Observational Survey Study on the Impact of Myopia and Its Complications on Quality of Life. (NCT06912802) | Clinical Trial Compass
CompletedNot Applicable
Observational Survey Study on the Impact of Myopia and Its Complications on Quality of Life.
Denmark, France, Germany344 participantsStarted 2025-07-29
Plain-language 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.
Who can participate
Age range
5 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Group 1 respondents' assessment of EQ-5D-Y-3L (proxy)
Timeframe: Through study completion, an average of 6 months
2
Group 1 respondents' assessment of Bolt-on vision
Timeframe: Through study completion, an average of 6 months
3
Group 1 respondents' assessment of PedEyeQ (Pediatric Eye Questionnaire)
Timeframe: Through study completion, an average of 6 months
4
Group 2 respondents' assessment of EQ-5D-5L
Timeframe: Through study completion, an average of 6 months
5
Group 2 respondents' assessment of Bolt-on vision
Timeframe: Through study completion, an average of 6 months
6
Group 2 respondents' assessment of NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25)
Timeframe: Through study completion, an average of 6 months