Pretarsal Versus Preseptal Botulinum Toxin for Patients With Eyelid Spasm

• Status: Completed
• Trial end date: 2019-02-20
• Target enrollment: 0
• Participant gender: All

Summary

A triple-masked placebo-controlled trial assessing the efficacy and safety of pretarsal versus preseptal botulinum toxin for patients with eyelid spasm. The investigators hypothesize injection of botulinum toxin into the pretarsal orbicularis oculi muscle will have greater clinical efficacy, better measured quality of life, fewer complications, and better cost effectiveness in comparison to a preseptal pattern of injection.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Hong Kong
• Collaborator: Food and Health Bureau, Hong Kong
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; onabotulinumtoxinA; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Patients over 18 years-of-age

• Clinical diagnosis eyelid dystonia, consisting of either blepharospasm or hemifacial spasm

• Patient wish to have treatment with botulinum toxin type A (BtA).

Exclusion Criteria:

• Patients unable to express their symptoms or history to the extent that they are not able to complete the study questionnaires, such as those suffering from dementia.

• Existence of potential contraindications to BtA treatment:

• Pregnancy

• Breastfeeding

• Prior allergic reaction

• Active infection or inflammation in the treatment area

• Neuromuscular and peripheral neuropathic disease

• Concomitant aminoglycoside therapy

• Patients with poor or unstable general health with activities of daily living severely affected by non-dystonia confounding factors, such as hospitalized or bed bound patients.