Previous studies in Thailand have shown that lower doses of BTX-A are as effective as normal doses in patients with blepharospasms and hemifacial spasms. We hypothesized that reducing the dose of BTX-A can reduce various side effects while still providing efficacy that is not inferior to normal injections. Botulinum toxin type A, Benign essential blepharospasm, Jankovic Rating Scale
Conditions
Interventions
The study employed consecutive randomization, with a 1:1 ratio, assigning each participant to one of two study groups. In the control group, a full dose of Dysport was injected into the pretarsal port
s pretarsal part, utilizing 5 units at each injection point, resulting in a total dose of 40 units (20 units per eye).
Active Comparator Drug
Full dose versus half dose of Botulinum toxin A injection
Sponsors
The Faculty of Medicine, Thammasat University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: The study enrolled patients diagnosed with BEB by either a neuro-ophthalmologist or neurologist who had received the most recent BTX-A injection for over three months.
Exclusion criteria
Exclusion criteria: Exclusion criteria encompassed individuals with a documented allergic response to BTX-A and patients displaying other craniofacial dyskinesia conditions such as apraxia of lid opening or facial synkinesis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| frequency and severity using the Jankovic Rating Scale (JRS), latency to response, self-response scale, and patient satisfaction scale at 4 weeks and 12 weeks post-injection At 4 weeks and 12 weeks post-injection JRS was assessed by an investigator who was blind to the patient grouping at the clinic | — |
Secondary
| Measure | Time frame |
|---|---|
| complications of injection in each visit at 4 weeks and 12 weeks post-injection epiphora, dry eye, ptosis, lagophthalmos | — |
Countries
Thailand
Contacts
Public ContactSuntaree Thitiwichienlert
Thammasat University
Outcome results
None listed