Clinical trial NCT06446674: Comparison Between Mini Monaka,Perforated Plugs and 3-Snip Punctoplasty in Punctal Stenosis
Official title: Comparison Between Mini Monaka,Perforated Plugs and 3-Snip Punctoplasty in Punctal Stenosis.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Punctal Stenosis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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 .

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

Primary outcomes:
measure: Comparison between mini monaka,perforated plugs and 3-Snip punctoplasty in punctal stenosis by using slit lamp examination
timeFrame: 1 year
measure: Comparison between mini monaka,perforated plugs and 3-Snip punctoplasty in punctal stenosis by using fluoresceine dilution test
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut university
Study officials:
affiliation: Assiut University
name: mohamed shehata, prof
role: STUDY_CHAIR
References:
citation: 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.
citation: Bukhari AA. Management options of acquired punctal stenosis. Saudi Med J. 2013 Aug;34(8):785-92.
citation: 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.
citation: 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.
citation: 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.