The Safety and Efficacy of Lacrimal Silicone Intubation for the Management of Epiphora
Primary Purpose
Epiphora
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Lacrimal Tube
Sponsored by
About this trial
This is an interventional treatment trial for Epiphora focused on measuring Dacryocystorhinostomy
Eligibility Criteria
Inclusion Criteria:
- Subjects having epiphora
- Canalicular blockade ascertained with probing
- Chronic dacryocystitis
- Mucocele
Exclusion Criteria:
- Absent puncta
- Acute on chronic dacryocystitis
- Noticeable lid laxity
- Previous lacrimal surgery
- Patients younger than 15 years
- Suspicion of malignancy
- Post traumatic lids
- Bony deformity
Sites / Locations
- Aravind Eye Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lacrimal Tube
Arm Description
Dacryocystorhinostomy with silicone lacrimal intubation
Outcomes
Primary Outcome Measures
Resolution of epiphora
Secondary Outcome Measures
Post operative complications
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01010659
Brief Title
The Safety and Efficacy of Lacrimal Silicone Intubation for the Management of Epiphora
Official Title
Prospective Clinical Evaluation of Dacryocystorhinostomy (DCR) With Lacrimal Intubation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Aurolab
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of study is to investigate the safety and efficacy of lacrimal silicone intubation for the management of epiphora.
Detailed Description
Epiphora is an overflow of tears,usually caused by insufficient drainage of the tear film from the eye.The most common cause is a blockage of the lacrimal ducts located next to the nose, but the condition may also result from the excessive production of tears. Epiphora is a symptom rather than a disease and may be caused by a variety of conditions.
30 subjects will be recruited for this study, informed consent will be taken from the willing subjects. Complete ophthalmic evaluation would be performed including visual acuity. Diagnosis would be made on history of epiphora, regurgitation test, lids examination, nasal examination, probing and syringing. Standard procedure of Dacryocystorhinostomy (DCR) would be adopted in all cases with lacrimal intubation.
Syringing will be done on first follow up visit and skin sutures will also be removed. Tightness and mobility of the silicone tube will be checked. The tube is kept in place for 3-6 months according to need and then finally removed. The patency of lacrimal passage will be investigated by irrigation. A successful outcome will be defined as resolution of symptoms like epiphora and discharge and a patent lacrimal system on irrigation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epiphora
Keywords
Dacryocystorhinostomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lacrimal Tube
Arm Type
Experimental
Arm Description
Dacryocystorhinostomy with silicone lacrimal intubation
Intervention Type
Device
Intervention Name(s)
Lacrimal Tube
Other Intervention Name(s)
Auro-lac
Intervention Description
Lacrimal Tube
Primary Outcome Measure Information:
Title
Resolution of epiphora
Time Frame
15th Day, 1st Month, 6th Month and 12th month
Secondary Outcome Measure Information:
Title
Post operative complications
Time Frame
15th Day, 1st Month, 6th Month and 12th Month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects having epiphora
Canalicular blockade ascertained with probing
Chronic dacryocystitis
Mucocele
Exclusion Criteria:
Absent puncta
Acute on chronic dacryocystitis
Noticeable lid laxity
Previous lacrimal surgery
Patients younger than 15 years
Suspicion of malignancy
Post traumatic lids
Bony deformity
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Usha Kim, MBBS, DO
Organizational Affiliation
Aravind Eye Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aravind Eye Hospital
City
Madurai
State/Province
Tamil Nadu
ZIP/Postal Code
625 020
Country
India
12. IPD Sharing Statement
Learn more about this trial
The Safety and Efficacy of Lacrimal Silicone Intubation for the Management of Epiphora
We'll reach out to this number within 24 hrs