Influence of Keratoconus on Stress at Work

Good Visual Acuity for Control Clinical Trial

— KERATOSTRESS  

Official title:

Influence of Keratoconus on Stress at Work

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04789707
• Other study ID #: RNI 2018 DUTHEIL 2
• Secondary ID: 2018-A02527-48
• Status: Terminated
• Start date: May 4, 2021
• Est. completion date: May 5, 2023

Study information

• Verified date: October 2023
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: May 5, 2023
• Est. primary completion date: May 5, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Good Visual Acuity for Control
• Keratoconus
• Keratoconus in One or Two Eyes for Case

Intervention

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

Locations

Country	Name	City	State
France	CHU - Gabriel Montpied	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	stress at work	measured by Job Content questionnaire of Karasek	day 0
Secondary	psychological consequences	measured by HAD scale	Day 0
Secondary	Stoppage of work	professional consequences of stoppage of work : reclassifications	Day 0
Secondary	Duration of stoppage of work	professional consequences of duration of stoppage of work : reclassifications	Day 0
Secondary	characteristics of the patient	sex, age, occupation	day 0
Secondary	Measure of visual acuity.	Consequence of keratoconous on visual acuity	Day 0
Secondary	Mode of correction.	visual consequences of keratoconus on mode of correction	Day 0
Secondary	staging of keratoconous	visual consequences of keratoconus on keratoconous stage	Day 0