Sponsor study identifier
observational
100
1 country
2
Study Start
February 15, 2020
Actual (reported)Primary Completion
April 15, 2021
Actual (reported)Study Completion
December 15, 2021
Actual (reported)Primary objective of this study is the validation of the Catquest-9SF questionnaire in the Greek population.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 15, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 15, 2020
Actual (reported)April 15, 2021
Actual (reported)December 15, 2021
Actual (reported)April 5, 2022
Actual (reported)April 12, 2022
Actual (reported)Rasch Analysis: Response category ordering
Response category ordering is evaluated graphically with category probability curves by observing whether the four response categories - omitting 'Cannot decide' as missing - (three category thresholds) are utilized in ascending order.
3 months
Rasch Analysis: Item fit statistics [infit and outfit mean square (MNSQ)]
Item fit statistics are used for the evaluation of the unidimensionality. When data fit well, the items should contribute to a single construct (visual disability) indicating the unidimensionality of the questionnaire (or the subscale). Both infit and outfit mean squares have an expected value of 1.0, with an ideal range of 0.7 to 1.3, and an acceptable range of 0.5 to 1.5) A value \< 0.7 indicates too little variance and easily predicted questions, while \> 1.3 indicates too much variance.
3 months
Rasch Analysis: Principal components analysis (PCA)
PCA is used for the evaluation of the unidimensionality. Two criteria are used; the PCA assessment is performed by comparing the amount of variance explained empirically and by the model, and the amount of variance explained by the first contrast (additional dimension). For unidimensionality, the unexplained variance in the first contrast of the residuals should be \< 2.0 eigenvalue units, and ≥ 60% of variance should ideally be explained by the measure, while a percentage of ≥ 50% is acceptable.
100 patients who will undergo cataract surgery
Patients complete the questionnaire preoperatively and postoperatively.
The following clinical parameters are evaluated: age, gender, ocular and systemic comorbidities, educational level, 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.
Patients diagnosed with cataract who will undergo cataract surgery.
Department of Ophthalmology, University Hospital of Alexandroupolis
Alexandroupoli, Evros, 68100, Greece
General Hospital of Kalamata
Kalamata, Messinia, 24100, Greece
Nanos P, Kouteliari V, Panagiotopoulou EK, Papadopoulos N, Ntonti P, Labiris G. Catquest-9SF questionnaire: Validation in a Greek-speaking population using Rasch analysis. PLoS One. 2022 Dec 7;17(12):e0278683. doi: 10.1371/journal.pone.0278683. eCollection 2022.
Georgios Labiris, MD, PhD
Department of Ophthalmology, University Hospital of Alexandroupolis, Alexandroupolis, Greece
100 participants (actual enrollment reported by the registry).
First Submitted
April 5, 2022
First Posted
April 12, 2022
Study Start
February 15, 2020
Actual (reported)Aqualase Versus Torsional ip. A Study on Endothelial Cells, Corneal Edema and Corneal Sensitivity
3 months
Rasch Analysis: Person Separation Index (PSI)
PSI contributes to the assessment of the measurement precision of the Greek Catquest-9SF. PSI implies the questionnaire's ability to differentiate along its scale. The greater the value of person separation, the greater the questionnaire precision (acceptable person separation \> 3.0).
3 months
Rasch Analysis: Person Reliability (PR)
PR contributes to the assessment of the measurement precision of the Greek Catquest-9SF. PR (ranging from 0 to 1) should be \> 0.9 to be considered adequate, indicating a high ability to distinguish between the strata of person ability.
3 months
Rasch Analysis: Differential Item Functioning (DIF)
DIF indicates the differences between different subgroups of patients, since the questionnaire item calibration should be comparable across different patient groups. DIF occurs if patients from different subgroups with the same underlying true ability have an unequal probability of giving of a response to an item. DIF is assessed by evaluating age, gender, existence of ocular comorbidities, first vs second eye cataract surgery and binocular distance BSCVA. DIF of \>1.0 logits is significant, DIF with values between 0.5 and 1.0 is minimal, and DIF \<0.5 logits is considered absent.
3 months
Rasch Analysis: Τargeting
Τargeting of the questions to the patient sample, which indicates how well the items' difficulties match the person ability, is assessed to establish if the questions are appropriate for patients before and following cataract surgery. This can be assessed graphically by observing the spread along the person-item map and by the difference between the item and the person mean values. A well-targeted instrument requires the ability of the patients and the difficulty of the questions to be centered on the same mean (targeting of 0). In general, a mean difference in magnitude of ≥1 logit indicates significant mistargeting, while a difference of \<1.0 logit indicates good targeting, with targeting of 0 being ideal. A positive value indicates that the items are too difficult relative to person's ability, while a negative value indicates that the items are too easy. A person-item map also visualizes the item hierarchy of difficulty, ranging from a minimum to maximum difficulty of performance.
3 months
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Contact the study team to confirm eligibility.
Primary Completion
April 15, 2021
Actual (reported)Study Completion
December 15, 2021
Actual (reported)Last Updated
April 19, 2022
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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