Outcome of external dacryocystorhinostomy with monocanalicular intubation versus bicanalicular intubation in patient with primary acquired nasolacrimal duct obstruction
Patients complaining of lacrimation and other signs and symptoms of nasolacrimal duct obstruction, referred to Nikookari hospital (Tabriz, Iran), will undergo clinical examination, probing and irrigation of nasolacrimal duct. Patients with a history of surgery on nasolacrimal ducts or with a diagnosis of secondary obstruction of nasolacrimal ducts will be excluded from the study. Fifty-one patients will be chosen and randomly divided in two groups of A and B. In group A intervention includes external dacteriucyctrinostomy with intubation monocanalicular (silicon tube) and in group B intervention includes external dacteriucyctrinostomy with bicanalicolar intubation . After six weeks silicon tube will be removed and patients will be followed for three month. The success rate of interventions will be evaluated by MUNK scoring system.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201409166033N4
Registration date:2014-09-26, 1393/07/04
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-09-26, 1393/07/04
Registrant information
Name
Reza Nabie
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 411365577236
Email address
nabier@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2012-07-10, 1391/04/20
Expected recruitment end date
2012-09-10, 1391/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Outcome of external dacryocystorhinostomy with monocanalicular intubation versus bicanalicular intubation in patient with primary acquired nasolacrimal duct obstruction
Public title
Treatment of Nasolacrimal duct obstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patient with primary acquire nasolacrimal duct obstruction Exclusion criteria: History of surgery on nasolacrimal duct, Secondary obstruction in nasolacrimal duct
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
51
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University Of Medical Sciences
Street address
Room 202 , second floor , Research deputy , Tabriz University Of Medical Sciences , Daneshgah street
City
Tabriz
Postal code
Approval date
2012-11-12, 1391/08/22
Ethics committee reference number
9391
Health conditions studied
1
Description of health condition studied
primary acquire nasolacrimal duct obstruction
ICD-10 code
H04.3
ICD-10 code description
Acute and unspecified inflammation of lacrimal passages
Primary outcomes
1
Description
The degree of nasolacrimal duct obstruction
Timepoint
Every 6 weeks
Method of measurement
MUNK scoring system
Secondary outcomes
1
Description
Foreign body sensation
Timepoint
Every 6 weeks
Method of measurement
MUNK scoring system
Intervention groups
1
Description
External dacteriucyctrinostomy with monocanalicular intubation
Category
Treatment - Surgery
2
Description
External dacteriucyctrinostomy with bicanalicular intubation
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikookari Hospital
Full name of responsible person
Rambod Saburihamed
Street address
Room 303, 3rd floor , NIkookari Hospital , Abbasi street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of Tabriz University Of Medical Sciences
Full name of responsible person
Mohamadreza Rashidi
Street address
Room 201 , second floor , Research deputy , Tabriz University Of Medical Sciences , Daneshgah street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy 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
Raheleh Entezari
Position
physician
Other areas of specialty/work
Street address
Room 201, Second floor , NIkookari Hospital , Abbasi street
City
Tabriz
Postal code
Phone
+98 41 3554 3423
Fax
Email
raheleh.entezari@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Reza Nabei
Position
Ophatalmologist
Other areas of specialty/work
Street address
Room 300, 3rd floor , NIkookari Hospital , Abbasi street
City
Tabriz
Postal code
Phone
+98 41 3334 4546
Fax
Email
r_nabie@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Amir Kamalifar
Position
physician
Other areas of specialty/work
Street address
Room 202 , second floor , Research deputy , Tabriz University Of Medical Sciences , Daneshgah street
City
Tabriz
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)