NCT04240431

Brief Summary

Detect anatomical level of acquired lacrimal passage obstructions among patients with epiphora. They were evaluated and divided into four groups Punctal, Canalicular, Nasolacrimal duct and Mixed groups according to level of obstruction

Trial Health

87
On Track

Trial Health Score

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

Enrollment
223

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Typical duration for all trials

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

January 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 21, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 27, 2020

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

3 years

First QC Date

January 21, 2020

Last Update Submit

January 21, 2020

Conditions

Lacrimal Apparatus Diseases

Outcome Measures

Primary Outcomes (1)

  • Level of obstruction of lacrimal system

    The level was detected either Punctal, Canalicular, Nasolacrimal duct or Mixed

    3 years

Study Arms (1)

Epiphora

Adult patients suffering from watering of the eye included in the study to detect level of obstruction

Diagnostic Test: Probing /irrigation of lacrimal passages

Interventions

Probing /irrigation of lacrimal passagesDIAGNOSTIC_TEST

Probing of the lacrimal passage was done using #00 Bowman's lacrimal probe which can reveal any narrowing (resistance) or obstruction (soft stop) of the canaliculi during its advancement from punctum towards the lacrimal sac.

Epiphora

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients were divided into four main groups according to site of narrowing or obstruction Punctal group, Canalicular group, NLD group and Mixed group who had 2 or more levels of narrowing or obstruction

You may qualify if:

  • Watering of the eye
  • Acquired lacrimal obstructions
  • Adult patients with

You may not qualify if:

  • No previous lacrimal surgery
  • Congenital lacrimal obstructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Minya, Minya Governorate, 61111, Egypt

Location

MeSH Terms

Conditions

Lacrimal Apparatus Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Mohamed F Ibrahiem, MD

    Minia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 21, 2020

First Posted

January 27, 2020

Study Start

January 1, 2017

Primary Completion

December 21, 2019

Study Completion

December 21, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)