The purpose of this study is compare the sucsses rate of monocanalicular versus bicanalicular intubation of nasolacrimal duct for nasolacrimal duct stenosis in adult. The patients with nasolacrimal duct stenosis and water entranse into troat + water reflux from other panctum in irrigation test are included in this study. The patients with privious lacrimal surgery, privious lacrimal trauma, sinus disease, punctal or lid disease, ocular surface disease, removal of silicon stent before 3 months, follow up <3 months are excluded. In a prospective randomized clinical trial, 56 eyes with nasolacrimal duct stenosis undergo either monocanalicular silicone intubation (35 eyes) or bicanalicular silicone intubation ( 35 eyes).Tube removal was planned for 3 months postoperatively. Treatment success was defined abcence of epiphora at 3 months after tube removal.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201102234580N1
Registration date:2011-04-13, 1390/01/24
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-04-13, 1390/01/24
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
Tabriz university of medical sciences
Expected recruitment start date
2010-10-29, 1389/08/07
Expected recruitment end date
2012-03-10, 1390/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Monocanalicular versus Bicanalicular Silicon Tube Intubation for Nasolacrimal
Duct Stenosis in Adults
Public title
Monocanalicular versus Bicanalicular Silicon Tube Intubation for Nasolacrimal
Duct Stenosis in Adults
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1.epiphora 2.water entranse into troat + water reflux from other panctum in irrigation test 3.DDT test> 5 minutes 3.NLD obstruction in scinthigraphy. Exclusion criteria: 1.privious lacrimal surgery 2.privious lacrimal trauma 3.sinus disease
4.punctal or lid disease 5.ocular surface disease
6.removal of silicon stent before 3 months 7.follow up <3 months.
Age
From 14 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Randomization (investigator's opinion)
Randomized
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
Ethics committee of Tabriz university of medical sciences
Street address
Tabriz university of medical sciences
City
Tabriz
Postal code
Approval date
2010-09-27, 1389/07/05
Ethics committee reference number
5/4/4867
Health conditions studied
1
Description of health condition studied
Nasolacrimal duct stenosis
ICD-10 code
H04.5
ICD-10 code description
Stenosis and insufficiency of lacrimal passages
Primary outcomes
1
Description
Abcense of epiphora
Timepoint
3 months after tube removal
Method of measurement
DDT test
Secondary outcomes
1
Description
complication
Timepoint
3 months after tube removal
Method of measurement
examination
Intervention groups
1
Description
group 1: monoanalicular silicon intubation
Category
Treatment - Surgery
2
Description
Group2: bicanalicular silicon tube intubation
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikookary Eye Hospital
Full name of responsible person
Dr. Dima Andalib
Street address
Abbasi st.
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz university of medical sciences
Full name of responsible person
Vice chancellory for research
Street address
Tabriz university of medical sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
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
Nikookary hospital
Full name of responsible person
Dr. Dima Andalib
Position
Assistant professor
Other areas of specialty/work
Street address
Abbasi st.
City
Tabriz
Postal code
Phone
+98 41 1655 1332
Fax
Email
andalibd@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nikookary hospital
Full name of responsible person
Dr. Dima Andalib
Position
Assistant professor
Other areas of specialty/work
Street address
Abbasi st.
City
Tabriz
Postal code
Phone
+98 41 1655 1332
Fax
Email
andalibd@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)