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Clinical Trials/NCT04898933
NCT04898933CompletedNot Applicable

Lacrimal Deroofing for the Management of Epiphora From Lacrimal Punctal-Canalicular Abnormalities

Benha University1 site in 1 country39 target enrollmentStarted: January 20, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
39
Locations
1
Primary Endpoint
Munk scale for epiphora grading (0-5)

Study Overview

Brief Summary

Puncto-canalicular abnormalities, such as obstruction and canaliculitis, are a significant cause of epiphora. They involve proximal lacrimal drainage system. Proximal lacrimal obstructions classified into punctal stenosis canalicular obstructions. The basic principles in the treatment of punctal stenosis include creating an adequate opening, while maintaining the position of the punctum against the lacrimal lake, and preserving the lacrimal pump function. The severity of epiphora can be valued trough a grading system such as the Munk scale, fluorescein dye disappearance test, and syringing and probing and contrast dacryocystography.

Canaliculitis is defined as infection of the proximal part of the lacrimal drainage system. This condition can be caused by primary infectious organisms or secondary to punctal plugs and lacrimal stents. Diagnosing canaliculitis is frequently misdiagnosed. The management includes conservative measures, local massage, syringing, and irrigation. Nevertheless, refractory cases required surgical intervention.

Detailed Description

Purpose: To report outcomes of proximal lacrimal deroofing in the management of proximal lacrimal drainage system abnormalities.

Inclusion criteria: At least 18 years old patients with lacrimal punctum stenosis and/or canaliculitis.

Exclusion Criteria: Trauma, Thyroid eye disease, lacrimation and other causes of epiphora.

Evaluation: All patients underwent a comprehensive ophthalmic examination, and lacrimal drainage evaluation at baseline,2 weeks and 6 months after the surgery.

Outcome Measures:

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • epiphora due to lacrimal punctum stenosis and/or canaliculitis.

Exclusion Criteria

  • Trauma, Thyroid eye disease, lacrimation and other causes of epiphora.

Outcomes

Primary Outcomes

Munk scale for epiphora grading (0-5)

Time Frame: 6 months

0 No epiphora ,1 Epiphora requiring dabbing less than twice a day, 2 Epiphora requiring dabbing 2-4 times a day, 3 Epiphora requiring dabbing 5-10 times a day, 4 Epiphora requiring dabbing more than 10 times a day, 5 Constant epiphora.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Tarek Roshdy mohamed Mahgoub ELhamaky

Associate professor

Benha University

Study Sites (1)

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