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

This study has been completed.
Sponsor:
Information provided by:
Aurolab
ClinicalTrials.gov Identifier:
NCT01010659
First received: November 5, 2009
Last updated: July 14, 2011
Last verified: July 2011
  Purpose

The purpose of study is to investigate the safety and efficacy of lacrimal silicone intubation for the management of epiphora.


Condition Intervention Phase
Epiphora
Device: Lacrimal Tube
Phase 4

Study Type: Interventional
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

Further study details as provided by Aurolab:

Primary Outcome Measures:
  • Resolution of epiphora [ Time Frame: 15th Day, 1st Month, 6th Month and 12th month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Post operative complications [ Time Frame: 15th Day, 1st Month, 6th Month and 12th Month ] [ Designated as safety issue: Yes ]

Enrollment: 30
Study Start Date: November 2009
Study Completion Date: June 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Lacrimal Tube
Dacryocystorhinostomy with silicone lacrimal intubation
Device: Lacrimal Tube
Lacrimal Tube
Other Name: Auro-lac

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.

  Eligibility

Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01010659

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

No publications provided

Responsible Party: Dr. Usha Kim, Aravind Eye Hospital
ClinicalTrials.gov Identifier: NCT01010659     History of Changes
Other Study ID Numbers: 1PN1010940
Study First Received: November 5, 2009
Last Updated: July 14, 2011
Health Authority: India: Ministry of Health

Keywords provided by Aurolab:
Dacryocystorhinostomy

ClinicalTrials.gov processed this record on November 25, 2014