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

Hemifacial Spasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01564979
• Other study ID #: KTS-001-BTX
• Status: Unknown status
• Phase: Phase 2
• First received: March 18, 2012
• Last updated: March 27, 2012
• Start date: April 2012
• Est. completion date: December 2012

Study information

• Verified date: March 2012
• Source: Khon Kaen University
• Contact: kitthisak kitthaweesin, ND
• Phone: 6643348383
• Email: kitthisak[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 26
• Est. completion date: December 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemifacial Spasm
• Muscle Cramp
• Spasm

Intervention

Drug:
• preseptal injection of botulinum toxin type A
botulinum toxin type A (Botox)2.5 units, 5 points
• pretarsal injection of Botulinum toxin type A
Botulinum toxin type A 2,5 units, 5 points

Locations

Country	Name	City	State
Thailand	Khon Kaen University	Muang	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tear break up time	unit of measure; minutes	change from baseline in tear break up time at 12 weeks
Secondary	schirmer's test	units of measurement; millimeters	change from baseline of schirmer's test at 12 weeks