3 Snip Punctoplasty With and Without Mitomycine C.
Comparative Study on 3 Snip Punctoplasty With and Without Mitomycine C in the Management of Punctual Stenosis or Occlusion
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 10, 2022
CompletedFirst Submitted
Initial submission to the registry
October 15, 2022
CompletedFirst Posted
Study publicly available on registry
October 19, 2022
CompletedOctober 19, 2022
October 1, 2022
1 year
October 15, 2022
October 15, 2022
Conditions
Outcome Measures
Primary Outcomes (8)
Punctal patency
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
Baseline
Punctal patency
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
1 week postoperative
Punctal patency
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
1 month postoperative
Punctal patency
Punctum will be assessed by inspection of the lid by slitlamb examination, whither obstructed or not
3 months postoperative
Presence of Epiphora
It will be assessed by inspection of the lid by slitlamb examination.
Baseline
Presence of Epiphora
It will be assessed by inspection of the lid by slitlamb examination.
1 week postoperative
Presence of Epiphora
It will be assessed by inspection of the lid by slitlamb examination.
1 month postoperative
Presence of Epiphora
It will be assessed by inspection of the lid by slitlamb examination.
3 month postoperative
Study Arms (2)
3-snip punctoplasty
ACTIVE COMPARATOR3-snip punctoplasty with mitomycin C
ACTIVE COMPARATORInterventions
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.
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
Eligibility Criteria
You may qualify if:
- Patients with recurrence of punctal stenosis at the end of 1 month following punctal dilatation.
You may not qualify if:
- patients with associated lacrimal passage obstruction
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ehab tharwat
Damietta, New Damietta, 34517, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 15, 2022
First Posted
October 19, 2022
Study Start
June 1, 2021
Primary Completion
June 1, 2022
Study Completion
June 10, 2022
Last Updated
October 19, 2022
Record last verified: 2022-10