Three Different Modalities for Treatment of Inflammatory Punctal Stenosis

NCT06798025 | Completed

• 1 other identifier: 36264MS245/2/23
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Conditions

Modalities; Treatment; Inflammatory Punctal Stenosis

Outcome Measures

Primary Outcomes (1)

• Degree of patient satisfaction

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

  3 months postoperatively

Secondary Outcomes (1)

• Punctal diameter

  3 months postoperatively

Study Arms (3)

Group A

EXPERIMENTAL

Patients were treated with punctal dilatation only

Procedure: Punctal dilation

Group B

EXPERIMENTAL

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.

Drug: Punctal dilation and topical medication

Group C

EXPERIMENTAL

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

Drug: Triamcinolone acetonide

Interventions

Punctal dilation PROCEDURE

Patients were treated with punctal dilatation only.

Group A

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.

Group B

Triamcinolone acetonide DRUG

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

Group C

Eligibility Criteria

• Age: 33 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Dosage Forms; Triamcinolone Acetonide

Intervention Hierarchy (Ancestors)

Pharmaceutical Preparations; Technology, Pharmaceutical; Investigative Techniques; Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident of Ophthalmology, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: January 23, 2025
• First Posted: January 29, 2025
• Study Start: July 20, 2023
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: January 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)