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

NCT06912802 | Recruiting

• 1 other identifier: PMA-HEOR-QoL-001
• Study Type: observational
• Target: 350
• Locations: 7 countries
• Sites: 10

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  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.

  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).

  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.

  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.

  Through study completion, an average of 6 months

Study Arms (2)

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

Non-Intervention OTHER

Non-Intervention study

Adulthood Myopia + Long-Term Complication; Childhood Myopia

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Santen SAS: lead

Study Sites (10)

Copenhagen University Hospital

Copenhagen, Denmark

NOT YET RECRUITING

University Hospital Necker Enfants Malades

Paris, France

NOT YET RECRUITING

Klinik für Augenheilkunde (Universitätsklinikum Freiburg)

Freiburg im Breisgau, Germany

NOT YET RECRUITING

Universitäts-Augenklinik Mainz

Mainz, Germany

NOT YET RECRUITING

Meyer Children's Hospital IRCCS

Florence, Italy

RECRUITING

Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

NOT YET RECRUITING

Estudio Oftalmologico

Madrid, Spain

NOT YET RECRUITING

The San Carlos Clinic Hospital (Hospital Clinico San Carlos-HCSC)

Madrid, Spain

NOT YET RECRUITING

St. Erik Eye Hospital

Solna, Sweden

NOT YET RECRUITING

Moorfields Eye Hospital NHS Foundation Trust

London, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

Santen sas Clinical Operations

CONTACT

5106851794; clinicaltrials@santen.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: April 6, 2025
• Study Start: July 29, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

SE (1); GB (1); DE (2); ES (2); FR (1); IT (2); DK (1)