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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01564979

Enrollment

Registered

2012-03-28

Start date

2012-04-30

Completion date

2012-12-31

Last updated

2012-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemifacial Spasm

Keywords

botulinum toxin, facial nerve, hemifacial spasm, tears

Brief 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.

Detailed 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.

Interventions

DRUGpreseptal injection of botulinum toxin type A

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

DRUGpretarsal injection of Botulinum toxin type A

Botulinum toxin type A 2,5 units, 5 points

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
tear break up time	change from baseline in tear break up time at 12 weeks	unit of measure; minutes

Secondary

Measure	Time frame	Description
schirmer's test	change from baseline of schirmer's test at 12 weeks	units of measurement; millimeters

Countries

Thailand

Contacts

Primary Contactkitthisak kitthaweesin, ND

kitthisak@hotmail.com6643348383

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026