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Clinical Trials/NCT04318652
NCT04318652
Completed
Phase 4

The Role of Anterior Segment Optical Coherence Tomography in Management of Acquired Punctal Stenosis

Tanta University1 site in 1 country80 target enrollmentSeptember 2, 2018

Overview

Phase
Phase 4
Intervention
Methylprednisolone eyedrops
Conditions
Epiphora Due to Insufficient Drainage
Sponsor
Tanta University
Enrollment
80
Locations
1
Primary Endpoint
punctal opening
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2, 2018
End Date
September 20, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amr Mahmoud Awara

assistant professor of ophthalmology

Tanta University

Eligibility Criteria

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.

Arms & Interventions

Methylprednisolone eye drops

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

Intervention: Methylprednisolone eyedrops

distilled water eyedrops

Distilled water eyedrops instilled 3 times per day for two weeks

Intervention: Methylprednisolone eyedrops

Outcomes

Primary Outcomes

punctal opening

Time Frame: one month

evaluation of punctalopening by OCT

Study Sites (1)

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