Three Different Modalities for Treatment of Inflammatory Punctal Stenosis

Not Applicable

Completed

• Conditions: Modalities; Treatment; Inflammatory Punctal Stenosis
• Interventions: Procedure: Punctal dilation; Drug: Punctal dilation and topical medication; Drug: Triamcinolone acetonide

• Registration Number: NCT06798025
• Lead Sponsor: Tanta University

Brief Summary

This study aimed to compare the efficacy of three various modalities of treatment of inflammatory punctal stenosis (Punctal dilatation alone, combined punctal dilatation with topical medications, or peri-punctal injection of Triamcinolone acetonide)

Detailed Description

Acquired punctal stenosis is a condition in which the external opening of the lacrimal canaliculus, located in the nasal part of the palpebral margin, is narrowed or occluded. This condition results from chronic inflammation of the external punctum, leading to gradual fibrotic changes in the ostium, followed by progressive occlusion of the duct.

Different modalities were described for the treatment of acquired punctual stenosis. Repeated dilatation of the stenotic punctum is a simple procedure that may provide temporary improvement of the symptoms, but restenosis is common unless additional procedures are performed. Many other methods were used to augment punctual size, including 1-snip, 2-snip, and 3-snip punctoplasty, supplemented with adding sutures or Mini-Monoka insertion and punch punctoplasty.

Study Timeline

• Study Start: 2023-07-20
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30
• Status Verified: 2025-01
• Study First Submitted: 2025-01-23
• Study First Submitted QC: 2025-01-23
• Last Update Submitted: 2025-01-23
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Age from 33 to 75.
• Both sexes.
• Patients with inflammatory punctal stenosis or occlusion complaining of symptomatic epiphora.

Exclusion Criteria

• Subjects with previous lacrimal surgeries.
• Subjects with lid margin malposition such as ectropion, entropion, or lid retraction.
• Subjects with medial lid masses obscuring the punctum.
• Subjects with a history of ocular trauma involving the medial aspect of the lid margin.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A	Punctal dilation	Patients were treated with punctal dilatation only
Group B	Punctal dilation and topical medication	Patients were treated with a combination of punctual dilation and topical medication in the form of preservative-free steroid eye drops based on dexamethasone sodium phosphate (0.1%) and preservative-free artificial tears based on sodium hyaluronate, polyethylene, and propylene Glycol.
Group C	Triamcinolone acetonide	Patients were treated with a peri-punctual injection of Triamcinolone acetonide.

Primary Outcome Measures

Name	Time	Method
Degree of patient satisfaction	3 months postoperatively	The degree of patient satisfaction was assessed using 3-point Likert Scale (1=Not satisfied, 2: No Difference, 3:Satisfied)

Secondary Outcome Measures

Name	Time	Method
Punctal diameter	3 months postoperatively	The punctal diameter of cases was measured before and after 1 month and 3 months of treatment.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt