Clinical trial NCT05323526: Validation of the Catquest-9SF Questionnaire in Greek Language
Official title: Validation of the Catquest-9SF Questionnaire in Greek Language
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Catquest-9SF
Keywords: cataract
catquest
validation
questionnaire
Rasch Analysis
Lead sponsor: Democritus University of Thrace
Sponsor class: OTHER
First posted: 2022-04-12
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients diagnosed with cataract who will undergo cataract surgery.

Brief summary: Primary objective of this study is the validation of the Catquest-9SF questionnaire in the Greek population.

Detailed description: The present study aims to validate the Catquest-9SF questionnaire in the Greek population. The Catquest-9SF is a questionnaire for assessing the quality of vision of patients with cataract. It consists of 9 questions, two of which concern the subjective assessment of the patient's vision and the other seven the patient's ability to perform various daily activities.

The Catquest-9SF questionnaire were translated into the Greek language by a translation team consisting of five members: one translation coordinator, two professional native English-speaking translators, one professional native Greek-speaking translator and one native Greek ophthalmologist fluent in English.

Patients participating in the study are asked to complete a questionnaire in Greek before and after cataract surgery. Upon completion of the data collection, data are processed and analyzed through Rasch analysis to determine whether the questionnaire can be used in clinical practice in this translated version.

The following clinical parameters are evaluated: age, gender, preoperative and postoperative monocular distance uncorrected visual acuity (UVA), distance best spectacle-corrected visual acuity (BSCVA) of the eye for cataract surgery, binocular distance UVA and BSCVA, refraction, spherical equivalent (SE), and intraocular pressure.

Eligibility criteria: Inclusion Criteria:

* Patients with unilateral or bilateral senile cataract with stage 2 nuclear opalescence according to the Lens Opacities Classification System III (LOCS-3) grading scale, and no severe cognitive impairment during their preoperative examination.

Exclusion Criteria:

* Patients with difficulty with the Greek language or dementia, Alzheimer's disease, severe stroke with mental disorder and conditions with the onset of mental retardation.

Primary outcomes:
measure: Rasch Analysis: Response category ordering
timeFrame: 3 months
measure: Rasch Analysis: Item fit statistics [infit and outfit mean square (MNSQ)]
timeFrame: 3 months
measure: Rasch Analysis: Principal components analysis (PCA)
timeFrame: 3 months
measure: Rasch Analysis: Person Separation Index (PSI)
timeFrame: 3 months
measure: Rasch Analysis: Person Reliability (PR)
timeFrame: 3 months
measure: Rasch Analysis: Differential Item Functioning (DIF)
timeFrame: 3 months
measure: Rasch Analysis: Τargeting
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandroupolis
country: Greece
facility: Department of Ophthalmology, University Hospital of Alexandroupolis
state: Evros
city: Kalamata
country: Greece
facility: General Hospital of Kalamata
state: Messinia
Study officials:
affiliation: Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
name: Georgios Labiris, MD, PhD
role: STUDY_CHAIR
References: