Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin
Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT00746304
Collaborator
(none)
164
1
3
54.9
Study Details
Study Description
Brief Summary
To investigate long-term treatment outcomes of patients receiving botulinum toxin A therapy for infantile and acquired esotropia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
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.
Study Design
Study Type:
Observational
Actual Enrollment
:
164 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin
Study Start Date
:
Sep 1, 2007
Actual Primary Completion Date
:
Oct 1, 2007
Actual Study Completion Date
:
Dec 1, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 1 infantile esotropia |
|
| 2 acquired esotropia |
Outcome Measures
Primary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Day
to 5 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Taiwan University Hospital | Taipei | Taiwan | 100 |
Sponsors and Collaborators
- National Taiwan University Hospital
Investigators
- Principal Investigator: Tzu-Hsun Tsai, MD, National Taiwan University Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00746304
Other Study ID Numbers:
- 200709002R
First Posted:
Sep 3, 2008
Last Update Posted:
Sep 3, 2008
Last Verified:
Sep 1, 2007