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
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|
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|
|Estimated Enrollment :||50 participants|
|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|
- 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.
- Far final visual acuity [ Time Frame: at 6 months ]Far final visual acuity with Monoyer scale (telephone questionnaire) (in decimal).
- Mecanism of ocular trauma [ Time Frame: at least 6 months after their hospitalization for ocular trauma ]traumatism by foreign body, percussion, burn, fall, other
- 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
- Final ocular sequelae [ Time Frame: at 6 month ]All ocular complications that may have an impact on the final visual fonction (qualitative scale)
- Proportion of work-related ocular trauma [ Time Frame: at 6 month ]Proportion of work-related ocular trauma
- Wear of protective eyewear during traumatism [ Time Frame: at 6 month ]Wear of protective eyewear during traumatism, binary scale (yes/no)
- 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)
- Total duration of Work stoppage [ Time Frame: at 6 month ]days
- Variations of time of work since the ocular trauma [ Time Frame: at 6 month ]hours per week
- 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
- 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
- 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)
- Tobacco consumption [ Time Frame: at 6 month ]number of cigarette per day, before and after the ocular trauma
- Alcohol consumption [ Time Frame: at 6 month ]before and after the ocular trauma, in number of alcohol unity per day
- Consumption of pharmaceuticals [ Time Frame: at 6 month ]type of pharmaceuticals and any modification before and after the ocular trauma
- Limitations or modifications on sport [ Time Frame: at 6 month ]by graduated scales (between 0 to 4) (telephone questionnaire)
- Limitations or modifications on driving [ Time Frame: at 6 month ]by graduated scales (between 0 to 4) (telephone questionnaire)
- Limitations or modifications on hobbies [ Time Frame: at 6 month ]by graduated scales (between 0 to 4) (telephone questionnaire)
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
|Contact: Lise LACLAUTRE||04 73 75 49 email@example.com|
|CHU de Clermont-Ferrand||Recruiting|
|Clermont-Ferrand, Auvergne, France, 63003|
|Contact: Lise LACLAUTRE 04 73 75 49 63 firstname.lastname@example.org|
|Principal Investigator: Frédéric DUTHEIL, MD, PhD|
|Sub-Investigator: Frédéric CHIAMBARETTA, MD, PhD|
|Sub-Investigator: Vincent JAWAD, ophtalmology resident|
|Principal Investigator:||Frédéric DUTHEIL, MD,PhD||University Hospital, Clermont-Ferrand|