Viewing Study NCT06446674



Ignite Creation Date: 2024-06-16 @ 11:50 AM
Last Modification Date: 2024-10-26 @ 3:31 PM
Study NCT ID: NCT06446674
Status: ACTIVE_NOT_RECRUITING
Last Update Posted: 2024-06-06
First Post: 2024-05-27

Brief Title: Comparison Between Mini MonakaPerforated Plugs and 3-Snip Punctoplasty in Punctal Stenosis
Sponsor: Assiut University
Organization: Assiut University

Study Overview

Official Title: Comparison Between Mini MonakaPerforated Plugs and 3-Snip Punctoplasty in Punctal Stenosis
Status: ACTIVE_NOT_RECRUITING
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 Kellys 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 Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None