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

Prospective Clinical Evaluation of Dacryocystorhinostomy (DCR) With Lacrimal Intubation

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01010659

Enrollment

Registered

2009-11-10

Start date

2009-11-30

Completion date

2011-06-30

Last updated

2011-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epiphora

Keywords

Dacryocystorhinostomy

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.

Interventions

DEVICELacrimal Tube

Lacrimal Tube

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

15 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026