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

Occupational Stress Clinical Trial

— HOT-WORK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03706560
• Other study ID #: CHU-399
• Secondary ID: 2018-A00605-50
• Status: Recruiting
• Start date: June 18, 2018
• Est. completion date: February 28, 2023

Study information

• Verified date: October 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: Lise LACLAUTRE
• Phone: 04 73 75 49 63
• Email: drci[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 28, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Eye Injuries
• Occupational Stress
• Work Performance

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand	Auvergne

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

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