Observational Survey Study on the Impact of Myopia and Its Complications on Quality of Life.

Santen

Status: Enrolling

Conditions: Myopia

Treatments: Other: Non-Intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT06912802

PMA-HEOR-QoL-001

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: 5+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• Parents (or other proxy) of children aged 4 years and below.
• Patients where the complication is likely unrelated to myopia (e.g., cataract caused by diabetes) will be excluded

Trial design

350 participants in 2 patient groups

Childhood Myopia

Description:

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;

Treatment:

Other: Non-Intervention

Adulthood Myopia + Long-Term Complication

Description:

Adults suffering from myopia and its complications such as: cataract, macular degeneration, open-angle glaucoma, retinal detachment, and legal blindness/severe visual impairment.

Treatment:

Other: Non-Intervention