NCT03706560

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2018

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

July 5, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

October 16, 2018

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2023

Completed
Last Updated

October 25, 2018

Status Verified

October 1, 2018

Enrollment Period

4.5 years

First QC Date

July 5, 2018

Last Update Submit

October 23, 2018

Conditions

Keywords

workerseye injurieswork abilities

Outcome Measures

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.

    at 6 months

Secondary Outcomes (18)

  • Far final visual acuity

    at 6 months

  • Mecanism of ocular trauma

    at least 6 months after their hospitalization for ocular trauma

  • Initial ocular lesions

    at day 1

  • Final ocular sequelae

    at 6 month

  • Proportion of work-related ocular trauma

    at 6 month

  • +13 more secondary outcomes

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

RECRUITING

Related Publications (39)

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MeSH Terms

Conditions

Eye InjuriesOccupational Stress

Condition Hierarchy (Ancestors)

Facial InjuriesCraniocerebral TraumaTrauma, Nervous SystemNervous System DiseasesEye DiseasesWounds and InjuriesOccupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • FrĂ©dĂ©ric DUTHEIL, MD,PhD

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2018

First Posted

October 16, 2018

Study Start

June 18, 2018

Primary Completion

December 31, 2022

Study Completion

February 28, 2023

Last Updated

October 25, 2018

Record last verified: 2018-10

Locations