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

Sponsor

University Hospital, Clermont-Ferrand (Other)

Overall Status

Recruiting

CT.gov ID

NCT03706560

Collaborator

(none)

Enrollment

Location

56.4

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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.

Study Design

Study Type:

Observational

Anticipated 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 :

Jun 18, 2018

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Feb 28, 2023

Outcome Measures

Primary Outcome Measures

Professionnal status of workers after the ocular trauma telephone questionnaire) [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

Far final visual acuity [at 6 months]
Far final visual acuity with Monoyer scale (telephone questionnaire) (in decimal).
Mecanism of ocular trauma [at least 6 months after their hospitalization for ocular trauma]
traumatism by foreign body, percussion, burn, fall, other
Initial ocular lesions [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 [at 6 month]
All ocular complications that may have an impact on the final visual fonction (qualitative scale)
Proportion of work-related ocular trauma [at 6 month]
Proportion of work-related ocular trauma
Wear of protective eyewear during traumatism [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 [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 [at 6 month]
days
Variations of time of work since the ocular trauma [at 6 month]
hours per week
State of Stress and Mood at work, before and after the ocular trauma, by graduating scales (telephone questionnaire) [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) [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) [at 6 month]
by graduating scales, between 0 to 10, before and after the ocular trauma (telephone questionnaire)
Tobacco consumption [at 6 month]
number of cigarette per day, before and after the ocular trauma
Alcohol consumption [at 6 month]
before and after the ocular trauma, in number of alcohol unity per day
Consumption of pharmaceuticals [at 6 month]
type of pharmaceuticals and any modification before and after the ocular trauma
Limitations or modifications on sport [at 6 month]
by graduated scales (between 0 to 4) (telephone questionnaire)
Limitations or modifications on driving [at 6 month]
by graduated scales (between 0 to 4) (telephone questionnaire)
Limitations or modifications on hobbies [at 6 month]
by graduated scales (between 0 to 4) (telephone questionnaire)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Clermont-Ferrand	Clermont-Ferrand	Auvergne	France	63003

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

University Hospital, Clermont-Ferrand

ClinicalTrials.gov Identifier:

NCT03706560

Other Study ID Numbers:

CHU-399
2018-A00605-50

First Posted:

Oct 16, 2018

Last Update Posted:

Oct 25, 2018

Last Verified:

Oct 1, 2018

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Clermont-Ferrand

workers

eye injuries

work abilities

Additional relevant MeSH terms:

Eye Injuries

Occupational Stress

Study Results

No Results Posted as of Oct 25, 2018