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

Completed

• Conditions: infantile esotropia; squinting; 10030061

• Registration Number: NL-OMON39876
• Lead Sponsor: Oogziekenhuis Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 11 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- Infantile esotropia; age < 6 years,
- No known/established neurological disease.
- No vertical deviation (no upshoots).
- Non-accommodative (less than 3D spherical equivalent hyperopia).
- Up to 40 * esotropia.
- Free alternators.
- Difference in refraction between both eyes * 1.5 D.

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Proportion of successful motor alignment at six months.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Binocular function.<br /><br>Time of onset esotropia.<br /><br>Percentages and duration of ptosis and exotropia (temporary side effects of<br /><br>botulinum injection).<br /><br>Percentages of reinjection and additional alignment surgery.<br /><br>BCVA at each visit and amblyopia.<br /><br>Occurrence of vertical disturbances of ocular motility.<br /><br>Adverse events. </p><br>