RecruitingNCT06912802

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

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).


Sponsor

Santen SAS

Enrollment

350 participants

Start Date

Jul 29, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 5 Years

Inclusion Criteria3

  • 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 Criteria2

  • 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

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Interventions

OTHERNon-Intervention

Non-Intervention study


Locations(10)

Copenhagen University Hospital

Copenhagen, Denmark

University Hospital Necker Enfants Malades

Paris, France

Klinik für Augenheilkunde (Universitätsklinikum Freiburg)

Freiburg im Breisgau, Germany

Universitäts-Augenklinik Mainz

Mainz, Germany

Meyer Children's Hospital IRCCS

Florence, Italy

Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Estudio Oftalmologico

Madrid, Spain

The San Carlos Clinic Hospital (Hospital Clinico San Carlos-HCSC)

Madrid, Spain

St. Erik Eye Hospital

Solna, Sweden

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom

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NCT06912802


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