NCT01010659

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Nov 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 10, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

July 15, 2011

Status Verified

July 1, 2011

Enrollment Period

1.3 years

First QC Date

November 5, 2009

Last Update Submit

July 14, 2011

Conditions

Epiphora

Keywords

Dacryocystorhinostomy

Outcome Measures

Primary Outcomes (1)

  • Resolution of epiphora

    15th Day, 1st Month, 6th Month and 12th month

Secondary Outcomes (1)

  • Post operative complications

    15th Day, 1st Month, 6th Month and 12th Month

Study Arms (1)

Lacrimal Tube

EXPERIMENTAL

Dacryocystorhinostomy with silicone lacrimal intubation

Device: Lacrimal Tube

Interventions

Lacrimal TubeDEVICE

Lacrimal Tube

Also known as: Auro-lac
Lacrimal Tube

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Subjects having epiphora
  • Canalicular blockade ascertained with probing
  • Chronic dacryocystitis
  • Mucocele

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aravind Eye Hospital

Madurai, Tamil Nadu, 625 020, India

Location

MeSH Terms

Conditions

Lacrimal Apparatus Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Dr. Usha Kim, MBBS, DO

    Aravind Eye Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 5, 2009

First Posted

November 10, 2009

Study Start

November 1, 2009

Primary Completion

March 1, 2011

Study Completion

June 1, 2011

Last Updated

July 15, 2011

Record last verified: 2011-07

Locations

IN(1)