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

Epiphora Clinical Trial

Official title:

Prospective Clinical Evaluation of Dacryocystorhinostomy (DCR) With Lacrimal Intubation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01010659
• Other study ID #: 1PN1010940
• Status: Completed
• Phase: Phase 4
• First received: November 5, 2009
• Last updated: July 14, 2011
• Start date: November 2009
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: Aurolab
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epiphora

Intervention

Device:
• Lacrimal Tube
Lacrimal Tube

Locations

Country	Name	City	State
India	Aravind Eye Hospital	Madurai	Tamil Nadu

Sponsors (1)

Lead Sponsor	Collaborator
Aurolab

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of epiphora		15th Day, 1st Month, 6th Month and 12th month	No
Secondary	Post operative complications		15th Day, 1st Month, 6th Month and 12th Month	Yes