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Note: This record shows only 21 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: CTRI
Last refreshed on: 14 January 2019
Main ID:  CTRI/2009/091/000923
Date of registration: 23-11-2009
Prospective Registration: Yes
Primary sponsor: Aurolab
Public title: The safety and efficacy of silicone tube for the management of watering eye
Scientific title: Prospective clinical evaluation of Dacryocystorhinostomy (DCR) with lacrimal intubation
Date of first enrolment: 30-11-2009
Target sample size: 0
Recruitment status: Open to Recruitment
URL:  http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=1076
Study type:  Interventional
Study design:  Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label
 
Phase:  Phase 4
Countries of recruitment
India
Contacts
Name: Dr. Usha Kim   
Address:  Aravind Eye Hospital Anna Nagar 625 020 Madurai, TAMIL NADU India
Telephone: 91-452 4356100
Email: orbit@aravind.org
Affiliation:  Aravind Eye Hospital
Name: Mr. A. Heber David   
Address:  Aravind Eye Hospital Anna Nagar 625 020 Madurai, TAMIL NADU India
Telephone: 91-452 4356100
Email: orbit@aravind.org
Affiliation:  Aravind Eye Hospital
Key inclusion & exclusion criteria
Inclusion criteria: Subjects having epiphora
Canalicular blockade ascertained with probing
Chronic dacryocystitis
Mucocele

Exclusion criteria: Absent puncta
Acute on chronic dacryocrystitis
Noticeable lid laxity
Previous lacrimal surgery
Patients younger than 15 years
Suspicion of malignancy
Post traumatic lids


Age minimum:
Age maximum:
Gender:
Health Condition(s) or Problem(s) studied
Epiphora
Intervention(s)
Intervention1: Lacrimal silicone intubation: Device
Control Intervention1: NIL: NIL
Primary Outcome(s)
Resolution of epiphora------Timepoint: 15th day, 1st month, 6th month, and 12th month.
Secondary Outcome(s)
Post operative complications------Timepoint: 15th day, 1st month, 6th month and 12th month
Secondary ID(s)
NCT01010659
Source(s) of Monetary Support
Aurolab, Madurai, India
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
URL:
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