NCT03778190

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 11, 2019

Completed
10 months until next milestone

Results Posted

Study results publicly available

August 26, 2020

Completed
Last Updated

August 26, 2020

Status Verified

August 1, 2020

Enrollment Period

11 months

First QC Date

December 14, 2018

Results QC Date

August 4, 2020

Last Update Submit

August 19, 2020

Conditions

Corneal Foreign Body

Outcome Measures

Primary Outcomes (1)

  • Success Rate

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

    5 minutes.

Secondary Outcomes (1)

  • Epithelial Damage

    5 minutes

Study Arms (1)

Magnet

EXPERIMENTAL

The physician will attempt to remove the corneal foreign body using an eye magnet for these patients.

Procedure: Corneal Foreign Body Removal

Interventions

Corneal Foreign Body RemovalPROCEDURE

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.

Magnet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kendall Regional Medical Center

Miami, Florida, 33175, United States

Location

Results Point of Contact

Title
Dr. Tony Zitek
Organization
Kendall Regional Medical Center
zitek10@gmail.com
305-480-6602

Study Officials

  • Tony Zitek, MD

    Kendall Healthcare Group, Ltd.

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2018

First Posted

December 19, 2018

Study Start

December 4, 2018

Primary Completion

November 11, 2019

Study Completion

November 11, 2019

Last Updated

August 26, 2020

Results First Posted

August 26, 2020

Record last verified: 2020-08

Locations

US(1)