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OpenTrials
Completed

NCT Number: NCT06798025

Three Different Modalities for Treatment of Inflammatory Punctal Stenosis

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)

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Key information

Age range

33 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Punctal dilation

Procedure

Patients were treated with punctal dilatation only.

Punctal dilation and topical medication

Drug

Patients were treated with a combination of punctal 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.

Triamcinolone Acetonide

Drug

Patients were treated with a peri-punctual injection of Triamcinolone acetonide.

Primary outcomes

  1. Degree of patient satisfaction

    Time frame: 3 months postoperatively

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

Secondary outcomes

  1. Punctal diameter

    Time frame: 3 months postoperatively

    The punctal diameter of cases was measured before and after 1 month and 3 months of treatment.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Comparative Study Between Three Different Modalities for Treatment of Inflammatory Punctal Stenosis

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jan 29, 2025
Registry last updated
Jan 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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