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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

Tracking Information
First Submitted Date August 31, 2008
First Posted Date September 3, 2008
Last Update Posted Date September 3, 2008
Study Start Date September 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 31, 2008)		 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 ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin
Official Title Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Esotropia
Intervention Not Provided
Study Groups/Cohorts
  • 1
    infantile esotropia
  • 2
    acquired esotropia
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 31, 2008)		 164
Original Actual Enrollment Same as current
Actual Study Completion Date December 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Day to 5 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT00746304
Other Study ID Numbers 200709002R
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Tsai Tzu-Hsun, National Taiwan University Hospital
Original Responsible Party Same as current
Current Study Sponsor National Taiwan University Hospital
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Tzu-Hsun Tsai, MD National Taiwan University Hospital
PRS Account National Taiwan University Hospital
Verification Date September 2007