Clinical trial NCT01490593: Canadian Eye Injury Registry
Official title: Canadian Eye Injury Registry
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Eye Injuries
Keywords: Canadian
Eye
Injury
Registry
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Canadian National Institute for the Blind
First posted: 2011-12-13
Enrollment: 104
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals who have sustained a serious eye injury in Canada.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number and type of eye injuries occurring in Canada
timeFrame: 6 months
Secondary outcomes:
measure: Ocular Trauma Score
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: Canada
facility: Ivey Eye Institute
state: Ontario
Study officials:
affiliation: The University of Western Ontario - Ivey Eye Institute
name: Philip L Hooper, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1080/09286580600665886.