Italian translation and validation of the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)

Fabrizio Zeri; Silvia Tavazzi; Shehzad A Naroo; Alberto Recchioni; Francesco Menduni; Erika Ponzini; Robin Chalmers; Alfredo Desiato

doi:10.1016/j.clae.2023.101842

Italian translation and validation of the Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8)

Cont Lens Anterior Eye. 2023 Jun;46(3):101842. doi: 10.1016/j.clae.2023.101842. Epub 2023 Apr 4.

Authors

Fabrizio Zeri¹, Silvia Tavazzi², Shehzad A Naroo³, Alberto Recchioni⁴, Francesco Menduni³, Erika Ponzini⁵, Robin Chalmers⁶, Alfredo Desiato³

Affiliations

¹ Department of Materials Science, University of Milano-Bicocca, Milan, Italy; Research Centre in Optics and Optometry (COMiB), University of Milano-Bicocca, Milan, Italy; College of Health and Life Sciences, Aston University, Birmingham, UK.
² Department of Materials Science, University of Milano-Bicocca, Milan, Italy; Research Centre in Optics and Optometry (COMiB), University of Milano-Bicocca, Milan, Italy. Electronic address: silvia.tavazzi@unimib.it.
³ College of Health and Life Sciences, Aston University, Birmingham, UK.
⁴ College of Health and Life Sciences, Aston University, Birmingham, UK; Academic Unit of Ophthalmology, Institute of Inflammation and Ageing, University of Birmingham, UK; Birmingham and Midland Eye Centre, Birmingham, UK.
⁵ Department of Materials Science, University of Milano-Bicocca, Milan, Italy; Research Centre in Optics and Optometry (COMiB), University of Milano-Bicocca, Milan, Italy.
⁶ Clinical Trial Consultant, Atlanta, GA, USA.

PMID: 37024414
DOI: 10.1016/j.clae.2023.101842

Abstract

Purpose: To translate and validate an Italian version of the CLDEQ-8 (CLDEQ-8_IT).

Methods: The study was carried out in two phases. In the first phase, a cross-cultural adaptation of CLDEQ-8 to Italian was performed by forward and backward translation in sequence. In the second phase, a multi-centre study was conducted for the validation of the questionnaire. Validity CLDEQ-8_IT was evaluated against three gestalt questions: overall opinion of soft contact lenses (CLs), global self-assessments of eye sensitivity and eye dryness. Reliability was evaluated by test-retest assessment in a subgroup of subjects. Finally, the psychometric properties of CLDEQ-8_IT were explored by Rasch analysis.

Results: Two hundred and forty soft CL wearers, fluent Italian speakers (73 males and 167 females), between 18 and 70 years of age were enrolled. A significant correlation was found between CLDEQ-8_IT and each of the three Gestalt questions. The cutoff score of 12 points demonstrated the best balance between sensitivity and specificity in differentiating wearers grading their CLs as "Excellent/Very good" from those reporting their overall opinion as "Good/Fair/Poor". The Intraclass Correlation Coefficient between test and retest was 0.88 (95% CI: 0.81-0.92). Finally, infit and outfit statistics using Rasch analysis for the 8 items were in a good range, however Principal Components Analysis revealed a certain degree of multi-dimensionality of the instrument. Also, item 8 analysis could be computed after merging the last two response categories.

Conclusion: The CLDEQ-8_IT showed very good validity and reliability in measuring symptoms of CL wearers, comparable to the original English language version. A cut-off of 12 was confirmed as yielding the best balance between sensitivity and specificity in detecting CL wearers who could benefit from clinical management of their CL-related symptoms. Collapsing of the response options 5 and 6 in the last item of questionnaire could optimise its functioning.

Keywords: CLDEQ-8_IT; Contact lens discomfort; Questionnaire; Symptoms.

Publication types

Multicenter Study

MeSH terms

Contact Lenses, Hydrophilic*
Dry Eye Syndromes* / diagnosis
Dry Eye Syndromes* / etiology
Female
Humans
Language
Male
Reproducibility of Results
Surveys and Questionnaires