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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified March 2012 by Khon Kaen University.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
kitthisak kitthaweesin, Khon Kaen University Identifier:
First received: March 18, 2012
Last updated: March 27, 2012
Last verified: March 2012
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.

Condition Intervention Phase
Hemifacial Spasm
Drug: preseptal injection of botulinum toxin type A
Drug: pretarsal injection of Botulinum toxin type A
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect on Tear Functions of Pretarsal and Preseptal Techniques of Botulinum Toxin Type A Injection in Hemifacial Spasm

Resource links provided by NLM:

Further study details as provided by Khon Kaen University:

Primary Outcome Measures:
  • tear break up time [ Time Frame: change from baseline in tear break up time at 12 weeks ]
    unit of measure; minutes

Secondary Outcome Measures:
  • schirmer's test [ Time Frame: change from baseline of schirmer's test at 12 weeks ]
    units of measurement; millimeters

Estimated Enrollment: 26
Study Start Date: April 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: preseptal Drug: preseptal injection of botulinum toxin type A
botulinum toxin type A (Botox)2.5 units, 5 points
Other Name: Botox
Experimental: pretarsal Drug: pretarsal injection of Botulinum toxin type A
Botulinum toxin type A 2,5 units, 5 points
Other Name: Botox

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.

Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01564979

Contact: kitthisak kitthaweesin, ND 6643348383

Khon Kaen University Not yet recruiting
Muang, Khon Kaen, Thailand, 40002
Principal Investigator: kitthisak kitthaweesin, MD         
Principal Investigator: Pawat Phusetwong, MD         
Sponsors and Collaborators
Khon Kaen University
Principal Investigator: kitthisak kithaweesin, MD Khon Kaen University
  More Information

Responsible Party: kitthisak kitthaweesin, Assoc Prof, Khon Kaen University Identifier: NCT01564979     History of Changes
Other Study ID Numbers: KTS-001-BTX
Study First Received: March 18, 2012
Last Updated: March 27, 2012

Keywords provided by Khon Kaen University:
botulinum toxin
facial nerve
hemifacial spasm

Additional relevant MeSH terms:
Muscle Cramp
Hemifacial Spasm
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Mouth Diseases
Stomatognathic Diseases
Botulinum Toxins
Botulinum Toxins, Type A
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents processed this record on May 22, 2017