How myopia and its long-term complications affect 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).
This project will collect surveys to see how myopia affects daily life and long-term quality of life for children (reported by parents) and adults with myopia-related complications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 350 (estimated) |
| Ages | 5 Years and up |
| Sex | All |
| Sponsor | Santen SAS Industry-sponsored |
| Locations | 10 sites (Copenhagen and 9 other locations) |
| Trial ID | NCT06912802 on ClinicalTrials.gov |
What this trial studies
This observational survey gathers patient- and proxy-reported health-related quality of life (HRQoL) data from children (via parents) and adults who have myopia and myopia-related complications. The study also collects country-specific information on healthcare resource use, treatment costs, access to care and reimbursement, plus measures of treatment satisfaction and impacts on daily activities. No clinical treatment efficacy or adverse event data are collected. Collected data will be used to populate cost-effectiveness models and inform healthcare planning and policy.
Who should consider this trial
Good fit: Ideal participants are parents or proxies of children aged 5 years and older with low, moderate, or high myopia, and adults with myopia who have complications likely related to myopia such as cataract, macular degeneration, open-angle glaucoma, retinal detachment, or severe visual impairment.
Not a fit: People whose eye complications are likely unrelated to myopia (for example cataracts caused by diabetes), parents of children under age 5, and anyone seeking treatment efficacy or safety data are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the data could help health systems and providers target resources and choose approaches that improve quality of life for people with myopia.
How similar studies have performed: Questionnaire-based HRQoL and resource-use studies have been used successfully in ophthalmology to inform economic models, though large multicountry programs focused specifically on long-term myopia complications are less common.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Copenhagen and 9 other locations
- Copenhagen University Hospital — Copenhagen, Denmark (Not_yet_recruiting)
- University Hospital Necker Enfants Malades — Paris, France (Not_yet_recruiting)
- Klinik für Augenheilkunde (Universitätsklinikum Freiburg) — Freiburg im Breisgau, Germany (Not_yet_recruiting)
- Universitäts-Augenklinik Mainz — Mainz, Germany (Not_yet_recruiting)
- Meyer Children's Hospital IRCCS — Florence, Italy (Recruiting)
- Policlinico Universitario Agostino Gemelli IRCCS — Rome, Italy (Not_yet_recruiting)
- Estudio Oftalmologico — Madrid, Spain (Not_yet_recruiting)
- The San Carlos Clinic Hospital (Hospital Clinico San Carlos-HCSC) — Madrid, Spain (Not_yet_recruiting)
- St. Erik Eye Hospital — Solna, Sweden (Not_yet_recruiting)
- Moorfields Eye Hospital NHS Foundation Trust — London, United Kingdom (Not_yet_recruiting)
Study contacts
- Study coordinator: Santen sas Clinical Operations
- Email: clinicaltrials@santen.com
- Phone: 5106851794
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.