3 Snip Punctoplasty With and Without Mitomycine C.

October 15, 2022 updated by: Ehab Tharwat, Al-Azhar University

Comparative Study on 3 Snip Punctoplasty With and Without Mitomycine C in the Management of Punctual Stenosis or Occlusion

Punctal stenosis is a progressive constriction of the puncta with resultant epiphora. One of the most effective treatment options is 1- to 4-snip punctoplasty combined with or without Mitomycin-C.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

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

  • Egypt
    • New Damietta
      • Damieta, New Damietta, Egypt, 34517
        • Ehab tharwat

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

16 years to 63 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with recurrence of punctal stenosis at the end of 1 month following punctal dilatation.

Exclusion Criteria:

  • patients with associated lacrimal passage obstruction

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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 3-snip punctoplasty
Procedure: 3-snip punctoplasty
punctoplasty, more commonly known as watery eye surgery, is an ophthalmic surgical procedure performed to correct punctal stenosis (a condition that causes tears to overflow from the eyes) by widening the punctal opening to allow the tears to drain with ease.
Active Comparator: 3-snip punctoplasty with mitomycin C
Procedure: 3-snip punctoplasty and Mitomycin C

punctoplasty, more commonly known as watery eye surgery, is an ophthalmic surgical procedure performed to correct punctal stenosis (a condition that causes tears to overflow from the eyes) by widening the punctal opening to allow the tears to drain with ease.

Mitomycin C is a chemotherapeutic agent that acts by inhibiting DNA synthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Punctal patency
Time Frame: Baseline
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
Baseline
Punctal patency
Time Frame: 1 week postoperative
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
1 week postoperative
Punctal patency
Time Frame: 1 month postoperative
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
1 month postoperative
Punctal patency
Time Frame: 3 months postoperative
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
3 months postoperative
Presence of Epiphora
Time Frame: Baseline
It will be assessed by inspection of the lid by slitlamb examination.
Baseline
Presence of Epiphora
Time Frame: 1 week postoperative
It will be assessed by inspection of the lid by slitlamb examination.
1 week postoperative
Presence of Epiphora
Time Frame: 1 month postoperative
It will be assessed by inspection of the lid by slitlamb examination.
1 month postoperative
Presence of Epiphora
Time Frame: 3 month postoperative
It will be assessed by inspection of the lid by slitlamb examination.
3 month postoperative

Collaborators and Investigators

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

Sponsor

Al-Azhar 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)

June 1, 2021

Primary Completion (Actual)

June 1, 2022

Study Completion (Actual)

June 10, 2022

Study Registration Dates

First Submitted

October 15, 2022

First Submitted That Met QC Criteria

October 15, 2022

First Posted (Actual)

October 19, 2022

Study Record Updates

Last Update Posted (Actual)

October 19, 2022

Last Update Submitted That Met QC Criteria

October 15, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3 Snip Punctoplasty

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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