Topical 0.01% Atropine for the Control of Fast Progressing Myopia (Myopie-STOP)

University Hospital, Strasbourg, France

Status and phase: Terminated; Phase 3; Phase 2

Conditions: Childhood; Myopia Progressing

Treatments: Drug: Placebo; Drug: Atropine 0.01%

Study type: Interventional

Funder types: Other

Identifiers

NCT04173780

7343

Details and patient eligibility

About

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).

Enrollment: 60 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 participants in 2 patient groups, including a placebo group

Atropine 0.01%

Experimental group

Treatment:

Drug: Atropine 0.01%

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo