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CompletedNCT06912802Updated May 22, 2026

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

An observational study in Myopia, sponsored by Santen SAS. Completed at 10 sites in 7 countries. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Santen SAS (part of Santen Pharmaceutical Co., Ltd.) · Observational

Study type
Observational
Model
Cohort
Time perspective
Cross-sectional
Enrollment
344
Ages
5 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Myopia

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03

In context

Myopia

1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.

This study's enrollment of 344 is above the median of 150 across 204 observational studies indexed under Myopia.

Browse Myopia studies →

Lead sponsor

Santen SAS is the lead sponsor of 14 studies on the registry; 2 are open to participants now.

First submitted after Santen Inc. became part of Santen Pharmaceutical Co., Ltd..

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
5 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Cohort
Time perspective
Cross-sectional
Enrollment
344 participants (actual)
Patient registry
No

Groups and cohorts

  • 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;

    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.

    Other: Non-Intervention

Interventions

  • OtherNon-Intervention

    Non-Intervention study

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Through study completion, an average of 6 months

  2. 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.

    Time frame: Through study completion, an average of 6 months

  3. 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.

    Time frame: Through study completion, an average of 6 months

  4. 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).

    Time frame: Through study completion, an average of 6 months

  5. 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.

    Time frame: Through study completion, an average of 6 months

  6. 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.

    Time frame: Through study completion, an average of 6 months

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Study locations

10 sites
  • 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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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jul 2025 to primary completion in Apr 2026, 8 months.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 17, 2025
First posted
Apr 6, 2025
StartActual
Jul 29, 2025
Primary completionActual
Apr 17, 2026
CompletionActual
Apr 17, 2026
Last update
May 22, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06912802
Lead sponsor
Santen SAS
Responsible party
Sponsor
First posted
Apr 6, 2025
Start date
Jul 29, 2025
Primary completion
Apr 17, 2026
Completion
Apr 17, 2026
Last update
May 22, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2026. You cannot join it, but the record below documents what was studied.

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