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

Phase 4

Completed

• Conditions: Epiphora
• Interventions: Device: Lacrimal Tube

• Registration Number: NCT01010659
• Lead Sponsor: Aurolab

Brief Summary

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

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 Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-05
• Study First Submitted QC: 2009-11-09
• Study First Posted: 2009-11-10
• Primary Completion: 2011-03
• Study Completion: 2011-06
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-14
• Last Update Posted: 2011-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Lacrimal Tube	Lacrimal Tube	Dacryocystorhinostomy with silicone lacrimal intubation

Primary Outcome Measures

Name	Time	Method
Resolution of epiphora	15th Day, 1st Month, 6th Month and 12th month

Secondary Outcome Measures

Name	Time	Method
Post operative complications	15th Day, 1st Month, 6th Month and 12th Month

Trial Locations

Locations (1)

Aravind Eye Hospital; 🇮🇳 Madurai, Tamil Nadu, India