Influence of Keratoconus on Stress at Work (KERATOSTRESS)

October 18, 2023 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63000
        • CHU - Gabriel Montpied

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stress at work
Time Frame: day 0
measured by Job Content questionnaire of Karasek
day 0

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
psychological consequences
Time Frame: Day 0
measured by HAD scale
Day 0
Stoppage of work
Time Frame: Day 0
professional consequences of stoppage of work : reclassifications
Day 0
Duration of stoppage of work
Time Frame: Day 0
professional consequences of duration of stoppage of work : reclassifications
Day 0
characteristics of the patient
Time Frame: day 0
sex, age, occupation
day 0
Measure of visual acuity.
Time Frame: Day 0
Consequence of keratoconous on visual acuity
Day 0
Mode of correction.
Time Frame: Day 0
visual consequences of keratoconus on mode of correction
Day 0
staging of keratoconous
Time Frame: Day 0
visual consequences of keratoconus on keratoconous stage
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Investigators

  • Principal Investigator: Frédéric Dutheil, University Hospital, Clermont-Ferrand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2021

Primary Completion (Actual)

May 5, 2023

Study Completion (Actual)

May 5, 2023

Study Registration Dates

First Submitted

March 3, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 9, 2021

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RNI 2018 DUTHEIL 2
  • 2018-A02527-48 (Other Identifier: 2018-A02527-48)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Keratoconus in One or Two Eyes for Case

  • University of Sao Paulo
    Santander
    Terminated
    Ear Acupuncture Effectiveness In Reducing The Signs And Symptoms Of Stress And Anxiety (EAEIRTSOSAA)
    Inclusion Criteria: | Voluntary Participation in the Study With Available Time for Submission to the Sessions, Which Occur Over Two Months. | Have a Score of Stress Medium, High or Very High in the LSS Questionnaire, Completion of the STAI and General Form. | Exclusion Criteria: | Pregnant...
  • Hospital de Sao Sebastiao
    Instituto de Ciências Biomédicas Abel Salazar; The Novo Nordisk Foundation...
    Recruiting
    Surgical Innovation for Diabetes Treatment 2 (SURIDIAB2)
    Enteroendocrine Physiological Changes in Superobese Patients Submitted to Two Different Bariatric Procedures | Determine Whether BPD With DS or SADI-S as Primary or Revisional Surgery is Superior Than the Other as First Choice for the Superobese | Determine Whether or Not Revision...
    Portugal
  • University Of Perugia
    Unknown
    ONE WEEK VERSUS FOUR WEEK HEPARIN PROPHYLAXIS AFTER LAPAROSCOPIC SURGERY FOR COLORECTAL CANCER. (PRO-LAPS I)
    The Primary Study Objective is to Assess the Efficacy and | Safety of Extended 4-week Heparin Prophylaxis Compared to | Prophylaxis Given for 8±2 Days After Planned Laparoscopic | Surgery for Colorectal Cancer. | The Clinical Benefit Will be Evaluated as the Difference in | the Incidence of... and other conditions
    Italy

Clinical Trials on auto-questionnaire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Belarus

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe