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

Study Overview
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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.

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.

Official Title
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Prospective Clinical Evaluation of Dacryocystorhinostomy (DCR) With Lacrimal Intubation

Conditions
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Epiphora

Intervention / Treatment
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* Device: Lacrimal Tube


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lacrimal Tube<br>Dacryocystorhinostomy with silicone lacrimal intubation | Device: Lacrimal Tube<br>* Lacrimal Tube<br>* Other names: Auro-lac;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dacryocystorhinostomy