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

Prospective Clinical Evaluation of Dacryocystorhinostomy (DCR) With Lacrimal Intubation

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

Study Overview

• Status: Completed
• Conditions: Epiphora
• Intervention / Treatment: Device: Lacrimal Tube

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
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Tamil Nadu
    • Madurai, Tamil Nadu, India, 625 020
      • Aravind Eye Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lacrimal Tube; Dacryocystorhinostomy with silicone lacrimal intubation	Device: Lacrimal Tube; Lacrimal Tube; Other Names: Auro-lac

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Resolution of epiphora	15th Day, 1st Month, 6th Month and 12th month

Secondary Outcome Measures

Outcome Measure	Time Frame
Post operative complications	15th Day, 1st Month, 6th Month and 12th Month

Collaborators and Investigators

• Sponsor: Aurolab
• Investigators: Principal Investigator: Dr. Usha Kim, MBBS, DO, Aravind Eye Hospital

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: November 5, 2009
• First Submitted That Met QC Criteria: November 9, 2009
• First Posted (Estimate): November 10, 2009

Study Record Updates

• Last Update Posted (Estimate): July 15, 2011
• Last Update Submitted That Met QC Criteria: July 14, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: Dacryocystorhinostomy
• Additional Relevant MeSH Terms: Eye Diseases; Lacrimal Apparatus Diseases
• Other Study ID Numbers: 1PN1010940