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

NCT ID: NCT06912802

Last Updated: 2025-08-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

350 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-07-29

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Myopia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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;

Non-Intervention

Intervention Type OTHER

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.

Non-Intervention

Intervention Type OTHER

Non-Intervention study

Interventions

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Non-Intervention

Non-Intervention study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Santen SAS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Copenhagen University Hospital

Copenhagen, , Denmark

Site Status NOT_YET_RECRUITING

University Hospital Necker Enfants Malades

Paris, , France

Site Status NOT_YET_RECRUITING

Klinik für Augenheilkunde (Universitätsklinikum Freiburg)

Freiburg im Breisgau, , Germany

Site Status NOT_YET_RECRUITING

Universitäts-Augenklinik Mainz

Mainz, , Germany

Site Status NOT_YET_RECRUITING

Meyer Children's Hospital IRCCS

Florence, , Italy

Site Status RECRUITING

Policlinico Universitario Agostino Gemelli IRCCS

Rome, , Italy

Site Status NOT_YET_RECRUITING

Estudio Oftalmologico

Madrid, , Spain

Site Status NOT_YET_RECRUITING

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

Madrid, , Spain

Site Status NOT_YET_RECRUITING

St. Erik Eye Hospital

Solna, , Sweden

Site Status NOT_YET_RECRUITING

Moorfields Eye Hospital NHS Foundation Trust

London, , United Kingdom

Site Status NOT_YET_RECRUITING

Countries

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Denmark France Germany Italy Spain Sweden United Kingdom

Central Contacts

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Santen sas Clinical Operations

Role: CONTACT

5106851794

Facility Contacts

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Prof. Kessel

Role: primary

Dr. Bremond-Gignac

Role: primary

Dr. Wolf Lagrèze

Role: primary

Dr. Alexander Schuster

Role: primary

Prof Caputo

Role: primary

Dr. Rizzo

Role: primary

Dr. Donate

Role: primary

Dr. Guemes

Role: primary

Dr. Epstein

Role: primary

Dr. Lofgren

Role: backup

Dr. Annegret Dahlmann-Noor

Role: primary

Other Identifiers

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PMA-HEOR-QoL-001

Identifier Type: -

Identifier Source: org_study_id

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