NCT06446674

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 25, 2024

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 6, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

June 6, 2024

Status Verified

June 1, 2024

Enrollment Period

10 months

First QC Date

May 27, 2024

Last Update Submit

June 1, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Comparison between mini monaka,perforated plugs and 3-Snip punctoplasty in punctal stenosis by using slit lamp examination

    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

    correlation between mini monaka, perforated plugs and punctoplasty in punctal stenosis according to improvement in tear drainage by using fluoresceine dilution test

    1 year

Interventions

mini monakaPROCEDURE

mini monaka,perforated plugs

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • o Epiphora due to distal obstruction
  • Active ocular infection or inflammation.
  • Anatomic abnormalities
  • Ocular cicatricial pemphigoid

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut university

Asyut, 71515, Egypt

Location

Related Publications (5)

  • 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.

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

  • 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.

  • 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.

  • 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.

Study Officials

  • mohamed shehata, prof

    Assiut University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmology Specialist

Study Record Dates

First Submitted

May 27, 2024

First Posted

June 6, 2024

Study Start

May 25, 2024

Primary Completion

April 1, 2025

Study Completion

September 1, 2025

Last Updated

June 6, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations