Impact of Personality on Satisfaction Following Presbyopic Correction.

Sponsor

Democritus University of Thrace (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05191329

Collaborator

(none)

120

Enrollment

Location

6.9

Anticipated Duration (Months)

17.5

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Personality Patient Satisfaction Presbyopia	Diagnostic Test: TPQue Greek version, NEI-VFQ-25 Greek version

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

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Impact of Personality Type, Social Roles and Working Mandates οn Visual Capacity and Satisfaction of Patients That Underwent Pseudophakic Presbyopic Correction.

Actual Study Start Date :

Aug 28, 2021

Anticipated Primary Completion Date :

Jan 30, 2022

Anticipated Study Completion Date :

Mar 25, 2022

Arms and Interventions

Arm	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	Diagnostic Test: TPQue Greek version, NEI-VFQ-25 Greek version 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.

Arm

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

Diagnostic Test: TPQue Greek version, NEI-VFQ-25 Greek version

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.

Outcome Measures

Primary Outcome Measures

TPQue assessment [6 months]
Participants' personality traits will be evaluated by the examiner using the Greek version of the TPQue questionnaire.
NEI-VFQ-25 assessment [6 months]
Participants' vision oriented quality of life will be assessed using the Greek version of the NEI-VFQ-25

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Ophthalmology, University Hospital of Alexandroupolis	Alexandroupolis	Evros	Greece	68100

Sponsors and Collaborators

Democritus University of Thrace

Investigators

Study Chair: Georgios Labiris, MD,PhD, Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Georgios Labiris, Associate Professor, Democritus University of Thrace

ClinicalTrials.gov Identifier:

NCT05191329

Other Study ID Numbers:

844/18-09-2018

First Posted:

Jan 13, 2022

Last Update Posted:

Jan 13, 2022

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Georgios Labiris, Associate Professor, Democritus University of Thrace

multifocal presbyopic correction

personality traits

vision oriented quality of life

Additional relevant MeSH terms:

Presbyopia

Personality Disorders

Study Results

No Results Posted as of Jan 13, 2022