Overview

Low-dose AtropIne for Myopia Control in Children

Status:
Not yet recruiting

Trial end date:
2025-04-01

Target enrollment:
0

Participant gender:
All

Summary

Myopia (nearsightedness) is the most common developmental eye disorder in the first decades of life. It is the biggest risk factor for sight threatening degenerative eye diseases later in life, second only to age. Its prevalence is increasing worldwide in pandemic dimensions affecting now > 80% in Asian and > 40% in Caucasian populations. Myopia is one of the five eye diseases identified as immediate priorities by the WHO's global initiative for the elimination of avoidable blindness. It usually develops during primary school and its onset and progression are related to environmental factors such as near work and lack of day light exposure, to a lesser degree to genetic factors. Therefore, retardation of myopia progression is a major therapeutic goal. Clinical trials from Asia have shown that 0.01% atropine eye drops can attenuate progression of myopia while inducing only little side effects such as light sensitivity and reduced accommodation. However, it is unclear whether this therapy is equally and sufficiently efficacious in a Caucasian population. Due to the increasing prevalence also in Europe and an increasing demand from parents for means to retard myopia progression, the trial is the first European large scale randomized clinical trial investigating the safety and efficacy of 0.01% atropine eye drops in comparison to placebo drops. Such a trial is mandatory to substantiate the increasing off-label prescriptions of low-dose atropine in children and to develop clinical guidelines.

Phase:

Phase 2/Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

University Eye Hospital, Freiburg

Treatments:

Atropine
Ophthalmic Solutions

Criteria

Inclusion Criteria:

- Children aged 6 - 11 years with -1- to -10 diopters (D) myopia

Exclusion Criteria:

- Any organic eye disease, strabismus, astigmatism and / or anisometropia >1.5 D,
prematurity, use of mono- / multifocal contact lenses, pre-treatment with atropine