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

Khon Kaen University

Status and phase: Unknown; Phase 2

Conditions: Hemifacial Spasm

Treatments: Drug: preseptal injection of botulinum toxin type A; Drug: pretarsal injection of Botulinum toxin type A

Study type: Interventional

Funder types: Other

Identifiers

NCT01564979

KTS-001-BTX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 26 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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26 participants in 2 patient groups

preseptal

Experimental group

Treatment:

Drug: preseptal injection of botulinum toxin type A

pretarsal

Experimental group

Treatment:

Drug: pretarsal injection of Botulinum toxin type A