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Completed

NCT Number: NCT01010659

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

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

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Key information

Age range

15 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Aravind Eye Hospital

Madurai, Tamil Nadu, 625 020, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lacrimal Tube

Device

Lacrimal Tube

Other names: Auro-lac

Primary outcomes

  1. Resolution of epiphora

    Time frame: 15th Day, 1st Month, 6th Month and 12th month

Secondary outcomes

  1. Post operative complications

    Time frame: 15th Day, 1st Month, 6th Month and 12th Month

Sponsors and collaborators

Lead sponsor

Aurolab

Other

Registry information

Official study title

Prospective Clinical Evaluation of Dacryocystorhinostomy (DCR) With Lacrimal Intubation

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 10, 2009
Registry last updated
Jul 15, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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