- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01490593
Canadian Eye Injury Registry (CEIR)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Currently there is no established database or recording system of eye injuries occurring in Canada. Estimates place the figure at approximately 100000 significant eye injuries occurring in our country every year. This represents a large public health and long-term disability challenge. Lost productivity of working-age individuals with vision loss amounts to $4.4 billion annually in Canada, part of which is due to eye injury. By recording the types, locations, and outcomes of significant eye injuries, it is hoped improved public health strategies may be established to prevent further ones. The need for such a database has been recognized by the Ivey Eye Institute, the Canadian National Institute for the Blind (CNIB) and the Canadian Ophthalmological Society (COS).
The United States Eye Injury Registry (USEIR) has been in existence for greater than 20 years. Through their database they have recorded thousands of eye injuries which has led to public health interventions through their various ocular societies. They have also established a standardized reporting system and ocular trauma score which has improved diagnosis and prognosis of eye injuries. This system has been used in many countries as a standardized reporting scheme for eye injuries.
It is hoped that through a pilot recording system established in London a framework for a national reporting system will develop. The objective is to use the standardized reporting system of the USEIR to report Canadian eye injuries.
The time frame for outcome measures will be 6 months. The patients will be followed along for this amount of time to assess there visual outcomes. No further follow up after 6 months will be undertaken for the purpose of the registry.
The hypothesis is that by recording the type and outcome of eye injuries, a better understanding of mechanisms and location of these injuries in Canada will occur. Subsequent public health interventions can then be made in conjunction with the CNIB and COS to improve eye health in Canada.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Ontario
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London, Ontario, Canada, N6A 4V2
- Ivey Eye Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Any patient who experiences an acute eye injury that has or has the potential to compromise the integrity of the eye. These are serious eye injuries resulting in permanent and significant (i.e. measurable or observable on routine eye examination) structural or functional change to the eye. Separate reports are to be filed for each eye involved in bilateral injuries.
Exclusion Criteria:
- Based on the standard of the United States Eye Injury Registry
- Mild ocular contusions
- Subconjunctival hemorrhage
- Superficial abrasions by themselves usually would not meet the criterion of serious and/or reportable injuries.
- The exclusion of these injuries will depend on the clinical judgement of the reporting physician.
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Patients with Eye Injuries
The database is being established to record the number and types of eye injuries occurring in Canada.
Thus there is only one cohort group, individuals who have sustained an eye injury.
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It is hoped that by recording of the data (i.e.
locations and mechanisms of eye injuries), we may be able to develop public health strategies to prevent further injuries.
For example, encouraging more visor wear in hockey games if we notice increased prevalence of hockey eye injuries with no visor.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number and type of eye injuries occurring in Canada
Time Frame: 6 months
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To record and determine the types and epidemiologic data of eye injuries in Canada.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ocular Trauma Score
Time Frame: 6 months
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To determine the correlation between the ocular trauma score as defined by the American Society of Ocular Trauma and the actual visual outcomes of Canadian Eye Injury patients
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6 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Philip L Hooper, MD, The University of Western Ontario - Ivey Eye Institute
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R-11-079
- 17853e (Other Identifier: REB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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