An alternative approach for treatment of infantile esotropia with botulinum toxin A.

Rationale:

In comparison to standard strabism surgery in patients with infantile esotropia, bilateral injection of Botox in the medial rectus muscle is conjectured to be equivalent with respect to motor alignment, while burden and risk are (because less invasive) expected to be less.



Objective:

To determine the proportion of successful alignment after treatment of infantile esotropia with Botox.



Study design:

Prospective case series.



Study population:

Infantile esotropia < 6 years of age.



Intervention:

Bilateral injection of Botox in the medial rectus muscle.



Main study parameters/endpoints:

Proportion of successful motor alignment at six months.



Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

As an alternative to conventional strabism surgery, treatment with Botox may be equally effective while both burden and risk are anticipated to be reduced.

The proportion of successful alignment after treatment of infantile esotropia with Botox is not inferior to conventional strabism surgery.

Preoperatively, postoperatively at 2 and 10 weeks, at 6 months and at 1 and 2 years.

Bilateral injection of Botox in the medial rectus muscle.