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Completed

NCT Number: NCT00746304

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

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

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Key information

Conditions

Esotropia Cranial Nerve Diseases Eye Diseases Nervous System Diseases Ocular Motility Disorders Strabismus

Age range

1 day–5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Registry information

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Sep 3, 2008
Registry last updated
Sep 3, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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