This study aims to assess the impact of myopia in childhood and its long-term complications in adulthood on health-related Quality of Life (HRQoL), providing valuable data for cost-effectiveness models. It will gather country-specific information on healthcare resource utilization, including treatment costs, access to care, and reimbursement policies. In addition, the study will examine how myopia and its treatments affect daily activities and evaluate treatment satisfaction. No data on the efficacy of myopia treatments is collected in this study, and neither is the occurrence of adverse events.
Study Type
OBSERVATIONAL
Enrollment
350
Non-Intervention study
Copenhagen University Hospital
Copenhagen, Denmark
NOT_YET_RECRUITINGUniversity Hospital Necker Enfants Malades
Paris, France
NOT_YET_RECRUITINGKlinik für Augenheilkunde (Universitätsklinikum Freiburg)
Freiburg im Breisgau, Germany
NOT_YET_RECRUITINGUniversitäts-Augenklinik Mainz
Mainz, Germany
NOT_YET_RECRUITINGMeyer Children's Hospital IRCCS
Florence, Italy
RECRUITINGPoliclinico Universitario Agostino Gemelli IRCCS
Rome, Italy
NOT_YET_RECRUITINGEstudio Oftalmologico
Madrid, Spain
NOT_YET_RECRUITINGThe San Carlos Clinic Hospital (Hospital Clinico San Carlos-HCSC)
Madrid, Spain
NOT_YET_RECRUITINGSt. Erik Eye Hospital
Solna, Sweden
NOT_YET_RECRUITINGMoorfields Eye Hospital NHS Foundation Trust
London, United Kingdom
NOT_YET_RECRUITINGGroup 1 respondents' assessment of EQ-5D-Y-3L (proxy)
Group 1 respondents are parents (or other proxy) of children and adolescents suffering from myopia. The EQ-5D-Y-3L (European Quality of Life 5 Dimensions 3 Level) proxy version is an instrument used to assess health-related quality of life (HRQoL) of children and adolescents from the perspective of a parent, caregiver or another proxy. It uses a three-level scale (no problems, some problems or a lot of problems) along with a visual analogue scale (VAS) from 0 (worst imaginable health) to 100 (best imaginable health). The EQ-5D-Y-3L value sets will be used to calculate utility values.
Time frame: Through study completion, an average of 6 months
Group 1 respondents' assessment of Bolt-on vision
Group 1 respondents are parents (or other proxy) of children and adolescents suffering from myopia. The vision bolt-on assessment is an extension to the EQ-5D tool to specifically address the impact of vision impairment on a person's quality of life and consists of a single question in the same format.
Time frame: Through study completion, an average of 6 months
Group 1 respondents' assessment of PedEyeQ (Pediatric Eye Questionnaire)
Group 1 respondents are parents (or other proxy) of children and adolescents suffering from myopia. The PedEyeQ (Pediatric Eye Questionnaire) proxy version is a HRQoL (Health Related Quality of Life) assessment tool specifically designed to measure the impact of pediatric eye conditions on children. The tool consists of age-appropriate questionnaires (5-11 years old and 12-17 years old) that assess how vision problems affect daily activities, social interactions, school performance, and overall well-being of the child.
Time frame: Through study completion, an average of 6 months
Group 2 respondents' assessment of EQ-5D-5L
Group 2 respondents are adult patients suffering from myopia and a long-term complication of myopia. The EQ-5D-5L (European Quality of Life 5 Dimensions 3 Level) includes five questions covering mobility, self-care, usual activities, pain/discomfort and anxiety/depression. This questionnaire will be administered to adults suffering from myopia plus a complication. Each domain is rated from 1 (best quality) to 5 (worst quality), along with a VAS from 0 (worst imaginable health) to 100 (best imaginable health).
Time frame: Through study completion, an average of 6 months
Group 2 respondents' assessment of Bolt-on vision
Group 2 respondents are adult patients suffering from myopia and a long-term complication of myopia. The vision bolt-on is an extension to the EQ-5D tool to specifically address the impact of vision impairment on a person's quality of life. The EQ-5D-5L value sets will be used to calculate utility values for adults with myopia and its complications.
Time frame: Through study completion, an average of 6 months
Group 2 respondents' assessment of NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25)
Group 2 respondents are adult patients suffering from myopia and a long-term complication of myopia. The NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25) is a tool used to assess VRQoL (Vision Related Quality of Life) in individuals aged 18 and older. It consists of 25 items that measure the impact of vision impairment on daily activities and well-being across 12 domains, including visual function, mental health, social functioning, and role limitations. The NEI-VFQ-25 helps evaluate how visual problems affect a person's ability to perform tasks like reading, driving, and interacting socially.
Time frame: Through study completion, an average of 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.