Effect on Tear Functions of Pretarsal and Preseptal Techniques of Botulinum Toxin Type A Injection in Hemifacial Spasm

NCT ID: NCT01564979

Last Updated: 2012-03-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-30

Study Completion Date

2012-12-31

Brief Summary

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The purpose of this study is to determine whether pretarsal and preseptal techniques of Botulinum toxin type A injection have any effect on tear functions.

Detailed Description

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Botulinum toxin type A has been used for hemifacial spasm since 1986. of Botulinum toxin type A can be subcutaneously injected at pretarsal or preseptal portion of orbicularis muscle. Blepharoptosis has been reported less frequently with pretarsal technique, however dry eye was noticed in one patient treated with pretarsal botulinum toxin type A for cosmetic purpose.

Conditions

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Hemifacial Spasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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preseptal

Group Type EXPERIMENTAL

preseptal injection of botulinum toxin type A

Intervention Type DRUG

botulinum toxin type A (Botox)2.5 units, 5 points

pretarsal

Group Type EXPERIMENTAL

pretarsal injection of Botulinum toxin type A

Intervention Type DRUG

Botulinum toxin type A 2,5 units, 5 points

Interventions

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preseptal injection of botulinum toxin type A

botulinum toxin type A (Botox)2.5 units, 5 points

Intervention Type DRUG

pretarsal injection of Botulinum toxin type A

Botulinum toxin type A 2,5 units, 5 points

Intervention Type DRUG

Other Intervention Names

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Botox Botox

Eligibility Criteria

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Inclusion Criteria

* patient diagnosed with hemifacial spasm

Exclusion Criteria

* previous history of botulinum toxin treatment for hemifacial spasm
* ocular surface disorders
* tear disorders
* evidence of infection at or around eyelids
* pregnant woman
* other neurologic disease, i.e. OMG
* coagulopathy or treatment with thrombolytic agent
* treatment with aminoglycosides, chloroquine, hydroxychloroquine
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Khon Kaen University

OTHER

Sponsor Role lead

Responsible Party

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kitthisak kitthaweesin

Assoc Prof

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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kitthisak kithaweesin, MD

Role: PRINCIPAL_INVESTIGATOR

Khon Kaen University

Locations

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Khon Kaen University

Muang, Changwat Khon Kaen, Thailand

Site Status

Countries

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Thailand

Central Contacts

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kitthisak kitthaweesin, ND

Role: CONTACT

6643348383

References

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Price J, O'Day J. A comparative study of tear secretion in blepharospasm and hemifacial spasm patients treated with botulinum toxin. J Clin Neuroophthalmol. 1993 Mar;13(1):67-71.

Reference Type RESULT
PMID: 8501266 (View on PubMed)

Other Identifiers

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KTS-001-BTX

Identifier Type: -

Identifier Source: org_study_id

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