OCT Guided Punctal Stenosis Management

NCT ID: NCT04318652

Last Updated: 2020-03-24

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

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-02

Study Completion Date

2019-09-20

Brief Summary

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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

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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.

Conditions

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Epiphora Due to Insufficient Drainage

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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

Group Type OTHER

Methylprednisolone eyedrops

Intervention Type DRUG

instillation of methylprednisolone eye drops

distilled water eyedrops

Distilled water eyedrops instilled 3 times per day for two weeks

Group Type PLACEBO_COMPARATOR

Methylprednisolone eyedrops

Intervention Type DRUG

instillation of methylprednisolone eye drops

Interventions

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Methylprednisolone eyedrops

instillation of methylprednisolone eye drops

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Amr Mahmoud Awara

assistant professor of ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Amr Awara

Tanta, Gharbeyia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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32399/09/18

Identifier Type: -

Identifier Source: org_study_id

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