NCT05191329

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 13, 2022

Completed
17 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 25, 2022

Completed
Last Updated

January 4, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

December 30, 2021

Last Update Submit

January 2, 2023

Conditions

Keywords

multifocal presbyopic correctionpersonality traitsvision oriented quality of life

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    6 months

Study Arms (1)

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

Interventions

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

Eligibility Criteria

Age40 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

participants with presbyopia, either surgically or non surgically corrected, aged 40 to 85 years

You may qualify if:

  • presbyopia, patients of our outpatient ophthalmology clinic, age between 40 and 85 years

You may not qualify if:

  • inability to cooperate, former diagnosis of mental disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, University Hospital of Alexandroupolis

Alexandroupoli, Evros, 68100, Greece

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Patient SatisfactionPresbyopia

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehaviorRefractive ErrorsEye Diseases

Study Officials

  • Georgios Labiris, MD,PhD

    Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 30, 2021

First Posted

January 13, 2022

Study Start

August 28, 2021

Primary Completion

January 30, 2022

Study Completion

March 25, 2022

Last Updated

January 4, 2023

Record last verified: 2023-01

Locations