Topical 0.01% Atropine for the Control of Fast Progressing Myopia

Phase 2

Terminated

• Conditions: Childhood; Myopia Progressing
• Interventions: Drug: Placebo; Drug: Atropine 0.01%

• Registration Number: NCT04173780
• Lead Sponsor: University Hospital, Strasbourg, France

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-11-20
• Study First Submitted QC: 2019-11-20
• Study First Posted: 2019-11-22
• Study Start: 2020-02-12
• Primary Completion: 2024-05-15
• Study Completion: 2024-06-03
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-28
• Last Update Posted: 2024-08-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Atropine 0.01%	Atropine 0.01%	-

Primary Outcome Measures

Name	Time	Method
Myopia in spherical diopters	3 months	Automatic measurement of myopia in spherical diopters under cycloplegia

Secondary Outcome Measures

Name	Time	Method
Axial length	9 months
Adverse events	3 months
Quality of life questionnaire	3 months

Trial Locations

Locations (1)

CHU de Strasbourg; 🇫🇷 Strasbourg, France