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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

  • United Kingdom
      • Manchester, United Kingdom, M13 9WL
        • Manchester University NHS Foundation Trust

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
All patients will be given a questionnaire
All patients will be given the Big Five Questionnaire
Other: Big Five Questionnaire, Patient health questionnaire-9 and generalised anxiety disorder -7 questionnaire
Questionnaire

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Manchester University NHS Foundation Trust

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 15, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 3, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 3, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 21, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 21, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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