Eye InjuriesHOT-WORKNCT03706560
Professional Consequences of Ocular Trauma Hospitalized at the Hospital Centre of Clermont-Ferrand
An observational study of Eye Injuries and Work Performance, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Eye Injuries, Work Performance, Occupational Stress
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 18 Jun 2018to 28 Feb 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
Lise LACLAUTRE, 04 73 75 49 63, drci@chu-clermontferrand.fr
Frédéric DUTHEIL, MD, PhD
About this study
Official title: Professional Consequences of Ocular Trauma Hospitalized at the University Hospital Centre of Clermont-Ferrand
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.
- Conditions
- Eye Injuries, Work Performance, Occupational Stress
- Keywords
- workers, eye injuries, work abilities
- Medical subject headings
- Eye Injuries, Occupational Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: at 6 months
Secondary outcomes (18)
Far final visual acuity
Far final visual acuity with Monoyer scale (telephone questionnaire) (in decimal).
Measured: at 6 months
Mecanism of ocular trauma
traumatism by foreign body, percussion, burn, fall, other
Measured: at least 6 months after their hospitalization for ocular trauma
Initial ocular lesions
corneal wound, scleral wound, cataract, wounds of the lid margin, of the lacrymal ducts, hyphaema, ocular hypertension, intravitreal haemorrhage, ulceration, others
Measured: at day 1
Final ocular sequelae
All ocular complications that may have an impact on the final visual fonction (qualitative scale)
Measured: at 6 month
Proportion of work-related ocular trauma
Proportion of work-related ocular trauma
Measured: at 6 month
Wear of protective eyewear during traumatism
Wear of protective eyewear during traumatism, binary scale (yes/no)
Measured: at 6 month
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)
Measured: at 6 month
Total duration of Work stoppage
days
Measured: at 6 month
Variations of time of work since the ocular trauma
hours per week
Measured: at 6 month
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
Measured: at 6 month
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
Measured: at 6 month
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)
Measured: at 6 month
Tobacco consumption
number of cigarette per day, before and after the ocular trauma
Measured: at 6 month
Alcohol consumption
before and after the ocular trauma, in number of alcohol unity per day
Measured: at 6 month
Consumption of pharmaceuticals
type of pharmaceuticals and any modification before and after the ocular trauma
Measured: at 6 month
Limitations or modifications on sport
by graduated scales (between 0 to 4) (telephone questionnaire)
Measured: at 6 month
Limitations or modifications on driving
by graduated scales (between 0 to 4) (telephone questionnaire)
Measured: at 6 month
Limitations or modifications on hobbies
by graduated scales (between 0 to 4) (telephone questionnaire)
Measured: at 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2018
- Study start18 Jun 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion28 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Eye InjuriesStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric DUTHEIL, MD,PhD, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706560
- Sponsor's protocol ID
- CHU-399
- Other IDs
- 2018-A00605-50
- Acronym
- HOT-WORK
- Status last verified
- Oct 2018
- First submitted
- 5 Jul 2018
- Last updated
- 25 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Negrel AD, Thylefors B. The global impact of eye injuries. Ophthalmic Epidemiol. 1998 Sep;5(3):143-69. doi: 10.1076/opep.5.3.143.8364.
PubMed 9805347Xiang H, Stallones L, Chen G, Smith GA. Work-related eye injuries treated in hospital emergency departments in the US. Am J Ind Med. 2005 Jul;48(1):57-62. doi: 10.1002/ajim.20179.
PubMed 15940717Pizzarello LD. Ocular trauma: time for action. Ophthalmic Epidemiol. 1998 Sep;5(3):115-6. doi: 10.1076/opep.5.3.115.8366. No abstract available.
PubMed 9805344Pinna 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 17994439Byhr E. Perforating eye injuries in a western part of Sweden. Acta Ophthalmol (Copenh). 1994 Feb;72(1):91-7. doi: 10.1111/j.1755-3768.1994.tb02744.x.
PubMed 8017204Schrader WF. [Epidemiology of open globe eye injuries: analysis of 1026 cases in 18 years]. Klin Monbl Augenheilkd. 2004 Aug;221(8):629-35. doi: 10.1055/s-2004-813254. German.
PubMed 15343446Casson 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 11885788Tielsch JM, Parver L, Shankar B. Time trends in the incidence of hospitalized ocular trauma. Arch Ophthalmol. 1989 Apr;107(4):519-23. doi: 10.1001/archopht.1989.01070010533025.
PubMed 2705918Parver LM, Dannenberg AL, Blacklow B, Fowler CJ, Brechner RJ, Tielsch JM. Characteristics and causes of penetrating eye injuries reported to the National Eye Trauma System Registry, 1985-91. Public Health Rep. 1993 Sep-Oct;108(5):625-32.
PubMed 8210260Thylefors B. Epidemiological patterns of ocular trauma. Aust N Z J Ophthalmol. 1992 May;20(2):95-8. doi: 10.1111/j.1442-9071.1992.tb00718.x.
PubMed 1389141Cillino S, Casuccio A, Di Pace F, Pillitteri F, Cillino G. A five-year retrospective study of the epidemiological characteristics and visual outcomes of patients hospitalized for ocular trauma in a Mediterranean area. BMC Ophthalmol. 2008 Apr 22;8:6. doi: 10.1186/1471-2415-8-6.
PubMed 18430231Forrest KY, Cali JM. Epidemiology of lifetime work-related eye injuries in the U.S. population associated with one or more lost days of work. Ophthalmic Epidemiol. 2009 May-Jun;16(3):156-62. doi: 10.1080/09286580902738175.
PubMed 19437310Baillif S, Paoli V. [Open-globe injuries and intraocular foreign bodies involving the posterior segment]. J Fr Ophtalmol. 2012 Feb;35(2):136-45. doi: 10.1016/j.jfo.2011.08.003. Epub 2012 Jan 9. French.
PubMed 22226765Yuksel 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 25076473Alexander DA, Kemp RV, Klein S, Forrester JV. Psychiatric sequelae and psychosocial adjustment following ocular trauma: a retrospective pilot study. Br J Ophthalmol. 2001 May;85(5):560-2. doi: 10.1136/bjo.85.5.560.
PubMed 11316717
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Professional Consequences of Ocular Trauma Hospitalized at the University Hospital Centre of Clermont-Ferrand
- ClinicalTrials.gov ID
- NCT03706560
- Acronym / sponsor ID
- HOT-WORK / CHU-399
- Conditions
- Eye Injuries, Work Performance, Occupational Stress
- Keywords
- workers, eye injuries, work abilities
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 16 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
18 secondary outcomes
Far final visual acuity
Time frame: at 6 months
Mecanism of ocular trauma
Time frame: at least 6 months after their hospitalization for ocular trauma
Initial ocular lesions
Time frame: at day 1
Final ocular sequelae
Time frame: at 6 month
Proportion of work-related ocular trauma
Time frame: at 6 month
Wear of protective eyewear during traumatism
Time frame: at 6 month
Medical opinion of professional aptitude made by the occupational physician during work resumption examination
Time frame: at 6 month
Total duration of Work stoppage
Time frame: at 6 month
Variations of time of work since the ocular trauma
Time frame: at 6 month
State of Stress and Mood at work, before and after the ocular trauma, by graduating scales (telephone questionnaire)
Time frame: at 6 month
Quality of sleep, before and after the ocular trauma by graduating scales (telephone questionnaire)
Time frame: at 6 month
Job demand, job control and social support (derived from the Karasek questionnaire)
Time frame: at 6 month
Tobacco consumption
Time frame: at 6 month
Alcohol consumption
Time frame: at 6 month
Consumption of pharmaceuticals
Time frame: at 6 month
Limitations or modifications on sport
Time frame: at 6 month
Limitations or modifications on driving
Time frame: at 6 month
Limitations or modifications on hobbies
Time frame: at 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2018.
- Background: PubMed 9805347Negrel AD, Thylefors B. The global impact of eye injuries. Ophthalmic Epidemiol. 1998 Sep;5(3):143-69. doi: 10.1076/opep.5.3.143.8364.
- Background: PubMed 15940717Xiang H, Stallones L, Chen G, Smith GA. Work-related eye injuries treated in hospital emergency departments in the US. Am J Ind Med. 2005 Jul;48(1):57-62. doi: 10.1002/ajim.20179.
- Background: PubMed 9805344Pizzarello LD. Ocular trauma: time for action. Ophthalmic Epidemiol. 1998 Sep;5(3):115-6. doi: 10.1076/opep.5.3.115.8366. No abstract available.
- Background: PubMed 17994439Pinna 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.
- Background: PubMed 8017204Byhr E. Perforating eye injuries in a western part of Sweden. Acta Ophthalmol (Copenh). 1994 Feb;72(1):91-7. doi: 10.1111/j.1755-3768.1994.tb02744.x.
- Background: PubMed 15343446Schrader WF. [Epidemiology of open globe eye injuries: analysis of 1026 cases in 18 years]. Klin Monbl Augenheilkd. 2004 Aug;221(8):629-35. doi: 10.1055/s-2004-813254. German.
- Background: PubMed 11885788Casson 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.
- Background: PubMed 2705918Tielsch JM, Parver L, Shankar B. Time trends in the incidence of hospitalized ocular trauma. Arch Ophthalmol. 1989 Apr;107(4):519-23. doi: 10.1001/archopht.1989.01070010533025.
- Background: PubMed 8210260Parver LM, Dannenberg AL, Blacklow B, Fowler CJ, Brechner RJ, Tielsch JM. Characteristics and causes of penetrating eye injuries reported to the National Eye Trauma System Registry, 1985-91. Public Health Rep. 1993 Sep-Oct;108(5):625-32.
- Background: PubMed 1389141Thylefors B. Epidemiological patterns of ocular trauma. Aust N Z J Ophthalmol. 1992 May;20(2):95-8. doi: 10.1111/j.1442-9071.1992.tb00718.x.
- Background: PubMed 18430231Cillino S, Casuccio A, Di Pace F, Pillitteri F, Cillino G. A five-year retrospective study of the epidemiological characteristics and visual outcomes of patients hospitalized for ocular trauma in a Mediterranean area. BMC Ophthalmol. 2008 Apr 22;8:6. doi: 10.1186/1471-2415-8-6.
- Background: PubMed 19437310Forrest KY, Cali JM. Epidemiology of lifetime work-related eye injuries in the U.S. population associated with one or more lost days of work. Ophthalmic Epidemiol. 2009 May-Jun;16(3):156-62. doi: 10.1080/09286580902738175.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric DUTHEIL, MD,PhD principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Injuries and Work Performance, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lise LACLAUTRE (04 73 75 49 63, drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Professionnal status of workers after the ocular trauma telephone questionnaire) (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03706560, which also lists 39 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2018.