NCT07120165

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 7, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
Last Updated

August 13, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

August 6, 2025

Last Update Submit

August 6, 2025

Conditions

Keywords

Myopiachildrenteenagersatropinelunettescontact lensescombinations

Outcome Measures

Primary Outcomes (1)

  • Database of active treatments for myopia

    Database established with data from children or young adults with active myopia treated with ATROPINE 0.01% eye drops or myopia control spectacles or contact lenses, and their various combinations.

    Month 5

Study Arms (3)

Atropine 0.01%

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

Other: Demographic data collectionOther: Ophthalmological historyOther: Ophthalmological data at each examinationOther: Potential adverse events

DIMS/HAL

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

Other: Demographic data collectionOther: Ophthalmological historyOther: Ophthalmological data at each examinationOther: Potential adverse events

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.

Other: Demographic data collectionOther: Ophthalmological historyOther: Ophthalmological data at each examinationOther: Potential adverse events

Interventions

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

Atropine 0.01%DIMS/HALVarious combined treatments

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

Atropine 0.01%DIMS/HALVarious combined treatments

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

Atropine 0.01%DIMS/HALVarious combined treatments

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

Atropine 0.01%DIMS/HALVarious combined treatments

Eligibility Criteria

AgeUp to 25 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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 will be included.

You may qualify if:

  • 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

You may not qualify if:

  • \- non compliance with treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Étienne

Saint-Etienne, 42100, France

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Marie-Caroline TRONE, Md

    CHU de Saint-Étienne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2025

First Posted

August 13, 2025

Study Start

October 20, 2024

Primary Completion

May 7, 2025

Study Completion

May 7, 2025

Last Updated

August 13, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations