CClinicalTrials.gg
Status unknownNCT03706560HOT-WORKUpdated Oct 25, 2018

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

An observational study in Eye Injuries, Work Performance and Occupational Stress, sponsored by University Hospital, Clermont-Ferrand. Status unknown at 1 site in France. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2018-10-25.

Sponsored by University Hospital, Clermont-Ferrand · Observational

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Eye Injuries
  • Work Performance
  • Occupational Stress

Keywords

  • workers
  • eye injuries
  • work abilities
03

In context

Eye Injuries

23 studies on the registry are indexed under Eye Injuries; 2 are open to participants now.

This study's planned enrollment of 50 is below the median of 91 across 14 observational studies indexed under Eye Injuries.

Browse Eye Injuries studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
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.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: at 6 months

Secondary outcomes

  1. Far final visual acuity

    Far final visual acuity with Monoyer scale (telephone questionnaire) (in decimal).

    Time frame: at 6 months

  2. Mecanism of ocular trauma

    traumatism by foreign body, percussion, burn, fall, other

    Time frame: at least 6 months after their hospitalization for ocular trauma

  3. Initial ocular lesions

    corneal wound, scleral wound, cataract, wounds of the lid margin, of the lacrymal ducts, hyphaema, ocular hypertension, intravitreal haemorrhage, ulceration, others

    Time frame: at day 1

  4. Final ocular sequelae

    All ocular complications that may have an impact on the final visual fonction (qualitative scale)

    Time frame: at 6 month

  5. Proportion of work-related ocular trauma

    Proportion of work-related ocular trauma

    Time frame: at 6 month

  6. Wear of protective eyewear during traumatism

    Wear of protective eyewear during traumatism, binary scale (yes/no)

    Time frame: at 6 month

  7. 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)

    Time frame: at 6 month

  8. Total duration of Work stoppage

    days

    Time frame: at 6 month

  9. Variations of time of work since the ocular trauma

    hours per week

    Time frame: at 6 month

  10. 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

    Time frame: at 6 month

  11. 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

    Time frame: at 6 month

  12. 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)

    Time frame: at 6 month

  13. Tobacco consumption

    number of cigarette per day, before and after the ocular trauma

    Time frame: at 6 month

  14. Alcohol consumption

    before and after the ocular trauma, in number of alcohol unity per day

    Time frame: at 6 month

  15. Consumption of pharmaceuticals

    type of pharmaceuticals and any modification before and after the ocular trauma

    Time frame: at 6 month

  16. Limitations or modifications on sport

    by graduated scales (between 0 to 4) (telephone questionnaire)

    Time frame: at 6 month

  17. Limitations or modifications on driving

    by graduated scales (between 0 to 4) (telephone questionnaire)

    Time frame: at 6 month

  18. Limitations or modifications on hobbies

    by graduated scales (between 0 to 4) (telephone questionnaire)

    Time frame: at 6 month

07

Study locations

1 of 1 sites recruiting
  • CHU de Clermont-Ferrand
    Clermont-Ferrand, Auvergne 63003, France
    • Lise LACLAUTRE · Contact · drci@chu-clermontferrand.fr · 04 73 75 49 63
    • Frédéric DUTHEIL, MD, PhD · Principal investigator
    • Frédéric CHIAMBARETTA, MD, PhD · Sub investigator
    • Vincent JAWAD, ophtalmology resident · Sub investigator
    Recruiting
08

References and documents

Publications

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  • Pinna A, Atzeni G, Patteri P, Salvo M, Zanetti F, Carta F. Epidemiology, visual outcome, and hospitalization costs of open globe injury in northern Sardinia, Italy. Ophthalmic Epidemiol. 2007 Sep-Oct;14(5):299-305. doi: 10.1080/09286580701198753. PubMed 17994439 ↗
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  • Casson RJ, Walker JC, Newland HS. Four-year review of open eye injuries at the Royal Adelaide Hospital. Clin Exp Ophthalmol. 2002 Feb;30(1):15-8. doi: 10.1046/j.1442-9071.2002.00484.x. PubMed 11885788 ↗
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  • Yuksel H, Turkcu FM, Ahin M, Cinar Y, Cingu AK, Ozkurt Z, Bez Y, Caca H. Vision-related quality of life in patients after ocular penetrating injuries. Arq Bras Oftalmol. 2014 Apr;77(2):95-8. doi: 10.5935/0004-2749.20140024. PubMed 25076473 ↗
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  • Schrader WF. Open globe injuries: epidemiological study of two eye clinics in Germany, 1981-1999. Croat Med J. 2004 Jun;45(3):268-74. PubMed 15185415 ↗
  • Rofail M, Lee GA, O'Rourke P. Quality of life after open-globe injury. Ophthalmology. 2006 Jun;113(6):1057.e1-3. doi: 10.1016/j.ophtha.2006.02.042. No abstract available. PubMed 16751044 ↗
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  • Collins SM, Karasek RA, Costas K. Job strain and autonomic indices of cardiovascular disease risk. Am J Ind Med. 2005 Sep;48(3):182-93. doi: 10.1002/ajim.20204. PubMed 16094616 ↗
  • de Jonge J, Bosma H, Peter R, Siegrist J. Job strain, effort-reward imbalance and employee well-being: a large-scale cross-sectional study. Soc Sci Med. 2000 May;50(9):1317-27. doi: 10.1016/s0277-9536(99)00388-3. PubMed 10728851 ↗
  • Evans S, Huxley P, Gately C, Webber M, Mears A, Pajak S, Medina J, Kendall T, Katona C. Mental health, burnout and job satisfaction among mental health social workers in England and Wales. Br J Psychiatry. 2006 Jan;188:75-80. doi: 10.1192/bjp.188.1.75. PubMed 16388074 ↗
  • Goldstone AR, Callaghan CJ, Mackay J, Charman S, Nashef SA. Should surgeons take a break after an intraoperative death? Attitude survey and outcome evaluation. BMJ. 2004 Feb 14;328(7436):379. doi: 10.1136/bmj.37985.371343.EE. Epub 2004 Jan 20. PubMed 14734519 ↗
  • Karasek R, Baker D, Marxer F, Ahlbom A, Theorell T. Job decision latitude, job demands, and cardiovascular disease: a prospective study of Swedish men. Am J Public Health. 1981 Jul;71(7):694-705. doi: 10.2105/ajph.71.7.694. PubMed 7246835 ↗
  • Karasek R, Brisson C, Kawakami N, Houtman I, Bongers P, Amick B. The Job Content Questionnaire (JCQ): an instrument for internationally comparative assessments of psychosocial job characteristics. J Occup Health Psychol. 1998 Oct;3(4):322-55. doi: 10.1037//1076-8998.3.4.322. PubMed 9805280 ↗
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  • Schnall PL, Pieper C, Schwartz JE, Karasek RA, Schlussel Y, Devereux RB, Ganau A, Alderman M, Warren K, Pickering TG. The relationship between 'job strain,' workplace diastolic blood pressure, and left ventricular mass index. Results of a case-control study. JAMA. 1990 Apr 11;263(14):1929-35. Erratum In: JAMA 1992 Mar 4;267(9):1209. PubMed 2138234 ↗
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  • Hilton MF, Whiteford HA. Associations between psychological distress, workplace accidents, workplace failures and workplace successes. Int Arch Occup Environ Health. 2010 Dec;83(8):923-33. doi: 10.1007/s00420-010-0555-x. Epub 2010 Jul 2. PubMed 20596722 ↗
  • Siegrist J, Klein D, Voigt KH. Linking sociological with physiological data: the model of effort-reward imbalance at work. Acta Physiol Scand Suppl. 1997;640:112-6. PubMed 9401620 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03706560
Lead sponsor
University Hospital, Clermont-Ferrand
Responsible party
Sponsor
First posted
Oct 16, 2018
Start date
Jun 18, 2018
Primary completion
Dec 31, 2022 (estimated)
Completion
Feb 28, 2023 (estimated)
Last update
Oct 25, 2018

Study contacts

Lise LACLAUTRE
Contact
drci@chu-clermontferrand.fr
04 73 75 49 63
Frédéric DUTHEIL, MD,PhD
principal investigator · University Hospital, Clermont-Ferrand

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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