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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00746304
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : September 3, 2008
Sponsor:
Information provided by:
National Taiwan University Hospital

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

Condition or disease
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.

Study Design
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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 : September 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
1
infantile esotropia
2
acquired esotropia


Outcome Measures
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Primary Outcome Measures :
  1. Degree of motor alignment, recurrence rate, incidence of stereopsis, and dissociated vertical deviation along with complications. [ Time Frame: Before treatment, weekly after the treatment, and monthly after motor alignment ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Day to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00746304


Locations
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Taiwan
National Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Tzu-Hsun Tsai, MD National Taiwan University Hospital
More Information
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Responsible Party: Tsai Tzu-Hsun, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00746304    
Other Study ID Numbers: 200709002R
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: September 3, 2008
Last Verified: September 2007
Keywords provided by National Taiwan University Hospital:
botulinum
esotropia
Additional relevant MeSH terms:
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Esotropia
Strabismus
Ocular Motility Disorders
 Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases