- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05191329
Impact of Personality on Satisfaction Following Presbyopic Correction
January 2, 2023 updated by: Georgios Labiris, Democritus University of Thrace
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
120
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
-
-
Evros
-
Alexandroupolis, Evros, Greece, 68100
- Department of Ophthalmology, University Hospital of Alexandroupolis
-
-
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
40 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
participants with presbyopia, either surgically or non surgically corrected, aged 40 to 85 years
Description
Inclusion Criteria:
- presbyopia, patients of our outpatient ophthalmology clinic, age between 40 and 85 years
Exclusion Criteria:
- inability to cooperate, former diagnosis of mental disease
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 |
|---|---|
|
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
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
6 months
|
|
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.
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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)
August 28, 2021
Primary Completion (Actual)
January 30, 2022
Study Completion (Actual)
March 25, 2022
Study Registration Dates
First Submitted
December 30, 2021
First Submitted That Met QC Criteria
December 30, 2021
First Posted (Actual)
January 13, 2022
Study Record Updates
Last Update Posted (Actual)
January 4, 2023
Last Update Submitted That Met QC Criteria
January 2, 2023
Last Verified
January 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 844/18-09-2018
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
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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