Professional Consequences of Ocular Trauma Hospitalized at the Hospital Centre of Clermont-Ferrand (HOT-WORK)

October 23, 2018 updated by: University Hospital, Clermont-Ferrand

Professional Consequences of Ocular Trauma Hospitalized at the University Hospital Centre of Clermont-Ferrand

Ocular trauma are a real public health issue. According to WHO, it is estimates at 750,000 hospital admissions per year in the world for ocular trauma, including 200,000 for open globe injuries in the world. Consequences can be severe with a significant number of definitive low vision or blindness which can lead to professionnal reclassifications for active patients. However, no study exists on professional consequences of those ocular trauma. Some studies showed that fonctionnal loss of an eye can also have psychological consequences such as post traumatic depression or can impair the quality of life but studies are scarce on this subject.

The primary objective is to study the professional reclassification of workers at least 6 months after their hospitalization for ocular trauma.

Secondary objectives are to assess, at least 6 months after an hospitalized ocular trauma, characteristics of eye injuries, characteristics of patients, mid-term consequences at work after eye injury and on personal aspects.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Use of the ophthalmologic consultation report, the ophthalmologic hospitalization report and a telephone questionnaire to carry out the study.

At least 6 months after the traumatism, an ophthalmologist member of the team, M. Vincent Jawad, will call each patient for answering a telephone questionnaire after obtention of his oral consent.

If the traumatism occur after the beginning of the study, the patient will be informed, by M. Vincent Jawad, of the modalities of the study during his hospitalization and an information letter will be given to the patient in the same time (annex 2). His non opposition will be asked by telephone, remote from the hospitalization, before proceeding to the telephone questionnaire.

If the traumatism occur before the beginning of the study or if the information and non opposition letter has not been given to the patient during the hospitalization, the information letter (annex 2) will be sent by mail to the patient before the telephone call.

In all cases, the patient's consent (or non opposition) will be collected orally before proceeding to the telephone questionnaire (annex 1).

Medical data will be obtained from the medical report of hospitalization and the last report consultation of his ophthalmologist.

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Auvergne
      • Clermont-Ferrand, Auvergne, France, 63003
        • Recruiting
        • CHU de Clermont-Ferrand
        • Sub-Investigator:
          • Frédéric CHIAMBARETTA, MD, PhD
        • Sub-Investigator:
          • Vincent JAWAD, ophtalmology resident

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults, with a job, hospitalized for ocular trauma in the ophthalmology unit of the University Hospital of Clermont-ferrand from january the first of 2005 to december the 31st of 2022.

Description

Inclusion Criteria:

  • Adults, with a job
  • hospitalized for ocular trauma in the ophthalmology unit of the University Hospital of Clermont-ferrand
  • from january the first of 2005 to december the 31st of 2022.

Exclusion Criteria:

  • Patient without job at the time of the ocular traumatism
  • Refusal to participate in the study
  • Unable to answer to the telephone questionnaire (difficulties understanding, cognitive disorders…)
  • Impossibility to contact the patient

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Professionnal status of workers after the ocular trauma telephone questionnaire)
Time Frame: at 6 months
The professional status of workers at least 6 months after the ocular trauma, at the period of realization of the telephone questionnaire by questioning the patient; qualitative scale: reinstatement in the same workstation, adaptation of the workstation, change of work (in the same company or in an other one), no return to work.
at 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Far final visual acuity
Time Frame: at 6 months
Far final visual acuity with Monoyer scale (telephone questionnaire) (in decimal).
at 6 months
Mecanism of ocular trauma
Time Frame: at least 6 months after their hospitalization for ocular trauma
traumatism by foreign body, percussion, burn, fall, other
at least 6 months after their hospitalization for ocular trauma
Initial ocular lesions
Time Frame: at day 1
corneal wound, scleral wound, cataract, wounds of the lid margin, of the lacrymal ducts, hyphaema, ocular hypertension, intravitreal haemorrhage, ulceration, others
at day 1
Final ocular sequelae
Time Frame: at 6 month
All ocular complications that may have an impact on the final visual fonction (qualitative scale)
at 6 month
Proportion of work-related ocular trauma
Time Frame: at 6 month
Proportion of work-related ocular trauma
at 6 month
Wear of protective eyewear during traumatism
Time Frame: at 6 month
Wear of protective eyewear during traumatism, binary scale (yes/no)
at 6 month
Medical opinion of professional aptitude made by the occupational physician during work resumption examination
Time Frame: at 6 month
Qualitative scale (apt, unfit with professional reclassification, dismissal for professional inability with formal contraindication of job retention)
at 6 month
Total duration of Work stoppage
Time Frame: at 6 month
days
at 6 month
Variations of time of work since the ocular trauma
Time Frame: at 6 month
hours per week
at 6 month
State of Stress and Mood at work, before and after the ocular trauma, by graduating scales (telephone questionnaire)
Time Frame: at 6 month
by graduating scales, between 0 to 10, before and after the ocular trauma
at 6 month
Quality of sleep, before and after the ocular trauma by graduating scales (telephone questionnaire)
Time Frame: at 6 month
by graduating scales, between 0 to 10, before and after the ocular trauma
at 6 month
Job demand, job control and social support (derived from the Karasek questionnaire)
Time Frame: at 6 month
by graduating scales, between 0 to 10, before and after the ocular trauma (telephone questionnaire)
at 6 month
Tobacco consumption
Time Frame: at 6 month
number of cigarette per day, before and after the ocular trauma
at 6 month
Alcohol consumption
Time Frame: at 6 month
before and after the ocular trauma, in number of alcohol unity per day
at 6 month
Consumption of pharmaceuticals
Time Frame: at 6 month
type of pharmaceuticals and any modification before and after the ocular trauma
at 6 month
Limitations or modifications on sport
Time Frame: at 6 month
by graduated scales (between 0 to 4) (telephone questionnaire)
at 6 month
Limitations or modifications on driving
Time Frame: at 6 month
by graduated scales (between 0 to 4) (telephone questionnaire)
at 6 month
Limitations or modifications on hobbies
Time Frame: at 6 month
by graduated scales (between 0 to 4) (telephone questionnaire)
at 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Frédéric DUTHEIL, MD,PhD, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2018

Primary Completion (Anticipated)

December 31, 2022

Study Completion (Anticipated)

February 28, 2023

Study Registration Dates

First Submitted

July 5, 2018

First Submitted That Met QC Criteria

October 10, 2018

First Posted (Actual)

October 16, 2018

Study Record Updates

Last Update Posted (Actual)

October 25, 2018

Last Update Submitted That Met QC Criteria

October 23, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-399
  • 2018-A00605-50 (Other Identifier: 2018-A00605-50)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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