Three Different Modalities for Treatment of Inflammatory Punctal Stenosis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-20

Study Completion Date

2024-06-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Modalities Treatment Inflammatory Punctal Stenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A

Patients were treated with punctal dilatation only

Group Type EXPERIMENTAL

Punctal dilation

Intervention Type PROCEDURE

Patients were treated with punctal dilatation only.

Group B

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 Type EXPERIMENTAL

Punctal dilation and topical medication

Intervention Type 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.

Group C

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

Group Type EXPERIMENTAL

Triamcinolone acetonide

Intervention Type DRUG

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

Interventions

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Punctal dilation

Patients were treated with punctal dilatation only.

Intervention Type PROCEDURE

Punctal dilation and topical medication

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.

Intervention Type DRUG

Triamcinolone acetonide

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

33 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No