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

This study has been completed.
Sponsor:
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00746304
First received: August 31, 2008
Last updated: NA
Last verified: September 2007
History: No changes posted
  Purpose

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


Condition
Esotropia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Long-Term Outcomes in the Treatment of Infantile and Acquired Esotropia With Botulinum Toxin

Resource links provided by NLM:


Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 164
Study Start Date: September 2007
Study Completion Date: December 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
infantile esotropia
2
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.

  Eligibility

Ages Eligible for Study:   up to 5 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00746304

Locations
Taiwan
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
  More Information

No publications provided

Responsible Party: Tsai Tzu-Hsun, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00746304     History of Changes
Other Study ID Numbers: 200709002R
Study First Received: August 31, 2008
Last Updated: August 31, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
botulinum
esotropia

Additional relevant MeSH terms:
Esotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014