Clinical trial NCT06912802: Observational Survey Study on the Impact of Myopia and Its Complications on Quality of Life.
Official title: 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).
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myopia
Lead sponsor: Santen SAS
Sponsor class: INDUSTRY
First posted: 2025-04-06
Enrollment: 350
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children or adolescents aged 5 years or older suffering from myopia (low, moderate, or high myopia) and adults suffering from myopia and its complications such as: cataract, macular degeneration, open-angle glaucoma, retinal detachment, and legal blindness/severe visual impairment.

Brief 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 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

Primary outcomes:
measure: Group 1 respondents' assessment of EQ-5D-Y-3L (proxy)
timeFrame: Through study completion, an average of 6 months
measure: Group 1 respondents' assessment of Bolt-on vision
timeFrame: Through study completion, an average of 6 months
measure: Group 1 respondents' assessment of PedEyeQ (Pediatric Eye Questionnaire)
timeFrame: Through study completion, an average of 6 months
measure: Group 2 respondents' assessment of EQ-5D-5L
timeFrame: Through study completion, an average of 6 months
measure: Group 2 respondents' assessment of Bolt-on vision
timeFrame: Through study completion, an average of 6 months
measure: Group 2 respondents' assessment of NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25)
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
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