Effect on Tear Functions of Pretarsal and Preseptal Techniques of Botulinum Toxin Type A Injection in Hemifacial Spasm
Phase 2
- Conditions
- Hemifacial Spasm
- Interventions
- Drug: preseptal injection of botulinum toxin type ADrug: pretarsal injection of Botulinum toxin type A
- Registration Number
- NCT01564979
- Lead Sponsor
- Khon Kaen University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 26
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description preseptal preseptal injection of botulinum toxin type A - pretarsal pretarsal injection of Botulinum toxin type A -
- Primary Outcome Measures
Name Time Method tear break up time change from baseline in tear break up time at 12 weeks unit of measure; minutes
- Secondary Outcome Measures
Name Time Method schirmer's test change from baseline of schirmer's test at 12 weeks units of measurement; millimeters
Trial Locations
- Locations (1)
Khon Kaen University
🇹ðŸ‡Muang, Khon Kaen, Thailand