Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin
1 other identifier
observational
164
1 country
1
Brief Summary
To investigate long-term treatment outcomes of patients receiving botulinum toxin A therapy for infantile and acquired esotropia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2007
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 31, 2008
CompletedFirst Posted
Study publicly available on registry
September 3, 2008
CompletedSeptember 3, 2008
September 1, 2007
1 month
August 31, 2008
August 31, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
1
infantile esotropia
2
acquired esotropia
Eligibility Criteria
A total of 373 patients with strabismus were treated with botulinum toxin injection by a single surgeon (AH Wang) at the Department of Ophthalmology, National Taiwan University Hospital, Taipei, Taiwan from 1992 to 2005.
You may qualify if:
- infantile esotropia and acquired esotropia
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Taiwan University Hospital
Taipei, 100, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tzu-Hsun Tsai, MD
National Taiwan University Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 31, 2008
First Posted
September 3, 2008
Study Start
September 1, 2007
Primary Completion
October 1, 2007
Study Completion
December 1, 2007
Last Updated
September 3, 2008
Record last verified: 2007-09