Study Stopped
recruitment difficulties
Influence of Keratoconus on Stress at Work
KERATOSTRESS
2 other identifiers
observational
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 3, 2021
CompletedFirst Posted
Study publicly available on registry
March 9, 2021
CompletedStudy Start
First participant enrolled
May 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 5, 2023
CompletedOctober 19, 2023
October 1, 2023
2 years
March 3, 2021
October 18, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
stress at work
measured by Job Content questionnaire of Karasek
day 0
Secondary Outcomes (7)
psychological consequences
Day 0
Stoppage of work
Day 0
Duration of stoppage of work
Day 0
characteristics of the patient
day 0
Measure of visual acuity.
Day 0
- +2 more secondary outcomes
Study Arms (2)
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.
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.
Interventions
Patients answer the auto questionnaire in last minutes of consultation.
Eligibility Criteria
patients with keratoconus patients constituting a representative control group of workers consulting in ophthalmology service of Clermont-Ferrand.
You may qualify if:
- 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.
You may not qualify if:
- an other ophtalmological disease alters visual acuity.
- minors subjects
- inability to provide informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU - Gabriel Montpied
Clermont-Ferrand, 63000, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Frédéric DUTHEIL
University Hospital, Clermont-Ferrand
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 3, 2021
First Posted
March 9, 2021
Study Start
May 4, 2021
Primary Completion
May 5, 2023
Study Completion
May 5, 2023
Last Updated
October 19, 2023
Record last verified: 2023-10