3 Snip Punctoplasty With and Without Mitomycine C.

Punctal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05586620
• Other study ID #: 3 Snip Punctoplasty
• Status: Completed
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: June 10, 2022

Study information

• Verified date: October 2022
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: June 10, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 63 Years

Eligibility

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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Punctal Stenosis

Intervention

Procedure:
• 3-snip punctoplasty
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
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

Locations

Country	Name	City	State
Egypt	Ehab tharwat	Damieta	New Damietta

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Punctal patency	Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not	Baseline
Primary	Punctal patency	Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not	1 week postoperative
Primary	Punctal patency	Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not	1 month postoperative
Primary	Punctal patency	Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not	3 months postoperative
Primary	Presence of Epiphora	It will be assessed by inspection of the lid by slitlamb examination.	Baseline
Primary	Presence of Epiphora	It will be assessed by inspection of the lid by slitlamb examination.	1 week postoperative
Primary	Presence of Epiphora	It will be assessed by inspection of the lid by slitlamb examination.	1 month postoperative
Primary	Presence of Epiphora	It will be assessed by inspection of the lid by slitlamb examination.	3 month postoperative