Pretarsal Versus Preseptal Botulinum Toxin for Patients With Eyelid Spasm
Blepharospasm, Hemifacial Spasm, Botulinum Toxins, Type A
About this trial
This is an interventional treatment trial for Blepharospasm focused on measuring Eyelid, Dystonia, Botulinum injection, Oculoplastics
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Preseptal-pretarsal
Pretarsal-preseptal
The Preseptal-pretarsal group will receive injections of Botulinum Toxin Type A 100Unit/Vial (Product) in the preseptal site (Injection pattern A) and Saline Solution for Injection (placebo control) in the pretarsal site for 2 cycles at 3 months apart. Both groups will crossover and receive the alternative intervention. Hence in the second half of the trial, the Preseptal-pretarsal group will be injected with BtA in Pattern B and Pretarsal-preseptal group will receive Pattern A.
The Pretarsal-preseptal group will initially receive injections Botulinum Toxin Type A 100Unit/Vial (Product) in the reverse with the intervention at the pretarsal site (Injection pattern B) for 2 cycles at 3 months apart. Groups 1 and 2 will crossover and receive the alternative intervention. Both groups will crossover and receive the alternative intervention. Hence in the second half of the trial, the Preseptal-pretarsal group will be injected with BtA in Pattern B and Pretarsal-preseptal group will receive Pattern A.