Long-Term Outcomes in the Treatment of Infantile and Acqu... | NCT00746304

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

NCT00746304

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Sep 3, 2008Estimated

Enrollment

164Actual

Phase

Not provided

Conditions

Esotropia

Interventions

Not provided

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Oct 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Aug 31, 2008

First Submission Date that Met QC Criteria

Aug 31, 2008

First Posted Date

Sep 3, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2008

Last Update Posted Date

Sep 3, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

164Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		infantile esotropia
2		acquired esotropia

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Degree of motor alignment, recurrence rate, incidence of stereopsis, and dissociated vertical deviation along with complications.		Before treatment, weekly after the treatment, and monthly after motor alignment

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

5 Years

Standard Ages

Child

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tzu-Hsun Tsai, MD	National Taiwan University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D004948	Esotropia

Ancestor Terms

ID	Term
D013285	Strabismus
D015835	Ocular Motility Disorders
D003389	Cranial Nerve Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided