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

August 31, 2008 updated by: National Taiwan University Hospital
To investigate long-term treatment outcomes of patients receiving botulinum toxin A therapy for infantile and acquired esotropia.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

164

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 5 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
1
infantile esotropia
2
acquired esotropia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Before treatment, weekly after the treatment, and monthly after motor alignment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Investigators

  • Principal Investigator: Tzu-Hsun Tsai, MD, National Taiwan University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

August 31, 2008

First Submitted That Met QC Criteria

August 31, 2008

First Posted (Estimate)

September 3, 2008

Study Record Updates

Last Update Posted (Estimate)

September 3, 2008

Last Update Submitted That Met QC Criteria

August 31, 2008

Last Verified

September 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200709002R

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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