The Safety and Efficacy of Lacrimal Silicone Intubation for the Management of Epiphora
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|ClinicalTrials.gov Identifier: NCT01010659|
Recruitment Status : Completed
First Posted : November 10, 2009
Last Update Posted : July 15, 2011
|Condition or disease||Intervention/treatment||Phase|
|Epiphora||Device: Lacrimal Tube||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prospective Clinical Evaluation of Dacryocystorhinostomy (DCR) With Lacrimal Intubation|
|Study Start Date :||November 2009|
|Primary Completion Date :||March 2011|
|Study Completion Date :||June 2011|
Experimental: Lacrimal Tube
Dacryocystorhinostomy with silicone lacrimal intubation
Device: Lacrimal Tube
Other Name: Auro-lac
- Resolution of epiphora [ Time Frame: 15th Day, 1st Month, 6th Month and 12th month ]
- Post operative complications [ Time Frame: 15th Day, 1st Month, 6th Month and 12th Month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01010659
|Aravind Eye Hospital|
|Madurai, Tamil Nadu, India, 625 020|
|Principal Investigator:||Dr. Usha Kim, MBBS, DO||Aravind Eye Hospital|