OCT Guided Punctal Stenosis Management

Phase 4

Completed

• Conditions: Epiphora Due to Insufficient Drainage
• Interventions: Drug: Methylprednisolone eyedrops

• Registration Number: NCT04318652
• Lead Sponsor: Tanta University

Brief Summary

This is a clinical trial study that was conducted on patients with punctal stenosis.We studied the diameter of stenosed puncta before and after treatment with preserved free steroid eye drops using AS-OCT.

Detailed Description

The study was conducted on 40 eyes of 24 patients have acquired inflammatory punctal stenosis and 20 eyes of 10 patients of normal asymptomatic subjects as control group. We studied the external punctal diameter, visibility of the internal punctum and punctal depth before treatment using AS-OCT, and then patients were re-evaluated after one month of treatment with preservative free methylprednisolone 5% eye drops.

Study Timeline

• Study Start: 2018-09-02
• Primary Completion: 2019-09-05
• Study Completion: 2019-09-20
• Status Verified: 2020-03
• Study First Submitted: 2020-03-15
• Study First Submitted QC: 2020-03-23
• Last Update Submitted: 2020-03-23
• Study First Posted: 2020-03-24
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Patients have acquired inflammatory punctum stenosis complaining of epiphora of different etiologies.

Exclusion Criteria

• Previous lacrimal surgery.
• Lid margin malposition such as ectropion, entropion or lid retraction.
• Medial lid masses obscuring punctum.
• History of ocular trauma involving lid margin or punctum.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylprednisolone eye drops	Methylprednisolone eyedrops	Preservative free steroids methylprednisolone 5% eye drops (prepared by dilution of methyleprednisolone 500mg in 10 ml distilled water (Solu-Medrol, Pfizer company) was prepared and given for all enrolled cases by the following regimen 5 times/day for 5 days with gradual decrease every third day over the following 2 weeks
distilled water eyedrops	Methylprednisolone eyedrops	Distilled water eyedrops instilled 3 times per day for two weeks

Primary Outcome Measures

Name	Time	Method
punctal opening	one month	evaluation of punctalopening by OCT

Trial Locations

Locations (1)

Amr Awara; 🇪🇬 Tanta, Gharbeyia, Egypt