NCT04898933

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
8 months until next milestone

Study Start

First participant enrolled

January 20, 2022

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 23, 2025

Completed
Last Updated

May 22, 2025

Status Verified

May 1, 2025

Enrollment Period

2.9 years

First QC Date

May 19, 2021

Last Update Submit

May 18, 2025

Conditions

Keywords

lacrimalepiphora

Outcome Measures

Primary Outcomes (1)

  • Munk scale for epiphora grading (0-5)

    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.

    6 months

Interventions

After infiltration anesthesia, patient underwent proximal lacrimal deroofing. Proper punctal dilatation is done, followed by combined 1 snip punctoplasty with a lateral canaliculotomy/ Punctotomy and posterior canaliculotomy of the lateral third. En-bloc expulsion of the concretion was done in case of canaliculitis.

Eligibility Criteria

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

at least 18 years old patients

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

INMC

Abu Dhabi, 46266, United Arab Emirates

Location

MeSH Terms

Conditions

Eyelid DiseasesLacrimal Apparatus Diseases

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

  • Tarek Elhamaky

    Benha University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 24, 2021

Study Start

January 20, 2022

Primary Completion

December 13, 2024

Study Completion

January 23, 2025

Last Updated

May 22, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

by direct contact through email

Shared Documents
STUDY PROTOCOL
Time Frame
unlimited

Locations