- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04943471
Personality Traits in Patients Seeking a Consultation for Treatment for Floaters
August 30, 2022 updated by: Manchester University NHS Foundation Trust
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.
Study Overview
Status
Completed
Conditions
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 Type
Observational
Enrollment (Actual)
153
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
-
-
-
Manchester, United Kingdom, M13 9WL
- Manchester University NHS Foundation Trust
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-
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
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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
Description
Inclusion Criteria:
- • Patients aged 18 or over who have contacted an Ophthalmologist for a consultation for treatment for myodesopsia which has lasted for over 3 months
Exclusion Criteria:
• 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
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
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
All patients will be given a questionnaire
All patients will be given the Big Five Questionnaire
|
Questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Difference in degree of other 4 personality measures in the big five inventory and normative database
Time Frame: 6 months
|
The difference in extraversion, agreeableness, conscientiousness, openness in the recruited patient database and normative database will be analysed
|
6 months
|
|
Difference in degree of anxiety and depression between normative database and recruited patients
Time Frame: 6 months
|
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
December 15, 2021
Primary Completion (Actual)
August 3, 2022
Study Completion (Actual)
August 3, 2022
Study Registration Dates
First Submitted
June 21, 2021
First Submitted That Met QC Criteria
June 21, 2021
First Posted (Actual)
June 29, 2021
Study Record Updates
Last Update Posted (Actual)
August 31, 2022
Last Update Submitted That Met QC Criteria
August 30, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 301344
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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.
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