Canadian Eye Injury Registry

Eye Injuries Clinical Trial

— CEIR  

Official title:

Canadian Eye Injury Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01490593
• Other study ID #: R-11-079
• Secondary ID: 17853e
• Status: Completed
• Phase: N/A
• First received: June 29, 2011
• Last updated: November 1, 2017
• Start date: March 2, 2011
• Est. completion date: January 31, 2015

Study information

• Verified date: November 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: January 31, 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Eye Injuries
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
Canada	Ivey Eye Institute	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Canadian National Institute for the Blind

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and type of eye injuries occurring in Canada	To record and determine the types and epidemiologic data of eye injuries in Canada.	6 months
Secondary	Ocular Trauma Score	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	6 months