distal end part of duct, called"Hasner valve". The possibility of spontaneous recovery is very high during the first year of life. The standard procedure for the treatment of obstruction is nasolacrimal duct probing and irrigation, which is performed in the persistence of epiphora and discharge up to the age of 12months. Repeatation of nasolacrimal duct probing, nasolacrimal intubation and balloon dacryoplasty are alternate surgical techniques, in the cases of persistent, symptomatic cases. The project aims to evaluate the results of a Single tract of nasolacrimal intubation in the Congenital nasolacrimal duct obstruction as a primary treatment . All children with persistent symptoms of tearing and nasolacrimal duct obstructionat the range of 12-23 months of age, will be a candidate for nasolacrimal duct probing. They will enter the study if the irrigation is hard to be done. After by they will be intubated with Monaca- Crawford stent. The exclusion criteria include: history of lacrimal duct system trauma, previous lacrimal duct surgery or intubation, presence of Down syndrome, craniofacial anomalies, and follow up less than 6 months after surgery. The target sample number will be 70 eyes. The stent will be removed 3 months. Lack of tearing and discharge at the end of 6 months post operation period will be considered as a successful result.
General information
Acronym
CNLDO-Congenital Nasolacrimal Duct Obstruction
IRCT registration information
IRCT registration number:IRCT201208074580N3
Registration date:2014-07-22, 1393/04/31
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-07-22, 1393/04/31
Registrant information
Name
Dima Andalib
Name of organization / entity
Nikookary eye hospital, Tabriz Univesity of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1655 1332
Email address
andalibd@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology of Tabriz University of Medical sciences
Expected recruitment start date
2013-06-20, 1392/03/30
Expected recruitment end date
2014-09-21, 1393/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of success rate of primary monocanalicular intubation for Congenital Nasolacrimal Duct Obstruction in the cases of difficult irrigation
Public title
Evaluation of success rate of primary monocanalicular intubation for Congenital Nasolacrimal Duct Obstruction in the cases of difficult irrigation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria;1- Age: 12-23 months of age 2- Chief complaint: epiphora and discharge since born 3-Difficult irrigation during probing 4-Informed consent of parents . Exclusion criteria: 1– Previous lacrimal duct of tear duct surgery or nasolacrimal duct intubation 2- Presence of Down syndrome 3- Proximal part of lacrimal system anomalies such as punctual agenesis 4 - History of lacrimal duct system trauma 5- Craniofacial anomalies 6 – Follow up less than 6 months after surgery
Age
From 12 months old to 1 year old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Comittee off Tabriz University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, central department No 2, Tabriz University of Medical Sciences, Golgasht St, Tabriz, Iran
City
Tabriz
Postal code
5165665931
Approval date
2014-02-12, 1392/11/23
Ethics committee reference number
92199
Health conditions studied
1
Description of health condition studied
Congenital Nasolacrimal Duct Obstruction
ICD-10 code
Q10.5
ICD-10 code description
congenital stenosis and stricture of lacrimal duct
Primary outcomes
1
Description
epiphora or purulent discharge
Timepoint
1 week,1 month, 3 month, 6 month after surgery
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Side effects such as complications like panctum changes and corneal complications include abration and early exit stent in all children
Timepoint
1 week, 1 month, 3 month, and 6 month after surgery
Method of measurement
Questionnaire
Intervention groups
1
Description
All children will undergo probing of lacrimal duct, under general anesthesia, by an oculoplastic fellowship surgeon through upper canalicule with probe(00).Then lacrimal duct irrigation will be performed with normal saline-flourescein solution.The solution will be removed through nose with a special catheter.The irrigation will be considered difficult in the case of fluid reflux from canaliculi in adittion to fluid passage through nose.In these occasions monocanalicular intubation with monaca krawford will be attemped through upper canalicule.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikookari Educational and Treatment Center
Full name of responsible person
Dr Dima Andalib
Street address
Nikookari Educational and Treatment Center,Abbasi St, Tabriz, Iran
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology of Tabriz University of Medical Sciences
Full name of responsible person
Dr Seyyed Kazem Shakuri
Street address
Vice-chancellor for Research and Technology, central department No 2, Tabriz University of Medical Sciences, Golgasht St, Tabriz, Iran
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research and Technology of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Dima Andalib
Position
Associate professor of Ofhthalmology-Strabismus Fellowship(Oculoplasty)
Other areas of specialty/work
Street address
Vice-chancellor for Research and Technology, central department No 2, Tabriz University of Medical Sciences, Golgasht St, Tabriz, Iran
City
Tabriz
Postal code
5165665931
Phone
+98 41 1335 7310
Fax
+98 41 1657 7336
Email
dima1366@yahoo.com
Web page address
www.tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Dima Andalib
Position
Associate professor
Other areas of specialty/work
Street address
Vice-chancellor for Research and Technology, central department No 2, Tabriz University of Medical Sciences, Golgasht St, Tabriz, Iran
City
Tabriz
Postal code
5154645395
Phone
+98 41 1335 7310
Fax
+98 41 1657 7336
Email
dima1366@yahoo.com
Web page address
www.tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Shiva Farajpur
Position
Ophthalmology resident
Other areas of specialty/work
Street address
Vice-chancellor for Research and Technology, central department No 2, Tabriz University of Medical Sciences, Golgasht St, Tabriz, Iran
City
Tabriz
Postal code
5165665931
Phone
+98 41 1335 7310
Fax
Email
dr.farajpur@gmail .com
Web page address
www.tbzmed.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)