Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03778190
Other study ID # 2018-419-Non-NSU Health
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 4, 2018
Est. completion date November 11, 2019

Study information

Verified date August 2020
Source Kendall Healthcare Group, Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date November 11, 2019
Est. primary completion date November 11, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Kendall Regional Medical Center Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
Kendall Healthcare Group, Ltd. Nova Southeastern University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Success Rate The percentage of patients in whom the magnet successfully removed the foreign body. 5 minutes.
Secondary Epithelial Damage 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