This is a Clinical trial interventional study on patients with persistent congenital Nasolacrimal duct obstruct in order to evaluate the results of probing without irrigation in special clinics for 3yr in Kerman , Iran .
Nasolacrimal duct obstruction is defined by persistent epiphora with or without mucopurulent discharge from birthday. The inclusion criteria are epiphora , increased tear meniscus , mucopurulent discharge and the children who have been under probing are excluding.
In intervention group the probing is performing without irrigation under short time general anesthesia without Intra Venuse line,In control group the probing is performing with irrigation under general anesthesia with Intra Venuse Line .However Probing success is defined as a complete remission of epiphora and mucopurulent discharge at 3 mounths.
General information
Acronym
NLDO
IRCT registration information
IRCT registration number:IRCT201108227219N3
Registration date:2011-12-24, 1390/10/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-12-24, 1390/10/03
Registrant information
Name
Esmat Karbassi
Name of organization / entity
Kerman Medicine University
Country
Iran (Islamic Republic of)
Phone
+98 34 1211 1132
Email address
mkarbasi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman Medical University of Science
Expected recruitment start date
2009-08-01, 1388/05/10
Expected recruitment end date
2012-05-21, 1391/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of efficacy of nasolacrimal duct obstruction by probing without irrigation in chideren under 3 years old
Public title
The effect of probing without irrigation
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria :The main eligibility criteria were epiphora, increased tear meniscus, mucopurulent discharge. The fluorscein dye disappearance test was used to confirm the diagnosis.
exclusion criteria : the patients who have history of failed probing .
Age
From 1 year old to 3 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
200
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
Kerman University of Medical Sciences
Street address
Jomhori Eslami BL , Kerman , Iran
City
Kerman
Postal code
Approval date
2009-01-27, 1387/11/08
Ethics committee reference number
10/11
Health conditions studied
1
Description of health condition studied
Nasolacrimal Duct Obstruction
ICD-10 code
H04.2
ICD-10 code description
Epiphora
Primary outcomes
1
Description
Epiphora
Timepoint
Before operation ,one and three Months after operation
Method of measurement
Tear meniscus measurment
Secondary outcomes
1
Description
Chronic Dacryocytitis
Timepoint
Befor Operation, One and Three months after operation
Method of measurement
mucopurulent Discharge`s Signe
Intervention groups
1
Description
Intervention Group : probing without irrigation , without Intra Venuse Line under short general unesthesia .
Category
Treatment - Surgery
2
Description
Control Group : Probing with irrigation under General Unesthesia with Intra Venuse Line.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ophthalmic Clinics Affiliated With The University of Kerman, Kerman
Full name of responsible person
Esmat Karbassi
Street address
Jomhori Eslami BL , Kerman , Iran
City
Kerman
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences, Department of Research
Full name of responsible person
Esmat Karbassi
Street address
Jomhori Eslami BL , Kerman ,Iran
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman University of Medical Sciences, Department of Research
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
Kerman University of Medical Sciences
Full name of responsible person
ُSaleh Hamzeh
Position
Medical Student
Other areas of specialty/work
Street address
Jomhori Eslami BL , Kerman , Iran
City
Kerman
Postal code
Phone
+98 936 642 8868
Fax
Email
Sh_karbassi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Esmat Karbassi
Position
Strabismus Subspecialty Fellowship
Other areas of specialty/work
Street address
Jomhori Eslami BL , Kerman , Iran
City
Kerman
Postal code
Phone
+98 913 340 0196
Fax
Email
Sh_karbassi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Saleh Hamzeh
Position
Medical Student
Other areas of specialty/work
Street address
Jomhori Eslami BL , Kerman , Iran
City
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)