Non-interventional Study to Assess the Impact of Myopia in Childhood and the Long-Term Complications in Adulthood on Health-Related Quality of Life (HRQoL).
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Other
Study Type: Observational
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 5
Healthy Volunteers: f
View:
• Parents (or other proxy) of children or adolescents aged 5 years or older suffering from myopia (low, moderate, or high myopia) defined by their spherical equivalent (SER): Low myopia is from -0.5 D (inclusive) to -3.0 D (inclusive), Moderate myopia is from -3.0 D to -6.0 D (inclusive) and High myopia is \<-6.0 D.
• Adults suffering from myopia and its complications such as: cataract, macular degeneration, open-angle glaucoma, retinal detachment, and legal blindness/severe visual impairment.
• Patients where myopia is a known or likely contributing factor to the complication.
Locations
Other Locations
Denmark
Copenhagen University Hospital
NOT_YET_RECRUITING
Copenhagen
France
University Hospital Necker Enfants Malades
NOT_YET_RECRUITING
Paris
Germany
Klinik für Augenheilkunde (Universitätsklinikum Freiburg)
NOT_YET_RECRUITING
Freiburg Im Breisgau
Universitäts-Augenklinik Mainz
NOT_YET_RECRUITING
Mainz
Italy
Meyer Children's Hospital IRCCS
RECRUITING
Florence
Policlinico Universitario Agostino Gemelli IRCCS
NOT_YET_RECRUITING
Rome
Spain
Estudio Oftalmologico
NOT_YET_RECRUITING
Madrid
The San Carlos Clinic Hospital (Hospital Clinico San Carlos-HCSC)
NOT_YET_RECRUITING
Madrid
Sweden
St. Erik Eye Hospital
NOT_YET_RECRUITING
Solna
United Kingdom
Moorfields Eye Hospital NHS Foundation Trust
NOT_YET_RECRUITING
London
Contact Information
Primary
Santen sas Clinical Operations
clinicaltrials@santen.com
5106851794
Time Frame
Start Date:2025-07-29
Estimated Completion Date:2025-12
Participants
Target number of participants:350
Treatments
Childhood Myopia
Parents (or other proxy) of children or adolescents aged 5 years or older suffering from myopia (low, moderate, or high myopia) defined by their refractive error;
Adulthood Myopia + Long-Term Complication
Adults suffering from myopia and its complications such as: cataract, macular degeneration, open-angle glaucoma, retinal detachment, and legal blindness/severe visual impairment.