Level of Lacrimal Passage Obstruction

• Sponsor: Minia University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04240431
• Collaborator: (none)
• Enrollment: 223
• Location: 1
• Actual Duration (Months): 35.6
• Patients Per Site Per Month: 6.3

Study Details

Study Description

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	Phase
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.

Study Design

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

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. Level of obstruction of lacrimal system [3 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Watering of the eye

• Acquired lacrimal obstructions

• Adult patients with

Exclusion Criteria:

• No previous lacrimal surgery

• Congenital lacrimal obstructions

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine	Minya	Minia	Egypt	61111

Sponsors and Collaborators

• Minia University

Investigators

• Principal Investigator: Mohamed F Ibrahiem, MD, Minia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed Farag Khalil Ibrahiem, Assistant Professor, Minia University
• ClinicalTrials.gov Identifier: NCT04240431
• Other Study ID Numbers: Minia2019
• First Posted: Jan 27, 2020
• Last Update Posted: Jan 27, 2020
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Lacrimal Apparatus Diseases

Study Results

No Results Posted as of Jan 27, 2020