MyodesopiaNCT04943471
Personality Traits in Patients Seeking a Consultation for Treatment for Floaters
An observational study of Myodesopia, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
This study aims to assess if certain personality traits are move prevalent in patients seeking consultation for treatment of floaters, despite good visual acuity and no other ocular pathology compared to the normal population. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Myodesopia
- What is being tested?
- Big Five Questionnaire, Patient health questionnaire-9 and generalised anxiety disorder -7 questionnaire
- How many people
- 153 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Dec 2021to 3 Aug 2022
- 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 aged 18 or over who have contacted an Ophthlamologist for a consultation for treatment for myodesopia which has lasted more than 3 months
Who may be able to join
- • Patients aged 18 or over who have contacted an Ophthalmologist for a consultation for treatment for myodesopsia which has lasted for over 3 months
Who cannot join
- • Patients with co-existing ocular pathology e.g. uveitis, glaucoma, pathological myopia (refractive error > -6D)
- Patients with cognitive impairment or learning difficulties that would affect their ability to access and complete the questionnaire
- Patients with known personality disorders
- Patients must be able to read, speak and understand English so they can comprehend the patient information sheet and questionnaire
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Manchester University NHS Foundation Trust
Manchester, M13 9WL
About this study
Official title: Assessment of Personality Traits in Patients With Symptomatic Floaters Seeking Consultation for Its Treatment
This study aims to assess if certain personality traits are move prevalent in patients seeking consultation for treatment of floaters, despite good visual acuity and no other ocular pathology compared to the normal population.
Read the detailed description
This study aims to assess if certain personality traits are move prevalent in patients seeking consultation for treatment of floaters, despite good visual acuity and no other ocular pathology compared to the normal population. A questionnaire utilising a validated personality trait assessment the 'Big Five Inventory' will collect information patients who have sought a consultation (or already had treatment in the form of vitrectomy) for floaters. We will also assess whether these patients are suffering from any degree of depression or anxiety using two validated screening questionnaires; the patient health questionnaire-9 to screen for depression, and the generalised anxiety disorder - 7 questionnaire to screen for anxiety. Identifying personality traits of patients who seek further help and potential therapeutic intervention, could help clinicians identify the individual factors that lead to this debilitating condition in some patients, despite having a healthy eye and may help determine future non-surgical minimally-interventional therapeutic approaches in the future
- Conditions
- Myodesopia
- Being tested
- Big Five Questionnaire, Patient health questionnaire-9 and generalised anxiety disorder -7 questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Big Five Questionnaire, Patient health questionnaire-9 and generalised anxiety disorder -7 questionnaireOther
Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| All patients will be given a questionnaire | All patients will be given the Big Five Questionnaire Receives: Other: Big Five Questionnaire, Patient health questionnaire-9 and generalised anxiety disorder -7 questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of neuroticism in patient group compared to an established normative database
Patients will complete a big five inventory questionnaire. This assesses five personality traits using a likert scale. There are 44 statements. The degree to which patients agree with each statement calculates their score, with certain statements being reversed scored. Patients indicate agreement by stating they either disagree strongly, disagree a little, neither agree nor disagree, agree a little or strongly agree. In items scored normally disagree strongly will give the minimum score of 1, with strongly agreeing giving a score of 5. For items which are reversed scored disagree strongly will give a score of 5, and strongly agreeing will give a score of 1.
Measured: 6 months
Secondary outcomes (2)
Difference in degree of other 4 personality measures in the big five inventory and normative database
The difference in extraversion, agreeableness, conscientiousness, openness in the recruited patient database and normative database will be analysed
Measured: 6 months
Difference in degree of anxiety and depression between normative database and recruited patients
The patient health questionnaire -9 and generalised anxiety disorder questionnaire will be given to patients. These are commonly used tools to screen/assess depression and anxiety. With both questionnaires the higher the score, the greater the degree of anxiety or depression. The frequency of depression and anxiety within the patient group will be assessed and multivariate regression analysis will be done to see if there is an association with any of the personality traits.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2021
- Study start15 Dec 2021
- Primary completion3 Aug 2022
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyodesopiaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04943471
- Sponsor's protocol ID
- 301344
- Status last verified
- Aug 2022
- First submitted
- 21 Jun 2021
- Last updated
- 31 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Personality Traits in Patients With Symptomatic Floaters Seeking Consultation for Its Treatment
- ClinicalTrials.gov ID
- NCT04943471
- Acronym / sponsor ID
- 301344
- Conditions
- Myodesopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 15 Dec 2021 (actual)
- Primary completion
- 3 Aug 2022 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 29 Jun 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.
This study aims to assess if certain personality traits are move prevalent in patients seeking consultation for treatment of floaters, despite good visual acuity and no other ocular pathology compared to the normal population.
Detailed description
This study aims to assess if certain personality traits are move prevalent in patients seeking consultation for treatment of floaters, despite good visual acuity and no other ocular pathology compared to the normal population. A questionnaire utilising a validated personality trait assessment the 'Big Five Inventory' will collect information patients who have sought a consultation (or already had treatment in the form of vitrectomy) for floaters. We will also assess whether these patients are suffering from any degree of depression or anxiety using two validated screening questionnaires; the patient health questionnaire-9 to screen for depression, and the generalised anxiety disorder - 7 questionnaire to screen for anxiety. Identifying personality traits of patients who seek further help and potential therapeutic intervention, could help clinicians identify the individual factors that lead to this debilitating condition in some patients, despite having a healthy eye and may help determine future non-surgical minimally-interventional therapeutic approaches in the future
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients will be given a questionnaire | – | Other: Big Five Questionnaire, Patient health questionnaire-9 and generalised anxiety disorder -7 questionnaireAll patients will be given the Big Five Questionnaire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged 18 or over who have contacted an Ophthlamologist for a consultation for treatment for myodesopia which has lasted more than 3 months
Key inclusion criteria (1 listed)
- • Patients aged 18 or over who have contacted an Ophthalmologist for a consultation for treatment for myodesopsia which has lasted for over 3 months
Key exclusion criteria (4 listed)
- • Patients with co-existing ocular pathology e.g. uveitis, glaucoma, pathological myopia (refractive error > -6D)
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 |
|---|---|---|
| Big Five Questionnaire, Patient health questionnaire-9 and generalised anxiety disorder -7 questionnaireQuestionnaire | Other | All patients will be given a questionnaire |
Primary outcome
Degree of neuroticism in patient group compared to an established normative database
Time frame: 6 months
Patients will complete a big five inventory questionnaire. This assesses five personality traits using a likert scale. There are 44 statements. The degree to which patients agree with each statement calculates their score, with certain statements being reversed scored. Patients indicate agreement by stating they either disagree strongly, disagree a little, neither agree nor disagree, agree a little or strongly agree. In items scored normally disagree strongly will give the minimum score of 1, with strongly agreeing giving a score of 5. For items which are reversed scored disagree strongly will give a score of 5, and strongly agreeing will give a score of 1.
2 secondary outcomes
Difference in degree of other 4 personality measures in the big five inventory and normative database
Time frame: 6 months
Difference in degree of anxiety and depression between normative database and recruited patients
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2022.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
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 Myodesopia, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 31 Aug 2022. 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 United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Degree of neuroticism in patient group compared to an established normative database (time frame: 6 months). 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 31 Aug 2022.