Corneal Foreign BodyNCT03778190
Magnet for Corneal Foreign Bodies
A study testing Corneal Foreign Body Removal in people with Corneal Foreign Body, run by Kendall Healthcare Group, Ltd. at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Foreign Body
- What is being tested?
- Corneal Foreign Body Removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2018to 11 Nov 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- present to the emergency department with a metallic corneal foreign body
Who cannot join
- prisoners
- pregnant women
- have pacemakers or metallic facial implants
- possible globe rupture
Trial locations and contacts
1 site in 1 country.
United States1 site
Kendall Regional Medical Center
Miami, Florida, 33175
About this study
Official title: 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.
Read the 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.
- Conditions
- Corneal Foreign Body
- Being tested
- Corneal Foreign Body Removal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal Foreign Body RemovalProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Magnet | Experimental | The physician will attempt to remove the corneal foreign body using an eye magnet for these patients. Receives: Procedure: Corneal Foreign Body Removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate
The percentage of patients in whom the magnet successfully removed the foreign body.
Measured: 5 minutes.
Secondary outcomes (1)
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.
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study start4 Dec 2018
- Primary completion11 Nov 2019
- Study completion11 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Corneal Foreign BodyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kendall Healthcare Group, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nova Southeastern University
- Responsible party
- Sponsor
- Investigators
- Tony Zitek, MD, Study director, Kendall Healthcare Group, Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03778190
- Sponsor's protocol ID
- 2018-419-Non-NSU Health
- Status last verified
- Aug 2020
- First submitted
- 14 Dec 2018
- Last updated
- 26 Aug 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Magnet to Remove Corneal Foreign Bodies
- ClinicalTrials.gov ID
- NCT03778190
- Acronym / sponsor ID
- 2018-419-Non-NSU Health
- Conditions
- Corneal Foreign Body
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Kendall Healthcare Group, Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Nova Southeastern University
- Study start
- 4 Dec 2018 (actual)
- Primary completion
- 11 Nov 2019 (actual)
- Study completion
- 11 Nov 2019 (actual)
- First posted
- 19 Dec 2018 (actual)
- Results
- Posted 26 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, interventional study to assess the effectiveness and safety of a commercially available "eye magnet" to remove corneal foreign bodies.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Magnet | Experimental | Procedure: Corneal Foreign Body RemovalThe physician will attempt to remove the corneal foreign body using an eye magnet for these patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- present to the emergency department with a metallic corneal foreign body
Key exclusion criteria (4 listed)
- prisoners
- pregnant women
- have pacemakers or metallic facial implants
- possible globe rupture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Corneal Foreign Body RemovalAn eye magnet will be brought close to the foreign body on the surface of the eye in an attempt to remove the foreign body. | Procedure or surgery | Magnet |
Primary outcome
Success Rate
Time frame: 5 minutes.
The percentage of patients in whom the magnet successfully removed the foreign body.
1 secondary outcome
Epithelial Damage
Time frame: 5 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tony Zitek, MD study director
Kendall Healthcare Group, Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Corneal Foreign Body Removal in people with Corneal Foreign Body, run by Kendall Healthcare Group, Ltd. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate (time frame: 5 minutes.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2020.