Clinical Trial: The Safety and Efficacy of Lacrimal Silicone Intubation for the Management of Epiphora
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Prospective Clinical Evaluation of Dacryocystorhinostomy (DCR) With Lacrimal Intubation
Brief Summary: The purpose of study is to investigate the safety and efficacy of lacrimal silicone intubation for the management of epiphora.
Detailed Summary:
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.
Sponsor: Aurolab
Current Primary Outcome: Resolution of epiphora [ Time Frame: 15th Day, 1st Month, 6th Month and 12th month ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Post operative complications [ Time Frame: 15th Day, 1st Month, 6th Month and 12th Month ]
Original Secondary Outcome: Same as current
Information By: Aurolab
Dates:
Date Received: November 5, 2009
Date Started: November 2009
Date Completion:
Last Updated: July 14, 2011
Last Verified: July 2011
