Clinical trial NCT03706560: Professional Consequences of Ocular Trauma Hospitalized at the Hospital Centre of Clermont-Ferrand
Official title: Professional Consequences of Ocular Trauma Hospitalized at the University Hospital Centre of Clermont-Ferrand
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eye Injuries
Work Performance
Occupational Stress
Keywords: workers
eye injuries
work abilities
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2018-10-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Professionnal status of workers after the ocular trauma telephone questionnaire)
timeFrame: at 6 months
Secondary outcomes:
measure: Far final visual acuity
timeFrame: at 6 months
measure: Mecanism of ocular trauma
timeFrame: at least 6 months after their hospitalization for ocular trauma
measure: Initial ocular lesions
timeFrame: at day 1
measure: Final ocular sequelae
timeFrame: at 6 month
measure: Proportion of work-related ocular trauma
timeFrame: at 6 month
measure: Wear of protective eyewear during traumatism
timeFrame: at 6 month
measure: Medical opinion of professional aptitude made by the occupational physician during work resumption examination
timeFrame: at 6 month
measure: Total duration of Work stoppage
timeFrame: at 6 month
measure: Variations of time of work since the ocular trauma
timeFrame: at 6 month
measure: State of Stress and Mood at work, before and after the ocular trauma, by graduating scales (telephone questionnaire)
timeFrame: at 6 month
measure: Quality of sleep, before and after the ocular trauma by graduating scales (telephone questionnaire)
timeFrame: at 6 month
measure: Job demand, job control and social support (derived from the Karasek questionnaire)
timeFrame: at 6 month
measure: Tobacco consumption
timeFrame: at 6 month
measure: Alcohol consumption
timeFrame: at 6 month
measure: Consumption of pharmaceuticals
timeFrame: at 6 month
measure: Limitations or modifications on sport
timeFrame: at 6 month
measure: Limitations or modifications on driving
timeFrame: at 6 month
measure: Limitations or modifications on hobbies
timeFrame: at 6 month
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
state: Auvergne
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Frédéric DUTHEIL, MD,PhD
role: PRINCIPAL_INVESTIGATOR
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