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

May 19, 2026 updated by: Santen SAS

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

344

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark
        • Copenhagen University Hospital
  • France
      • Paris, France
        • University Hospital Necker Enfants Malades
  • Germany
      • Freiburg im Breisgau, Germany
        • Klinik für Augenheilkunde (Universitätsklinikum Freiburg)
      • Mainz, Germany
        • Universitäts-Augenklinik Mainz
  • Italy
      • Florence, Italy
        • Meyer Children's Hospital IRCCS
      • Rome, Italy
        • Policlinico Universitario Agostino Gemelli IRCCS
  • Spain
      • Madrid, Spain
        • Estudio Oftalmologico
      • Madrid, Spain
        • The San Carlos Clinic Hospital (Hospital Clinico San Carlos-HCSC)
  • Sweden
      • Solna, Sweden
        • St. Erik Eye Hospital
  • United Kingdom
      • London, United Kingdom
        • Moorfields Eye Hospital NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Non-Intervention study
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
Non-Intervention study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, an average of 6 months
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.
Through study completion, an average of 6 months
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.
Through study completion, an average of 6 months
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).
Through study completion, an average of 6 months
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.
Through study completion, an average of 6 months
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.
Through study completion, an average of 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Santen SAS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 29, 2025

Primary Completion (Actual)

April 17, 2026

Study Completion (Actual)

April 17, 2026

Study Registration Dates

First Submitted

March 17, 2025

First Submitted That Met QC Criteria

April 2, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PMA-HEOR-QoL-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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