MyopiaNCT06912802
Observational Survey Study on the Impact of Myopia and Its Complications on Quality of Life.
An observational study of Myopia, run by Santen SAS at 10 sites in 7 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Myopia
- What is being tested?
- Non-Intervention
- How many people
- 344 participants
- Where
- 10 sitesin 7 countries
- Study dates
- 29 Jul 2025to 17 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
10 sites in 7 countries.
10 sites in 7 countries
Germany2 sites
Klinik für Augenheilkunde (Universitätsklinikum Freiburg)
Freiburg im Breisgau
Universitäts-Augenklinik Mainz
Mainz
Italy2 sites
Meyer Children's Hospital IRCCS
Florence
Policlinico Universitario Agostino Gemelli IRCCS
Rome
Spain2 sites
Estudio Oftalmologico
Madrid
The San Carlos Clinic Hospital (Hospital Clinico San Carlos-HCSC)
Madrid
United Kingdom1 site
Moorfields Eye Hospital NHS Foundation Trust
London
About this study
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).
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.
- Conditions
- Myopia
- Being tested
- Non-Intervention
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-InterventionOther
Non-Intervention study
| Study group | Role | What they receive |
|---|---|---|
| Childhood Myopia | 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; Receives: Other: Non-Intervention | |
| Adulthood Myopia + Long-Term Complication | Adults suffering from myopia and its complications such as: cataract, macular degeneration, open-angle glaucoma, retinal detachment, and legal blindness/severe visual impairment. Receives: Other: Non-Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Group 1 respondents' assessment of EQ-5D-Y-3L (proxy)
Group 1 respondents are parents (or other proxy) of children and adolescents suffering from myopia.
The EQ-5D-Y-3L (European Quality of Life 5 Dimensions 3 Level) proxy version is an instrument used to assess health-related quality of life (HRQoL) of children and adolescents from the perspective of a parent, caregiver or another proxy. It uses a three-level scale (no problems, some problems or a lot of problems) along with a visual analogue scale (VAS) from 0 (worst imaginable health) to 100 (best imaginable health). The EQ-5D-Y-3L value sets will be used to calculate utility values.
Measured: Through study completion, an average of 6 months
Group 1 respondents' assessment of Bolt-on vision
Group 1 respondents are parents (or other proxy) of children and adolescents suffering from myopia.
The vision bolt-on assessment is an extension to the EQ-5D tool to specifically address the impact of vision impairment on a person's quality of life and consists of a single question in the same format.
Measured: Through study completion, an average of 6 months
Group 1 respondents' assessment of PedEyeQ (Pediatric Eye Questionnaire)
Group 1 respondents are parents (or other proxy) of children and adolescents suffering from myopia.
The PedEyeQ (Pediatric Eye Questionnaire) proxy version is a HRQoL (Health Related Quality of Life) assessment tool specifically designed to measure the impact of pediatric eye conditions on children. The tool consists of age-appropriate questionnaires (5-11 years old and 12-17 years old) that assess how vision problems affect daily activities, social interactions, school performance, and overall well-being of the child.
Measured: Through study completion, an average of 6 months
Group 2 respondents' assessment of EQ-5D-5L
Group 2 respondents are adult patients suffering from myopia and a long-term complication of myopia.
The EQ-5D-5L (European Quality of Life 5 Dimensions 3 Level) includes five questions covering mobility, self-care, usual activities, pain/discomfort and anxiety/depression. This questionnaire will be administered to adults suffering from myopia plus a complication. Each domain is rated from 1 (best quality) to 5 (worst quality), along with a VAS from 0 (worst imaginable health) to 100 (best imaginable health).
Measured: Through study completion, an average of 6 months
Group 2 respondents' assessment of Bolt-on vision
Group 2 respondents are adult patients suffering from myopia and a long-term complication of myopia.
The vision bolt-on is an extension to the EQ-5D tool to specifically address the impact of vision impairment on a person's quality of life. The EQ-5D-5L value sets will be used to calculate utility values for adults with myopia and its complications.
Measured: Through study completion, an average of 6 months
Group 2 respondents' assessment of NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25)
Group 2 respondents are adult patients suffering from myopia and a long-term complication of myopia.
The NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25) is a tool used to assess VRQoL (Vision Related Quality of Life) in individuals aged 18 and older. It consists of 25 items that measure the impact of vision impairment on daily activities and well-being across 12 domains, including visual function, mental health, social functioning, and role limitations. The NEI-VFQ-25 helps evaluate how visual problems affect a person's ability to perform tasks like reading, driving, and interacting socially.
