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Level of Lacrimal Passage Obstruction

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ClinicalTrials.gov Identifier: NCT04240431
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Farag Khalil Ibrahiem, Minia University

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

Condition or disease Intervention/treatment
Lacrimal Apparatus Diseases Diagnostic Test: Probing /irrigation of lacrimal passages

Detailed Description:

In a 3 years period adult patients with obstructive epiphora were evaluated clinically by Probing /irrigation of lacrimal passages to detect anatomical level of obstruction.

The main site of obstruction was the common canaliculus where 2/3 of patients had canalicular problems. The second common site of obstruction is nasolacrimal duct followed by the puncti.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 223 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Days
Official Title: Symptomatic Acquired Lacrimal Passage Obstruction: Clinical Evaluation of the Level of Obstruction in Adult Patients of Upper Egypt
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : December 21, 2019
Actual Study Completion Date : December 21, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears

Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. Level of obstruction of lacrimal system [ Time Frame: 3 years ]
    The level was detected either Punctal, Canalicular, Nasolacrimal duct or Mixed



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • No previous lacrimal surgery
  • Congenital lacrimal obstructions

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04240431


Locations
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Egypt
Faculty of Medicine
Minya, Minia, Egypt, 61111
Sponsors and Collaborators
Minia University
Investigators
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Principal Investigator: Mohamed F Ibrahiem, MD Minia University
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Responsible Party: Mohamed Farag Khalil Ibrahiem, Assistant Professor, Minia University
ClinicalTrials.gov Identifier: NCT04240431    
Other Study ID Numbers: Minia2019
First Posted: January 27, 2020    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lacrimal Apparatus Diseases
Eye Diseases