Lacrimal Deroofing for Epiphora From Punctal Abnormalities

May 18, 2025 updated by: Tarek Roshdy mohamed Mahgoub ELhamaky, Benha University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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:

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.

Grading of External Lacrimal Puncum (0-5); score 0: No papilla and punctum (punctal atresia); surgery to create a papilla, score1: Papilla is covered by a membrane; a #25 needle, followed by a punctal finder. Exudative or true membrane or fibrosis, difficult to recognize with standard punctum dilator, score 2: Less than normal size, but recognizable; a punctal finder and, then a standard punctum dilator required, score 3: Normal; regular punctum dilator required, score 4: Small slit (< 2 mm); no intervention required, score 5 Large slit (≥ 2 mm); no intervention required.

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

at least 18 years old patients

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Benha University

Investigators

  • Principal Investigator: Tarek Elhamaky, Benha University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2022

Primary Completion (Actual)

December 13, 2024

Study Completion (Actual)

January 23, 2025

Study Registration Dates

First Submitted

May 19, 2021

First Submitted That Met QC Criteria

May 19, 2021

First Posted (Actual)

May 24, 2021

Study Record Updates

Last Update Posted (Actual)

May 22, 2025

Last Update Submitted That Met QC Criteria

May 18, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Hamaky12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

by direct contact through email

IPD Sharing Time Frame

unlimited

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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