Comparison Between Mini Monaka,Perforated Plugs and 3-Snip Punctoplasty in Punctal Stenosis

June 1, 2024 updated by: Almoatz bellah zohier Mohammed, Assiut University

Comparison Between Mini Monaka,Perforated Plugs and 3-Snip Punctoplasty in Punctal Stenosis.

To compare the result of mini monaka to perforated plug and 3 snip punctoplasty in management of punctal stenosis.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Punctal stenosis is a common disorder of the punctum. It is an important cause of epiphora and accounted for 8% of all patients presenting with epiphora and 3% of all lacrimal drainage disorders. Although numerous factors have been implicated as causative agents, the exact pathogenesis is still elusive. The widely believed hypothesis that histological studies have supported is a common mechanism involving inflammation leading to fibrosis and subsequent stenosis .A stenotic punctum can be easily diagnosed by slit-lamp examination, while probing and irrigation of the lacrimal pathway is usually required to exclude a more distal obstruction There are no uniformly acceptable guidelines for the management of punctal stenosis. Several modalities described include punctal dilatation, 1-snip punctoplasty, 2-snip punctoplasty, 3-snip punctoplasty, rectangular 3-snip punctoplasty, 4-snip punctoplasty, punctal punching with Kelly's or Rsess punch, punctoplasty with mitomycin C, balloon punctoplasty, balloon puncta-canaliculoplasty, and inserting perforated punctal plugs, self-retaining bicanaliculata stents, or Mini-Monaka . The mini-monaka is a silicone post canalicular stent designed to repair canalicular lacerations. It is designed to fit snugly into the punctum and ampulla without any suturing .A perforated punctal plug can be put into the opening of the tear canal to allow drainage of tears. These are very small silicone arrowhead shaped tubes It is important to note that there is increasing evidence about the benefits of minimally invasive modalities like Mini-Monaka. the non-surgical dilation can be performed as an office procedure .

Study Type

Observational

Enrollment (Actual)

100

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
      • Assiut, Egypt, 71515
        • Assiut University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients will be divided into 3 groups:

Group A: 7 patients with punctal stenosis will be treated with mini monoka. Group B: 7 patients with punctal stenosis will be treated with punctoplasty. Group C: 7 patients with punctal stenosis will be treated with perforated plug

Description

Inclusion Criteria:

  • o Confirmed unilateral or bilateral cases of punctal stenosis based on slit-lamp examination.

Exclusion Criteria:

  • o Epiphora due to distal obstruction

    • Active ocular infection or inflammation.
    • Anatomic abnormalities
    • Ocular cicatricial pemphigoid

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
Comparison between mini monaka,perforated plugs and 3-Snip punctoplasty in punctal stenosis by using slit lamp examination
Time Frame: 1 year
correlation between mini monaka, perforated plugs and punctoplasty in punctal stenosis according to improvement in tear drainage by using slit lamp examination.
1 year
Comparison between mini monaka,perforated plugs and 3-Snip punctoplasty in punctal stenosis by using fluoresceine dilution test
Time Frame: 1 year
correlation between mini monaka, perforated plugs and punctoplasty in punctal stenosis according to improvement in tear drainage by using fluoresceine dilution test
1 year

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Chair: mohamed shehata, prof, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

May 25, 2024

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

May 27, 2024

First Submitted That Met QC Criteria

June 1, 2024

First Posted (Actual)

June 6, 2024

Study Record Updates

Last Update Posted (Actual)

June 6, 2024

Last Update Submitted That Met QC Criteria

June 1, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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