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| Name | Class |
|---|---|
| Nova Southeastern University | OTHER |
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This is a prospective, interventional study to assess the effectiveness and safety of a commercially available "eye magnet" to remove corneal foreign bodies.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnet | Experimental | The physician will attempt to remove the corneal foreign body using an eye magnet for these patients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corneal Foreign Body Removal | Procedure | 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 | Description | Time Frame |
|---|---|---|
| Success Rate | The percentage of patients in whom the magnet successfully removed the foreign body. | 5 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tony Zitek, MD | Kendall Healthcare Group, Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kendall Regional Medical Center | Miami | Florida | 33175 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Magnet | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Magnet | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Success Rate | The percentage of patients in whom the magnet successfully removed the foreign body. | Posted | Count of Participants | Participants | 5 minutes. |
|
|
10 minutes
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Magnet | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Tony Zitek | Kendall Regional Medical Center | 305-480-6602 | zitek10@gmail.com |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 15, 2018 | Aug 19, 2020 | Prot_000.pdf |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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. | Posted | Count of Participants | Participants | 5 minutes |
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| 10 |
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| 10 |
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