Ignite Creation Date:
2025-12-17 @ 3:40 PM
Ignite Modification Date:
2025-12-23 @ 6:57 PM
Study NCT ID:
NCT00746304
Status:
COMPLETED
Last Update Posted:
2008-09-03
First Post:
2008-08-31
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin
Sponsor:
National Taiwan University Hospital
Organization:
Study Overview
Official Title:
Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin
Status:
COMPLETED
Status Verified Date:
2007-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: