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

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ClinicalTrials.gov Identifier: NCT03706560
Recruitment Status : Recruiting
First Posted : October 16, 2018
Last Update Posted : October 25, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Brief Summary:

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.


Condition or disease
Eye Injuries Work Performance Occupational Stress

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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Professional Consequences of Ocular Trauma Hospitalized at the University Hospital Centre of Clermont-Ferrand
Actual Study Start Date : June 18, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : February 28, 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Far final visual acuity [ Time Frame: at 6 months ]
    Far final visual acuity with Monoyer scale (telephone questionnaire) (in decimal).

  2. Mecanism of ocular trauma [ Time Frame: at least 6 months after their hospitalization for ocular trauma ]
    traumatism by foreign body, percussion, burn, fall, other

  3. 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

  4. Final ocular sequelae [ Time Frame: at 6 month ]
    All ocular complications that may have an impact on the final visual fonction (qualitative scale)

  5. Proportion of work-related ocular trauma [ Time Frame: at 6 month ]
    Proportion of work-related ocular trauma

  6. Wear of protective eyewear during traumatism [ Time Frame: at 6 month ]
    Wear of protective eyewear during traumatism, binary scale (yes/no)

  7. 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)

  8. Total duration of Work stoppage [ Time Frame: at 6 month ]
    days

  9. Variations of time of work since the ocular trauma [ Time Frame: at 6 month ]
    hours per week

  10. 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

  11. 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

  12. 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)

  13. Tobacco consumption [ Time Frame: at 6 month ]
    number of cigarette per day, before and after the ocular trauma

  14. Alcohol consumption [ Time Frame: at 6 month ]
    before and after the ocular trauma, in number of alcohol unity per day

  15. Consumption of pharmaceuticals [ Time Frame: at 6 month ]
    type of pharmaceuticals and any modification before and after the ocular trauma

  16. Limitations or modifications on sport [ Time Frame: at 6 month ]
    by graduated scales (between 0 to 4) (telephone questionnaire)

  17. Limitations or modifications on driving [ Time Frame: at 6 month ]
    by graduated scales (between 0 to 4) (telephone questionnaire)

  18. Limitations or modifications on hobbies [ Time Frame: at 6 month ]
    by graduated scales (between 0 to 4) (telephone questionnaire)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03706560


Contacts
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Contact: Lise LACLAUTRE 04 73 75 49 63 drci@chu-clermontferrand.fr

Locations
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France
CHU de Clermont-Ferrand Recruiting
Clermont-Ferrand, Auvergne, France, 63003
Contact: Lise LACLAUTRE    04 73 75 49 63    drci@chu-clermontferrand.fr   
Principal Investigator: Frédéric DUTHEIL, MD, PhD         
Sub-Investigator: Frédéric CHIAMBARETTA, MD, PhD         
Sub-Investigator: Vincent JAWAD, ophtalmology resident         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Frédéric DUTHEIL, MD,PhD University Hospital, Clermont-Ferrand
Publications:

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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03706560    
Other Study ID Numbers: CHU-399
2018-A00605-50 ( Other Identifier: 2018-A00605-50 )
First Posted: October 16, 2018    Key Record Dates
Last Update Posted: October 25, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
workers
eye injuries
work abilities
Additional relevant MeSH terms:
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Eye Injuries
Occupational Stress
Occupational Diseases
Stress, Psychological
Behavioral Symptoms
Facial Injuries
Craniocerebral Trauma
Trauma, Nervous System
Nervous System Diseases
Eye Diseases
Wounds and Injuries