Measured: Through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start29 Jul 2025
- Primary completion17 Apr 2026
- Study completion17 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 344 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santen SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912802
- Sponsor's protocol ID
- PMA-HEOR-QoL-001
- Status last verified
- May 2026
- First submitted
- 17 Mar 2025
- Last updated
- 22 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT06912802
- Acronym / sponsor ID
- PMA-HEOR-QoL-001
- Conditions
- Myopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 344 participants (actual)
- Lead sponsor
- Santen SASIndustry (pharma, biotech, devices)
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- 17 Apr 2026 (actual)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Childhood Myopia | – | Other: Non-InterventionParents (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; |
| Adulthood Myopia + Long-Term Complication | – | Other: Non-InterventionAdults suffering from myopia and its complications such as: cataract, macular degeneration, open-angle glaucoma, retinal detachment, and legal blindness/severe visual impairment. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-InterventionNon-Intervention study | Other | Adulthood Myopia + Long-Term Complication, Childhood Myopia |
Primary outcome
Group 1 respondents' assessment of EQ-5D-Y-3L (proxy)
Time frame: Through study completion, an average of 6 months
Group 1 respondents are parents (or other proxy) of children and adolescents suffering from myopia. The EQ-5D-Y-3L (European Quality of Life 5 Dimensions 3 Level) proxy version is an instrument used to assess health-related quality of life (HRQoL) of children and adolescents from the perspective of a parent, caregiver or another proxy. It uses a three-level scale (no problems, some problems or a lot of problems) along with a visual analogue scale (VAS) from 0 (worst imaginable health) to 100 (best imaginable health). The EQ-5D-Y-3L value sets will be used to calculate utility values.
Group 1 respondents' assessment of Bolt-on vision
Time frame: Through study completion, an average of 6 months
Group 1 respondents are parents (or other proxy) of children and adolescents suffering from myopia. The vision bolt-on assessment is an extension to the EQ-5D tool to specifically address the impact of vision impairment on a person's quality of life and consists of a single question in the same format.
Group 1 respondents' assessment of PedEyeQ (Pediatric Eye Questionnaire)
Time frame: Through study completion, an average of 6 months
Group 1 respondents are parents (or other proxy) of children and adolescents suffering from myopia. The PedEyeQ (Pediatric Eye Questionnaire) proxy version is a HRQoL (Health Related Quality of Life) assessment tool specifically designed to measure the impact of pediatric eye conditions on children. The tool consists of age-appropriate questionnaires (5-11 years old and 12-17 years old) that assess how vision problems affect daily activities, social interactions, school performance, and overall well-being of the child.
Group 2 respondents' assessment of EQ-5D-5L
Time frame: Through study completion, an average of 6 months
Group 2 respondents are adult patients suffering from myopia and a long-term complication of myopia. The EQ-5D-5L (European Quality of Life 5 Dimensions 3 Level) includes five questions covering mobility, self-care, usual activities, pain/discomfort and anxiety/depression. This questionnaire will be administered to adults suffering from myopia plus a complication. Each domain is rated from 1 (best quality) to 5 (worst quality), along with a VAS from 0 (worst imaginable health) to 100 (best imaginable health).
Group 2 respondents' assessment of Bolt-on vision
Time frame: Through study completion, an average of 6 months
Group 2 respondents are adult patients suffering from myopia and a long-term complication of myopia. The vision bolt-on is an extension to the EQ-5D tool to specifically address the impact of vision impairment on a person's quality of life. The EQ-5D-5L value sets will be used to calculate utility values for adults with myopia and its complications.
Group 2 respondents' assessment of NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25)
Time frame: Through study completion, an average of 6 months
Group 2 respondents are adult patients suffering from myopia and a long-term complication of myopia. The NEI-VFQ-25 (National Eye Institute Visual Function Questionnaire-25) is a tool used to assess VRQoL (Vision Related Quality of Life) in individuals aged 18 and older. It consists of 25 items that measure the impact of vision impairment on daily activities and well-being across 12 domains, including visual function, mental health, social functioning, and role limitations. The NEI-VFQ-25 helps evaluate how visual problems affect a person's ability to perform tasks like reading, driving, and interacting socially.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopia, run by Santen SAS at 10 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Germany, Italy, Spain, Denmark, France and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Group 1 respondents' assessment of EQ-5D-Y-3L (proxy) (time frame: Through study completion, an average of 6 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.