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

NCT ID: NCT06446674

Last Updated: 2024-06-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-25
• Study Completion Date: 2025-09-30

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 .

Conditions

Punctal Stenosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

mini monaka

mini monaka,perforated plugs

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Almoatz bellah zohier Mohammed

Ophthalmology Specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

mohamed shehata, prof

Role: STUDY_CHAIR

Assiut University

Locations

Assiut university

Asyut, , Egypt

Countries

Egypt

References

Atkova EL, Maydanova AA, Krakhovetskiy NN, Reznikova LV. [Punctal stenosis: etiology, diagnosis, treatment]. Vestn Oftalmol. 2022;138(2):100-107. doi: 10.17116/oftalma2022138021100. Russian.

Reference Type: RESULT

PMID: 35488568 (View on PubMed)

Bukhari AA. Management options of acquired punctal stenosis. Saudi Med J. 2013 Aug;34(8):785-92.

Reference Type: RESULT

PMID: 23974448 (View on PubMed)

Tawfik HA, Ali MJ. A major review of punctal stenosis: Updated anatomy, epidemiology, etiology, and clinical presentation. Surv Ophthalmol. 2024 May-Jun;69(3):441-455. doi: 10.1016/j.survophthal.2024.02.001. Epub 2024 Feb 8.

Reference Type: RESULT

PMID: 38336342 (View on PubMed)

Mansur C, Pfeiffer ML, Esmaeli B. Evaluation and Management of Chemotherapy-Induced Epiphora, Punctal and Canalicular Stenosis, and Nasolacrimal Duct Obstruction. Ophthalmic Plast Reconstr Surg. 2017 Jan/Feb;33(1):9-12. doi: 10.1097/IOP.0000000000000745.

Reference Type: RESULT

PMID: 27429222 (View on PubMed)

Elbakary MA. Management of Bi-Punctal Stenosis by One-Snip Punctoplasty Combined with Silicone Intubation. Orbit. 2022 Jun;41(3):324-328. doi: 10.1080/01676830.2021.1904424. Epub 2021 Mar 29.

Reference Type: RESULT

PMID: 33781149 (View on PubMed)

Other Identifiers

PS

Identifier Type: -

Identifier Source: org_study_id