The Safety and Efficacy of Lacrimal Silicone Intubation for the Management of Epiphora
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Prospective Clinical Evaluation of Dacryocystorhinostomy (DCR) With Lacrimal Intubation|
- Resolution of epiphora [ Time Frame: 15th Day, 1st Month, 6th Month and 12th month ] [ Designated as safety issue: No ]
- Post operative complications [ Time Frame: 15th Day, 1st Month, 6th Month and 12th Month ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2009|
|Study Completion Date:||June 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
Experimental: Lacrimal Tube
Dacryocystorhinostomy with silicone lacrimal intubation
Device: Lacrimal Tube
Other Name: Auro-lac
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01010659
|Aravind Eye Hospital|
|Madurai, Tamil Nadu, India, 625 020|
|Principal Investigator:||Dr. Usha Kim, MBBS, DO||Aravind Eye Hospital|