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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-06-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Epiphora

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lacrimal Tube

Dacryocystorhinostomy with silicone lacrimal intubation

Group Type EXPERIMENTAL

Lacrimal Tube

Intervention Type DEVICE

Lacrimal Tube

Interventions

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Lacrimal Tube

Intervention Type DEVICE

Other Intervention Names

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Auro-lac

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No