The purpose of the study is to evaluate if strabismus can be successfully treated requiring
less surgical interventions with a Botox-based treatment regimen compared to a purely surgery
based treatment regimen.
Experimental arm: Botulinum toxin injection in the horizontal extraocular muscles.
Control (active comparator) arm: Strabismus surgery on the horizontal extraocular muscles. No
investigational product is used.
In Switzerland the standard procedure for treating large angle esotropia is surgery, which is
performed on the horizontal eye muscles that may be either recessed or shortened leading to
reduced or increased muscle function respectively.
As an alternative to strabismus surgery, botulinum toxin (Botox) can be applied in
extraocular muscles. Botox prevents the release of acetylcholine in the synaptic cleft and
thereby blocks the neuromuscular transmission thus inducing a palsy.
Current evidence on the use of Botox in strabismus is incoherent, is poorly supported by
basic research findings and leaves dedicated clinicians in the dark. The objective is to shed
light into this field of clinical research, which may help to guide future pediatric
ophthalmologists in their management of strabismic patients. In a best case scenario, the
results from this trial will prevent strabismus operation for many children with acquired
large angle esotropia.
Phase:
Phase 3
Details
Lead Sponsor:
University Hospital Inselspital, Berne
Treatments:
abobotulinumtoxinA Botulinum Toxins Botulinum Toxins, Type A onabotulinumtoxinA