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

Sponsored by:	National Taiwan University Hospital
Information provided by:	National Taiwan University Hospital
ClinicalTrials.gov Identifier:	NCT00746304

Purpose

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

Condition
Esotropia

Drug Information available for: Clostridium botulinum toxin

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

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

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

Keywords provided by National Taiwan University Hospital:

botulinum
esotropia

Study placed in the following topic categories:

Esotropia
Ocular Motility Disorders
Motor neuro-ophthalmic disorders
Botulinum Toxins

Eye Diseases
Strabismus
Ocular motility disorders

Additional relevant MeSH terms:

Anti-Dyskinesia Agents
Therapeutic Uses
Nervous System Diseases

Cranial Nerve Diseases
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009