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Influence of Keratoconus on Stress at Work (KERATOSTRESS)

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ClinicalTrials.gov Identifier: NCT04789707
Recruitment Status : Recruiting
First Posted : March 9, 2021
Last Update Posted : May 6, 2021
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Study Description
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Brief Summary:

Keratoconus is a progressive disorder in which central and paracentral corneal stromal thinning occurs.

No studies evaluated the influence of keratoconus on stress at work, nor the influence of treatments of keratoconus on stress at work, including Quality of Life at work and on perception of work. Moreover, it has been shown that some pathologies had greater influence in some occupations, also depending on other characteristics of individuals such as age, sex or socio professional groups.

Therefore, we hypothesized that keratoconus 1) will influence stress at work including QoL at work and perception of work, 2) will have a greater influence in some occupations and depending on age, sex, or stage of keratoconus, 3) will induce stoppage of work and occupational reclassifications.


Condition or disease Intervention/treatment
Keratoconus in One or Two Eyes for Case Good Visual Acuity for Control Behavioral: auto-questionnaire

Detailed Description:

This is a descriptive, prospective, observational, monocentral study. For each patient with keratoconus and patient control, use of the auto questionnaire to carry out the study. we only assessed data from usual routine practice.

Stress at work is measured by Job Content Questionnaire of Karasek issued during consultations.

Study all workers the influence of keratoconus and its stage on:

  • consequences of keratoconus in function of visual acuity, mode of correction and staging of the keratoconus.
  • Psychological consequences: Quality of life at work, Perception of work (Karasek questionnaire), anxiety and depression (HAD scale)
  • Professional consequences: stoppage of work and duration and occupational reclassifications
  • Characteristics of the patient: age, sex, occupation.

Measures to reduce or avoid bias:

  • Standardized, anonymous auto questionnaire
  • A large workforce: high rate of participation is expected
  • Inclusion of control group.
Study Design
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Study Type : Observational
Estimated Enrollment : 660 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Influence of Keratoconus on Stress at Work
Actual Study Start Date : May 4, 2021
Estimated Primary Completion Date : March 2023
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
KERATOCONUS group

All workers with keratoconus all stages followed at the service of ophthalmology in CHU Gabriel Montpied, Clermont-Ferrand, Auvergne.

The investigators only assessed data from usual routine practice. Patients answer the auto questionnaire in last minutes of consultation.

 Behavioral: auto-questionnaire
Patients answer the auto questionnaire in last minutes of consultation.
CONTROL group

workers with good visual acuity consulting in ophthalmology service of Clermont-Ferrand.

The investigators only assessed data from usual routine practice. Patients answer the auto questionnaire in last minutes of consultation.

 Behavioral: auto-questionnaire
Patients answer the auto questionnaire in last minutes of consultation.


Outcome Measures
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Primary Outcome Measures :
  1. stress at work [ Time Frame: day 0 ]
    measured by Job Content questionnaire of Karasek


Secondary Outcome Measures :
  1. psychological consequences [ Time Frame: Day 0 ]
    measured by HAD scale

  2. Stoppage of work [ Time Frame: Day 0 ]
    professional consequences of stoppage of work : reclassifications

  3. Duration of stoppage of work [ Time Frame: Day 0 ]
    professional consequences of duration of stoppage of work : reclassifications

  4. characteristics of the patient [ Time Frame: day 0 ]
    sex, age, occupation

  5. Measure of visual acuity. [ Time Frame: Day 0 ]
    Consequence of keratoconous on visual acuity

  6. Mode of correction. [ Time Frame: Day 0 ]
    visual consequences of keratoconus on mode of correction

  7. staging of keratoconous [ Time Frame: Day 0 ]
    visual consequences of keratoconus on keratoconous stage


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
patients with keratoconus patients constituting a representative control group of workers consulting in ophthalmology service of Clermont-Ferrand.
Criteria

Inclusion Criteria:

  • patients with keratoconus all stages followed at the CHU Gabriel Montpied,
  • patients constituting a representative control group of workers consulting in ophthalmology service of Clermont-Ferrand.

Exclusion Criteria:

  • an other ophtalmological disease alters visual acuity.
  • minors subjects
  • inability to provide informed consent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04789707


Contacts
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Contact: Lise Laclautre 334.73.754.963 promo_interne_drci@chu-clermontferrand.fr

Locations
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France
CHU - Gabriel Montpied Recruiting
Clermont-Ferrand, France, 63000
Principal Investigator: Frédéric DUTHEIL         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
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Principal Investigator: Frédéric DUTHEIL University Hospital, Clermont-Ferrand
More Information
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Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT04789707    
Other Study ID Numbers: RNI 2018 DUTHEIL 2
2018-A02527-48 ( Other Identifier: 2018-A02527-48 )
First Posted: March 9, 2021    Key Record Dates
Last Update Posted: May 6, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Clermont-Ferrand:
keratoconus
Karasek
stress at work
Additional relevant MeSH terms:
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Keratoconus
Corneal Diseases
Eye Diseases