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

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-005068-82-NL

Enrollment

Registered

2012-11-19

Start date

2013-04-08

Completion date

Unknown

Last updated

2013-04-15

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

Conditions

infantile esotropia

Interventions

Trade Name: Botox Product Name: Botox Product Code: RVG 32957 Pharmaceutical Form: Powder for solution for injection INN or Proposed INN: BOTULINUM ANTITOXIN TYPE A Other descriptive name: BOTULINUM A

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Infantile esotropia; age =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Previous strabismus surgery. - Retinal disease. - Any medical condition that would preclude general anesthesia with sevoflurane.

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine the proportion of successful alignment after treatment of infantile esotropia with Botox.;Secondary Objective: Not applicable.;Primary end point(s): - Success rate of alignment. (Successful alignment is defined as = ±10 prism diopters of residual esotropia at 6 months.) - Binocular function. (Bagolini striated glasses, the Lang I test, the Titmus Stereo Test and the fusion range measured in the synoptophore.) ;Timepoint(s) of evaluation of this end point: Preoperatively, and postoperatively at 2 and 10 weeks, at 6 months and at 1 and 2 years.	—

Measure

Time frame

Main Objective: To determine the proportion of successful alignment after treatment of infantile esotropia with Botox.;Secondary Objective: Not applicable.;Primary end point(s): - Success rate of alignment. (Successful alignment is defined as = ±10 prism diopters of residual esotropia at 6 months.) - Binocular function. (Bagolini striated glasses, the Lang I test, the Titmus Stereo Test and the fusion range measured in the synoptophore.) ;Timepoint(s) of evaluation of this end point: Preoperatively, and postoperatively at 2 and 10 weeks, at 6 months and at 1 and 2 years.

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Secondary

Measure	Time frame
Secondary end point(s): 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. ;Timepoint(s) of evaluation of this end point: Preoperatively, and postoperatively at 2 and 10 weeks, at 6 months and at 1 and 2 years.	—

Measure

Time frame

Secondary end point(s): 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. ;Timepoint(s) of evaluation of this end point: Preoperatively, and postoperatively at 2 and 10 weeks, at 6 months and at 1 and 2 years.

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Countries

Netherlands

Contacts

Public ContactRotterdam Ophthalmic Institute

The Rotterdam Eye Hospital

r.wubbels@oogziekenhuis.nl31104023430

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026