Canadian Eye Injury Registry (CEIR)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by Lawson Health Research Institute
Sponsor:
Collaborator:
Canadian National Institute for the Blind
Information provided by (Responsible Party):
Phil Hooper, Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT01490593
First received: June 29, 2011
Last updated: December 9, 2011
Last verified: December 2011
  Purpose

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.


Condition Intervention
Eye Injuries
Behavioral: Public Health strategies

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Canadian Eye Injury Registry

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 2500
Study Start Date: February 2011
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All individuals who have sustained a serious eye injury in Canada.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01490593

Contacts
Contact: Teresa Jantzi 519-685-8500 ext 52492 Teresa.Jantzi@LHSC.ON.CA
Contact: David V Dudok, BA, MD 519-200-7329 ddudok2009@meds.uwo.ca

Locations
Canada, Ontario
Ivey Eye Institute Recruiting
London, Ontario, Canada, N6A 4V2
Contact: Teresa Jantzi    519-685-8500 ext 52492    Teresa.Jantzi@LHSC.ON.CA   
Principal Investigator: Philip L Hooper, MD         
Sponsors and Collaborators
Lawson Health Research Institute
Canadian National Institute for the Blind
Investigators
Principal Investigator: Philip L Hooper, MD The University of Western Ontario - Ivey Eye Institute
  More Information

Publications:
Responsible Party: Phil Hooper, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT01490593     History of Changes
Other Study ID Numbers: R-11-079, 17853e
Study First Received: June 29, 2011
Last Updated: December 9, 2011
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Canadian
Eye
Injury
Registry

Additional relevant MeSH terms:
Eye Injuries
Wounds and Injuries
Eye Diseases
Facial Injuries
Craniocerebral Trauma

ClinicalTrials.gov processed this record on July 22, 2014