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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39876

Enrollment

Registered

2012-11-19

Start date

2013-12-05

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

infantile esotropia squinting

Interventions

Bilateral injection of Botox in the medial rectus muscle.

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: - Infantile esotropia; age

Exclusion criteria

Exclusion criteria: - Previous strabismus surgery. - Retinal disease. - Any medical condition that would preclude general anesthesia with sevoflurane. - Hypersensitivity to any Botox ingredient. - Muscular disease such as myasthenia gravis or Eaton-Lambert syndrome.

Design outcomes

Primary

Measure	Time frame
Proportion of successful motor alignment at six months.	—

Secondary

Measure	Time frame
Binocular function. Time of onset esotropia. Percentages and duration of ptosis and exotropia (temporary side effects of botulinum injection). Percentages of reinjection and additional alignment surgery. BCVA at each visit and amblyopia. Occurrence of vertical disturbances of ocular motility. Adverse events.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)