Keratoconus in One or Two Eyes for CaseKERATOSTRESSNCT04789707
Influence of Keratoconus on Stress at Work
An observational study of Keratoconus in One or Two Eyes for Case and Good Visual Acuity for Control, run by University Hospital, Clermont-Ferrand at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Keratoconus in One or Two Eyes for Case, Good Visual Acuity for Control
- What is being tested?
- auto-questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 4 May 2021to 5 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients with keratoconus patients constituting a representative control group of workers consulting in ophthalmology service of Clermont-Ferrand.
Who may be able to join
- 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.
Who cannot join
- an other ophtalmological disease alters visual acuity.
- minors subjects
- inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- auto-questionnaire
- Keywords
- keratoconus, Karasek, stress at work
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
auto-questionnaireBehavioural
Patients answer the auto questionnaire in last minutes of consultation.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: auto-questionnaire | |
| 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. Receives: Behavioral: auto-questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
stress at work
measured by Job Content questionnaire of Karasek
Measured: day 0
Secondary outcomes (7)
psychological consequences
measured by HAD scale
Measured: Day 0
Stoppage of work
professional consequences of stoppage of work : reclassifications
Measured: Day 0
Duration of stoppage of work
professional consequences of duration of stoppage of work : reclassifications
Measured: Day 0
characteristics of the patient
sex, age, occupation
Measured: day 0
Measure of visual acuity.
Consequence of keratoconous on visual acuity
Measured: Day 0
Mode of correction.
visual consequences of keratoconus on mode of correction
Measured: Day 0
staging of keratoconous
visual consequences of keratoconus on keratoconous stage
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start4 May 2021
- Primary completion5 May 2023
- Study completion5 May 2023
Why it stopped: recruitment difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratoconus in One or Two Eyes for CaseStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Frédéric DUTHEIL, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04789707
- Sponsor's protocol ID
- RNI 2018 DUTHEIL 2
- Other IDs
- 2018-A02527-48
- Acronym
- KERATOSTRESS
- Status last verified
- Oct 2023
- First submitted
- 3 Mar 2021
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Keratoconus on Stress at Work
- ClinicalTrials.gov ID
- NCT04789707
- Acronym / sponsor ID
- KERATOSTRESS / RNI 2018 DUTHEIL 2
- Keywords
- keratoconus, Karasek, stress at work
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: recruitment difficulties
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 4 May 2021 (actual)
- Primary completion
- 5 May 2023 (actual)
- Study completion
- 5 May 2023 (actual)
- First posted
- 9 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| KERATOCONUS group | – | Behavioral: auto-questionnaireAll 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 | – | Behavioral: auto-questionnaireworkers 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients with keratoconus patients constituting a representative control group of workers consulting in ophthalmology service of Clermont-Ferrand.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- an other ophtalmological disease alters visual acuity.
- minors subjects
- inability to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| auto-questionnairePatients answer the auto questionnaire in last minutes of consultation. | Behavioural | CONTROL group, KERATOCONUS group |
Primary outcome
stress at work
Time frame: day 0
measured by Job Content questionnaire of Karasek
7 secondary outcomes
psychological consequences
Time frame: Day 0
Stoppage of work
Time frame: Day 0
Duration of stoppage of work
Time frame: Day 0
characteristics of the patient
Time frame: day 0
Measure of visual acuity.
Time frame: Day 0
Mode of correction.
Time frame: Day 0
staging of keratoconous
Time frame: Day 0
Results and safety
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frédéric DUTHEIL principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Keratoconus in One or Two Eyes for Case and Good Visual Acuity for Control, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: recruitment difficulties). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stress at work (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.