Canadian Eye Injury Registry (CEIR)
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| First Received Date ICMJE | June 29, 2011 | ||||||||
| Last Updated Date | December 9, 2011 | ||||||||
| Start Date ICMJE | February 2011 | ||||||||
| Estimated Primary Completion Date | February 2016 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Number and type of eye injuries occurring in Canada [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] To record and determine the types and epidemiologic data of eye injuries in Canada. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01490593 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Ocular Trauma Score [ Time Frame: 6 months ] [ Designated as safety issue: No ] 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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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Canadian Eye Injury Registry | ||||||||
| Official Title ICMJE | Canadian Eye Injury Registry | ||||||||
| Brief Summary | The purpose of this study is to establish an eye injury registry to assess the mechanisms and outcomes of significant eye injuries occurring in Canada. The epidemiologic data will determine where public health strategies should be directed to prevent future eye injuries. |
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| 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. |
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| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Time Perspective: Prospective | ||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | All individuals who have sustained a serious eye injury in Canada. |
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| Condition ICMJE | Eye Injuries | ||||||||
| Intervention ICMJE | Behavioral: Public Health strategies
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 Name: CEIR |
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| Study Group/Cohort (s) | 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.
Intervention: Behavioral: Public Health strategies |
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| Publications * | Kuhn F, Morris R, Witherspoon CD, Mann L. Epidemiology of blinding trauma in the United States Eye Injury Registry. Ophthalmic Epidemiol. 2006 Jun;13(3):209-16. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 2500 | ||||||||
| Estimated Completion Date | February 2016 | ||||||||
| Estimated Primary Completion Date | February 2016 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Canada | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01490593 | ||||||||
| Other Study ID Numbers ICMJE | R-11-079, 17853e | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Phil Hooper, Lawson Health Research Institute | ||||||||
| Study Sponsor ICMJE | Lawson Health Research Institute | ||||||||
| Collaborators ICMJE | Canadian National Institute for the Blind | ||||||||
| Investigators ICMJE |
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| Information Provided By | Lawson Health Research Institute | ||||||||
| Verification Date | December 2011 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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