Effectiveness of Myopia Control Interventions : A Comparison of Myopia Control in European Children, Adolescents and Young Adults With Defocus Incorporated Multiple Segments (DIMS) and Highly Aspherical Lenslets (HAL) Spectacles, Atropine, Lenses and Combined Treatments

NCT ID: NCT07120165

Last Updated: 2025-08-13

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

COMPLETED

Total Enrollment

114 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-20

Study Completion Date

2025-05-07

Brief Summary

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The prevalence of myopia and its complications has risen considerably in recent decades, particularly among children and teenagers. This trend is also spreading in Europe, driven by the increase in screen time and the intensive use of new technologies and social media, particularly among the younger generation.

Several treatment options are available today, including pharmacological treatments with atropine eye drops, as well as optical myopia control systems in the form of glasses or contact lenses.

These different treatments have been used in clinical practice at Saint-Étienne University Hospital since 2017 for atropine, and more recently with the development of optical myopia control systems and their combinations.

Little clinical data has been published to date on these different treatment combinations in the French population.

The investigators would therefore like to set up a database to publish their results and share their experience.

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

RETROSPECTIVE

Study Groups

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Atropine 0.01%

Children or young adults with active myopia treated with ATROPINE 0.01% eye drops.

Demographic data collection

Intervention Type OTHER

Demographic data collection: age, gender, level of education/study, time spent in near vision, sports practice, medical history

Ophthalmological history

Intervention Type OTHER

Ophthalmological history: age of myopia discovery, parental refraction, previous refractions, presence of a braking treatment

Ophthalmological data at each examination

Intervention Type OTHER

Ophthalmological data at each examination: visual acuity, subjective refraction, cycloplegia with SKIACOL, axial length.

Potential adverse events

Intervention Type OTHER

Potential adverse events: halos, photophobia, stinging, infections, etc.

DIMS/HAL

Children or young adults with active myopia treated with myopia control glasses.

Demographic data collection

Intervention Type OTHER

Demographic data collection: age, gender, level of education/study, time spent in near vision, sports practice, medical history

Ophthalmological history

Intervention Type OTHER

Ophthalmological history: age of myopia discovery, parental refraction, previous refractions, presence of a braking treatment

Ophthalmological data at each examination

Intervention Type OTHER

Ophthalmological data at each examination: visual acuity, subjective refraction, cycloplegia with SKIACOL, axial length.

Potential adverse events

Intervention Type OTHER

Potential adverse events: halos, photophobia, stinging, infections, etc.

Various combined treatments

Children or young adults with active myopia treated with ATROPINE 0.01% eye drops or myopia control glasses or contact lenses, and their various combinations.

Demographic data collection

Intervention Type OTHER

Demographic data collection: age, gender, level of education/study, time spent in near vision, sports practice, medical history

Ophthalmological history

Intervention Type OTHER

Ophthalmological history: age of myopia discovery, parental refraction, previous refractions, presence of a braking treatment

Ophthalmological data at each examination

Intervention Type OTHER

Ophthalmological data at each examination: visual acuity, subjective refraction, cycloplegia with SKIACOL, axial length.

Potential adverse events

Intervention Type OTHER

Potential adverse events: halos, photophobia, stinging, infections, etc.

Interventions

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Demographic data collection

Demographic data collection: age, gender, level of education/study, time spent in near vision, sports practice, medical history

Intervention Type OTHER

Ophthalmological history

Ophthalmological history: age of myopia discovery, parental refraction, previous refractions, presence of a braking treatment

Intervention Type OTHER

Ophthalmological data at each examination

Ophthalmological data at each examination: visual acuity, subjective refraction, cycloplegia with SKIACOL, axial length.

Intervention Type OTHER

Potential adverse events

Potential adverse events: halos, photophobia, stinging, infections, etc.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Children or young adults with active myopia treated with ATROPINE 0.01% eye drops or myopia control glasses or contact lenses, and their various combinations
* patient affiliated with a social security organization
* agreement of both parents or the patient if adult

Exclusion Criteria

\- non compliance with treatment
Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marie-Caroline TRONE, Md

Role: PRINCIPAL_INVESTIGATOR

CHU de Saint-Étienne

Locations

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CHU de Saint-Étienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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IRBN1022025/CHUSTE

Identifier Type: -

Identifier Source: org_study_id

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