Back to results3 Snip Punctoplasty With and Without Mitomycine C.
Primary Purpose
Punctal Stenosis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
3-snip punctoplasty
3-snip punctoplasty and Mitomycin C
Sponsored by
About this trial
This is an interventional treatment trial for Punctal Stenosis
Eligibility Criteria
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
Sites / Locations
- Ehab tharwat
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
3-snip punctoplasty
3-snip punctoplasty with mitomycin C
Arm Description
Outcomes
Primary Outcome Measures
Punctal patency
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
Punctal patency
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
Punctal patency
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
Punctal patency
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
Presence of Epiphora
It will be assessed by inspection of the lid by slitlamb examination.
Presence of Epiphora
It will be assessed by inspection of the lid by slitlamb examination.
Presence of Epiphora
It will be assessed by inspection of the lid by slitlamb examination.
Presence of Epiphora
It will be assessed by inspection of the lid by slitlamb examination.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05586620
Brief Title
3 Snip Punctoplasty With and Without Mitomycine C.
Official Title
Comparative Study on 3 Snip Punctoplasty With and Without Mitomycine C in the Management of Punctual Stenosis or Occlusion
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
June 10, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Al-Azhar University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Punctal Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3-snip punctoplasty
Arm Type
Active Comparator
Arm Title
3-snip punctoplasty with mitomycin C
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
3-snip punctoplasty
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
3-snip punctoplasty and Mitomycin C
Intervention Description
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 Outcome Measure Information:
Title
Punctal patency
Description
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
Time Frame
Baseline
Title
Punctal patency
Description
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
Time Frame
1 week postoperative
Title
Punctal patency
Description
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
Time Frame
1 month postoperative
Title
Punctal patency
Description
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
Time Frame
3 months postoperative
Title
Presence of Epiphora
Description
It will be assessed by inspection of the lid by slitlamb examination.
Time Frame
Baseline
Title
Presence of Epiphora
Description
It will be assessed by inspection of the lid by slitlamb examination.
Time Frame
1 week postoperative
Title
Presence of Epiphora
Description
It will be assessed by inspection of the lid by slitlamb examination.
Time Frame
1 month postoperative
Title
Presence of Epiphora
Description
It will be assessed by inspection of the lid by slitlamb examination.
Time Frame
3 month postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
63 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Ehab tharwat
City
Damieta
State/Province
New Damietta
ZIP/Postal Code
34517
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
3 Snip Punctoplasty With and Without Mitomycine C.
We'll reach out to this number within 24 hrs