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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05191329
Other study ID # 844/18-09-2018
Secondary ID
Status Completed
Phase
First received
Last updated
Start date August 28, 2021
Est. completion date March 25, 2022

Study information

Verified date January 2023
Source Democritus University of Thrace
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 120
Est. completion date March 25, 2022
Est. primary completion date January 30, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 85 Years
Eligibility 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 Design


Intervention

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.

Locations

Country Name City State
Greece Department of Ophthalmology, University Hospital of Alexandroupolis Alexandroupolis Evros

Sponsors (1)

Lead Sponsor Collaborator
Democritus University of Thrace

Country where clinical trial is conducted

Greece, 

References & 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.j — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
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