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

Active, not recruiting

• Conditions: Punctal Stenosis

• Registration Number: NCT06446674
• Lead Sponsor: Assiut University

Brief Summary

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

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 Timeline

• Study Start: 2024-05-25
• Study First Submitted: 2024-05-27
• Status Verified: 2024-06
• Study First Submitted QC: 2024-06-01
• Last Update Submitted: 2024-06-01
• Study First Posted: 2024-06-06
• Last Update Posted: 2024-06-06
• Primary Completion: 2025-04-01
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt