PersonalityNCT05191329
Impact of Personality on Satisfaction Following Presbyopic Correction
An observational study of Personality and Patient Satisfaction, run by Democritus University of Thrace at 1 site in Greece.
Trial summary
Primary objective of this study is the exploration of the impact of personality type, social roles and working mandates οn the visual capacity and satisfaction of patients that underwent pseudophakic presbyopic correction. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Personality, Patient Satisfaction, Presbyopia
- What is being tested?
- TPQue Greek version, NEI-VFQ-25 Greek version
- How many people
- 120 participants
- Where
- 1 siteGreece
- Study dates
- 28 Aug 2021to 25 Mar 2022
- How long will I take part?
- 6 Months
- 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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: participants with presbyopia, either surgically or non surgically corrected, aged 40 to 85 years
Who may be able to join
- presbyopia, patients of our outpatient ophthalmology clinic, age between 40 and 85 years
Who cannot join
- inability to cooperate, former diagnosis of mental disease
Trial locations and contacts
1 site in 1 country.
Greece1 site
Department of Ophthalmology, University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100
About this study
Official title: Impact of Personality Type, Social Roles and Working Mandates οn Visual Capacity and Satisfaction of Patients That Underwent Pseudophakic Presbyopic Correction
Primary objective of this study is the exploration of the impact of personality type, social roles and working mandates οn the visual capacity and satisfaction of patients that underwent pseudophakic presbyopic correction.
Read the detailed description
Personality type, social types and working mandates will be evaluated as a routine procedure to patients that visit the Presbyopia Service of the University Hospital of Alexandroupolis, by means of structured questionnaires. Six months following pseudophakic presbyopic correction surgery, each study participant will be evaluated for his/her visual capacity and vision-specific quality of life. Regression modeling will be attempted in order to identify the exact demographics, social roles and personality type of the patient that is most compatible to receive pseudophakic presbyopic correction.
- Conditions
- Personality, Patient Satisfaction, Presbyopia
- Being tested
- TPQue Greek version, NEI-VFQ-25 Greek version
- Keywords
- multifocal presbyopic correction, personality traits, vision oriented quality of life
- Medical subject headings
- Patient Satisfaction, Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TPQue Greek version, NEI-VFQ-25 Greek versionDiagnostic test
Study participants with non surgical presbyopic correction will be evaluated with TPQue regarding their personality traits. Visual acuity will also be assessed. Study participants with pseudophakic presbyopic correction will be evaluated with the TPQue before surgery. They will also be visual acuity evaluation and NEI-VFQ-25 assessment six months after surgery.
| Study group | Role | What they receive |
|---|---|---|
| study group | 40 patients with non surgical presbyopic correction e.g. glasses and 80 patients that underwent pseudophakic presbyopic correction with multifocal or trifocal IOLs Receives: Diagnostic Test: TPQue Greek version, NEI-VFQ-25 Greek version |
What is being measured
The primary outcome is the main question the study is designed to answer.
TPQue assessment
Participants' personality traits will be evaluated by the examiner using the Greek version of the Traits Personality (TPQue) questionnaire, with a scale from 0 to 100. 100 is the highest percentage of a certain trait.
Measured: 6 months
NEI-VFQ-25 assessment
Participants' vision oriented quality of life will be assessed using the Greek version of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25), with a scale from 0 to 100. 100 being the highest satisfaction rate.
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 posted13 Jan 2022
- Study start28 Aug 2021
- Primary completion30 Jan 2022
- Study completion25 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PersonalityStudies 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
- 120 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Democritus University of Thrace
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Labiris, Democritus University of Thrace
- Investigators
- Georgios Labiris, MD,PhD, Study chair, Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05191329
- Sponsor's protocol ID
- 844/18-09-2018
- Status last verified
- Jan 2023
- First submitted
- 30 Dec 2021
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ntonti P, Bakirtzis M, Delibasis K, Seimenis I, Tsinopoulos I, Labiris G. Impact of personality on the decision process and on satisfaction rates in pseudophakic presbyopic correction. J Cataract Refract Surg. 2022 Dec 1;48(12):1433-1439. doi: 10.1097/j.jcrs.0000000000001021.
PubMed 35862830
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Personality Type, Social Roles and Working Mandates οn Visual Capacity and Satisfaction of Patients That Underwent Pseudophakic Presbyopic Correction
- ClinicalTrials.gov ID
- NCT05191329
- Acronym / sponsor ID
- 844/18-09-2018
- Conditions
- Personality, Patient Satisfaction, Presbyopia
- Keywords
- multifocal presbyopic correction, personality traits, vision oriented quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Democritus University of ThraceUniversity, hospital or other
- Study start
- 28 Aug 2021 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 13 Jan 2022 (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.
Primary objective of this study is the exploration of the impact of personality type, social roles and working mandates οn the visual capacity and satisfaction of patients that underwent pseudophakic presbyopic correction.
Detailed description
Personality type, social types and working mandates will be evaluated as a routine procedure to patients that visit the Presbyopia Service of the University Hospital of Alexandroupolis, by means of structured questionnaires. Six months following pseudophakic presbyopic correction surgery, each study participant will be evaluated for his/her visual capacity and vision-specific quality of life. Regression modeling will be attempted in order to identify the exact demographics, social roles and personality type of the patient that is most compatible to receive pseudophakic presbyopic correction.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: TPQue Greek version, NEI-VFQ-25 Greek version40 patients with non surgical presbyopic correction e.g. glasses and 80 patients that underwent pseudophakic presbyopic correction with multifocal or trifocal IOLs |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- participants with presbyopia, either surgically or non surgically corrected, aged 40 to 85 years
Key inclusion criteria (1 listed)
- presbyopia, patients of our outpatient ophthalmology clinic, age between 40 and 85 years
Key exclusion criteria (1 listed)
- inability to cooperate, former diagnosis of mental disease
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 |
|---|---|---|
| TPQue Greek version, NEI-VFQ-25 Greek versionStudy participants with non surgical presbyopic correction will be evaluated with TPQue regarding their personality traits. Visual acuity will also be assessed. Study participants with pseudophakic presbyopic correction will be evaluated with the TPQue before surgery. They will also be visual acuity evaluation and NEI-VFQ-25 assessment six months after surgery. | Diagnostic test | study group |
Primary outcome
TPQue assessment
Time frame: 6 months
Participants' personality traits will be evaluated by the examiner using the Greek version of the Traits Personality (TPQue) questionnaire, with a scale from 0 to 100. 100 is the highest percentage of a certain trait.
NEI-VFQ-25 assessment
Time frame: 6 months
Participants' vision oriented quality of life will be assessed using the Greek version of the National Eye Institute Visual Function Questionnaire-25 (NEI VFQ-25), with a scale from 0 to 100. 100 being the highest satisfaction rate.
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 4 Jan 2023.
- Results publication: PubMed 35862830Ntonti P, Bakirtzis M, Delibasis K, Seimenis I, Tsinopoulos I, Labiris G. Impact of personality on the decision process and on satisfaction rates in pseudophakic presbyopic correction. J Cataract Refract Surg. 2022 Dec 1;48(12):1433-1439. doi: 10.1097/j.jcrs.0000000000001021.
- Individual participant dataSharing planned: Undecided
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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.
Georgios Labiris, MD,PhD study chair
Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
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 Personality and Patient Satisfaction, run by Democritus University of Thrace at 1 site in Greece.
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 1 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 4 Jan 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 Greece. 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?
TPQue assessment (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05191329, which also lists 1 linked publication.
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 4 Jan 2023.