The Safety and Efficacy of Lacrimal Silicone Intubation for the Management of Epiphora

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01010659
Recruitment Status : Completed
First Posted : November 10, 2009
Last Update Posted : July 15, 2011
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Brief Summary:
The purpose of study is to investigate the safety and efficacy of lacrimal silicone intubation for the management of epiphora.

Condition or disease Intervention/treatment Phase
Epiphora Device: Lacrimal Tube Phase 4

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
Experimental: Lacrimal Tube
Dacryocystorhinostomy with silicone lacrimal intubation
Device: Lacrimal Tube
Lacrimal Tube
Other Name: Auro-lac

Primary Outcome Measures :
  1. Resolution of epiphora [ Time Frame: 15th Day, 1st Month, 6th Month and 12th month ]

Secondary Outcome Measures :
  1. Post operative complications [ Time Frame: 15th Day, 1st Month, 6th Month and 12th Month ]

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01010659

Aravind Eye Hospital
Madurai, Tamil Nadu, India, 625 020
Sponsors and Collaborators
Principal Investigator: Dr. Usha Kim, MBBS, DO Aravind Eye Hospital

Responsible Party: Dr. Usha Kim, Aravind Eye Hospital Identifier: NCT01010659     History of Changes
Other Study ID Numbers: 1PN1010940
First Posted: November 10, 2009    Key Record Dates
Last Update Posted: July 15, 2011
Last Verified: July 2011

Keywords provided by Aurolab:

Additional relevant MeSH terms:
Lacrimal Apparatus Diseases
Eye Diseases