Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00746304

Enrollment

164

Registered

2008-09-03

Start date

2007-09-30

Completion date

2007-12-31

Last updated

2008-09-03

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

Conditions

Esotropia

Keywords

botulinum, esotropia

Brief summary

To investigate long-term treatment outcomes of patients receiving botulinum toxin A therapy for infantile and acquired esotropia.

Detailed description

Participants: 164 patients with infantile esotropia and 89 patients with acquired esotropia. Methods: Patients were injected with botulinum toxin into two medial rectus muscles and followed from 1992 to 2005. Patients were evaluated at 1 week, 2, 6 and 12 months, and then yearly post-injection. Main Outcome Measures: Degree of motor alignment, recurrence rate, incidence of stereopsis, and dissociated vertical deviation along with complications.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

1 Days to 5 Years

Healthy volunteers

Inclusion criteria

* infantile esotropia and acquired esotropia

Exclusion criteria

* exotropia, high AC/A ratio accommodative esotropia, patients with neurological deficit including cerebral palsy, Down syndrome and mental retardation, and ocular anomalies including retinopathy of prematurity. Patients lost to follow-up at 6 months or less after the last injection were also excluded.

Design outcomes

Primary

Measure	Time frame
Degree of motor alignment, recurrence rate, incidence of stereopsis, and dissociated vertical deviation along with complications.	Before treatment, weekly after the treatment, and monthly after motor alignment

Countries

Taiwan

Outcome results