3 Snip Punctoplasty With and Without Mitomycine C.

Study Overview
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Brief Summary
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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.

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

Conditions
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Punctal Stenosis

Intervention / Treatment
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* Procedure: 3-snip punctoplasty
* Procedure: 3-snip punctoplasty and Mitomycin C


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 63 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 3-snip punctoplasty<br> | Procedure: 3-snip punctoplasty<br>* 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.<br>|
| Active Comparator: 3-snip punctoplasty with mitomycin C<br> | Procedure: 3-snip punctoplasty and Mitomycin C<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |