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Completed

NCT Number: NCT05586620

3 Snip Punctoplasty With and Without Mitomycine C.

Punctal stenosis is a progressive constriction of the puncta with resultant epiphora. One of the most effective treatment options is 1- to 4-snip punctoplasty combined with or without Mitomycin-C.

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Key information

Conditions

Punctal Stenosis

Age range

16 year–63 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ehab tharwat

Damietta, New Damietta, 34517, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with recurrence of punctal stenosis at the end of 1 month following punctal dilatation.

Exclusion criteria

  • patients with associated lacrimal passage obstruction

Treatment and study plan

3-snip punctoplasty

Procedure

punctoplasty, more commonly known as watery eye surgery, is an ophthalmic surgical procedure performed to correct punctal stenosis (a condition that causes tears to overflow from the eyes) by widening the punctal opening to allow the tears to drain with ease.

3-snip punctoplasty and Mitomycin C

Procedure

punctoplasty, more commonly known as watery eye surgery, is an ophthalmic surgical procedure performed to correct punctal stenosis (a condition that causes tears to overflow from the eyes) by widening the punctal opening to allow the tears to drain with ease.

Mitomycin C is a chemotherapeutic agent that acts by inhibiting DNA synthesis

Primary outcomes

  1. Punctal patency

    Time frame: Baseline

    Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not

  2. Punctal patency

    Time frame: 1 week postoperative

    Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not

  3. Punctal patency

    Time frame: 1 month postoperative

    Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not

  4. Punctal patency

    Time frame: 3 months postoperative

    Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not

  5. Presence of Epiphora

    Time frame: Baseline

    It will be assessed by inspection of the lid by slitlamb examination.

  6. Presence of Epiphora

    Time frame: 1 week postoperative

    It will be assessed by inspection of the lid by slitlamb examination.

  7. Presence of Epiphora

    Time frame: 1 month postoperative

    It will be assessed by inspection of the lid by slitlamb examination.

  8. Presence of Epiphora

    Time frame: 3 month postoperative

    It will be assessed by inspection of the lid by slitlamb examination.

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

Comparative Study on 3 Snip Punctoplasty With and Without Mitomycine C in the Management of Punctual Stenosis or Occlusion

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 19, 2022
Registry last updated
Oct 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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