Topical 0.01% Atropine for the Control of Fast Progressing Myopia

Status

Terminated

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04173780

Acronym

Myopie-STOP

Enrollment

Registered

2019-11-22

Start date

2020-02-12

Completion date

2024-06-03

Last updated

2024-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood, Myopia Progressing

Keywords

Myopia (Progressing), Childhood, Atropine 0,01%

Brief summary

Myopia prevalence has dramatically increased worldwide in recent years in the general population and among children. Progressive myopia increases gradually with growth until the age of 20-25 years. At the same time, there is a remarkable increase in the prevalence of severe myopia (more than -6 diopters). Severe myopia is associated with many complications, which can lead to blindness. There is thus an increase in the number of myopic patients in general, and severe myopic patients in particular. The management of myopia and its complications is therefore a major public health issue. All the means likely to slow the evolution of myopia (thus to limit the prevalence of strong myopia) must be developed to limit the consequences. 0.01% Atropine seems to be a drug with a great interest to slow down the progression of myopia. The aim of the present study is to evaluate the efficacy at 1 year of 0.01% atropine (1 drop per day administered for 1 year) on the reduction of fast progressing myopia in children aged 4 to 12, compared to a control group (instillation of a placebo).

Interventions

DRUGAtropine 0.01%

1 drop per day in both eyes for 1 year

DRUGPlacebo

1 drop per day in both eyes for 1 year

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

4 Years to 12 Years

Healthy volunteers

Inclusion criteria

Children from 4 to 12 years * Myopia from -1 to -6 * Fast progressing myopia (\>0.75 diopter / year) * Informed consent obtained

Exclusion criteria

Astigmatism \> 1.5 diopters * Anisometropia \> 2 diopters * Concomitant pathology of anterior or posterior segments * Other ocular diseases (Ocular inflammation, strabismus …) * Atropine hypersensitivity or allergy

Design outcomes

Primary

Measure	Time frame	Description
Myopia in spherical diopters	12 months	Automatic measurement of myopia in spherical diopters under cycloplegia

Secondary

Measure	Time frame
Axial length	12 months
Adverse events	12 months
Quality of life questionnaire	12 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026