Magnet for Corneal Foreign Bodies

• Sponsor: Kendall Healthcare Group, Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03778190
• Collaborator: Nova Southeastern University (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 11.2
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Corneal Foreign Body	Procedure: Corneal Foreign Body Removal	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Use of a Magnet to Remove Corneal Foreign Bodies
• Actual Study Start Date: Dec 4, 2018
• Actual Primary Completion Date: Nov 11, 2019
• Actual Study Completion Date: Nov 11, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Success Rate [5 minutes.]

   The percentage of patients in whom the magnet successfully removed the foreign body.

Secondary Outcome Measures

1. Epithelial Damage [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kendall Regional Medical Center	Miami	Florida	United States	33175

Sponsors and Collaborators

• Kendall Healthcare Group, Ltd.
• Nova Southeastern University

Investigators

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

Study Documents (Full-Text)

• Study Protocol - Nov 15, 2018

More Information

Publications

None provided.

• Responsible Party: Kendall Healthcare Group, Ltd.
• ClinicalTrials.gov Identifier: NCT03778190
• Other Study ID Numbers: 2018-419-Non-NSU Health
• First Posted: Dec 19, 2018
• Last Update Posted: Aug 26, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Eye Foreign Bodies; Foreign Bodies

Study Results

Participant Flow

Arm/Group Title	Magnet
Arm/Group Description	The physician will attempt to remove the corneal foreign body using an eye magnet for these patients. 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.
Period Title: Overall Study
STARTED	10
COMPLETED	10
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Magnet
Arm/Group Description	The physician will attempt to remove the corneal foreign body using an eye magnet for these patients. 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.
Overall Participants	10
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 100%
>=65 years	0 0%
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	10 100%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (Count of Participants)
United States	10 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Magnet
Arm/Group Description	The physician will attempt to remove the corneal foreign body using an eye magnet for these patients. 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.
Measure Participants	10
Count of Participants [Participants]	1 10%

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Magnet
Arm/Group Description	The physician will attempt to remove the corneal foreign body using an eye magnet for these patients. 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.
Measure Participants	10
Count of Participants [Participants]	0 0%

Adverse Events

Time Frame	10 minutes
Arm/Group Title	Magnet
Arm/Group Description	The physician will attempt to remove the corneal foreign body using an eye magnet for these patients. 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.
All Cause Mortality
	Magnet
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Serious Adverse Events
	Magnet
	Affected / at Risk (%)	# Events
Total	0/10 (0%)
Other (Not Including Serious) Adverse Events
	Magnet
	Affected / at Risk (%)	# Events
Total	0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.