Clinical trial NCT04173780: Topical 0.01% Atropine for the Control of Fast Progressing Myopia
Official title: Topical 0.01% Atropine for the Control of Fast Progressing Myopia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Myopia Progressing
Childhood
Keywords: Myopia (Progressing)
Childhood
Atropine 0,01%
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 60
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: Myopia in spherical diopters
timeFrame: 12 months
measure: Myopia in spherical diopters
timeFrame: 9 months
measure: Myopia in spherical diopters
timeFrame: 6 months
measure: Myopia in spherical diopters
timeFrame: 3 months
Secondary outcomes:
measure: Axial length
timeFrame: 12 months
measure: Axial length
timeFrame: 6 months
measure: Axial length
timeFrame: 3 months
measure: Axial length
timeFrame: 9 months
measure: Adverse events
timeFrame: 12 months
measure: Adverse events
timeFrame: 9 months
measure: Adverse events
timeFrame: 6 months
measure: Adverse events
timeFrame: 3 months
measure: Quality of life questionnaire
timeFrame: 12 months
measure: Quality of life questionnaire
timeFrame: 9 months
measure: Quality of life questionnaire
timeFrame: 6 months
measure: Quality of life questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: CHU de Strasbourg
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Arnaud SAUER, MD
role: PRINCIPAL_INVESTIGATOR
References: