Clinical trial NCT04789707: Influence of Keratoconus on Stress at Work
Official title: Influence of Keratoconus on Stress at Work
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Keratoconus in One or Two Eyes for Case
Good Visual Acuity for Control
Keywords: keratoconus
Karasek
stress at work
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: stress at work
timeFrame: day 0
Secondary outcomes:
measure: psychological consequences
timeFrame: Day 0
measure: Stoppage of work
timeFrame: Day 0
measure: Duration of stoppage of work
timeFrame: Day 0
measure: characteristics of the patient
timeFrame: day 0
measure: Measure of visual acuity.
timeFrame: Day 0
measure: Mode of correction.
timeFrame: Day 0
measure: staging of keratoconous
timeFrame: Day 0
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU - Gabriel Montpied
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Frédéric DUTHEIL
role: PRINCIPAL_INVESTIGATOR
References: