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

Esotropia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746304
• Other study ID #: 200709002R
• Status: Completed
• Phase: N/A
• First received: August 31, 2008
• Last updated: August 31, 2008
• Start date: September 2007
• Est. completion date: December 2007

Study information

• Verified date: September 2007
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: December 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Esotropia

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No