Magnet for Corneal Foreign Bodies

August 19, 2020 updated by: Kendall Healthcare Group, Ltd.

The Use of a Magnet to Remove Corneal Foreign Bodies

This is a prospective, interventional study to assess the effectiveness and safety of a commercially available "eye magnet" to remove corneal foreign bodies.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The vast majority of corneal foreign bodies are metallic and thus are frequently ferromagnetic. Consequently, it may be possible to use a magnet to remove most corneal foreign bodies. There are commercially available products for removing corneal foreign bodies, but there are no published studies assessing these devices.

This will be a prospective interventional study to assess the use of an eye magnet for the removal of metallic corneal foreign bodies in the emergency department.

After the patient signs written, informed consent, the physician will attempt to remove the corneal foreign body with the North by Honeywell 326734G Eye Magnet with Loop. If the physician is unable to remove the corneal foreign body with the magnet, he or she may proceed with standard care.

The treating physician will fill out a brief data collection form for each patient to track various outcomes as discussed below.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33175
        • Kendall Regional Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • present to the emergency department with a metallic corneal foreign body

Exclusion Criteria:

  • prisoners
  • pregnant women
  • have pacemakers or metallic facial implants
  • possible globe rupture

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnet
The physician will attempt to remove the corneal foreign body using an eye magnet for these patients.
Procedure: Corneal Foreign Body Removal
An eye magnet will be brought close to the foreign body on the surface of the eye in an attempt to remove the foreign body.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success Rate
Time Frame: 5 minutes.
The percentage of patients in whom the magnet successfully removed the foreign body.
5 minutes.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epithelial Damage
Time Frame: 5 minutes
The percentage of patients in whom the amount of fluorescein uptake on exam was more after the procedure compared to before the procedure.
5 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kendall Healthcare Group, Ltd.

Collaborators

Nova Southeastern University

Investigators

  • Study Director: Tony Zitek, MD, Kendall Healthcare Group, Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2018

Primary Completion (Actual)

November 11, 2019

Study Completion (Actual)

November 11, 2019

Study Registration Dates

First Submitted

December 14, 2018

First Submitted That Met QC Criteria

December 14, 2018

First Posted (Actual)

December 19, 2018

Study Record Updates

Last Update Posted (Actual)

August 26, 2020

Last Update Submitted That Met QC Criteria

August 19, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-419-Non-NSU Health

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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