Benign Essential Blepharospasm (BEB). Blepharospasm
Conditions
Interventions
Intervention 1: Injection of Iranian product of Botulinom Toxin A with commercial name, MASPORT.[masoondarou.com] it contains 500 units of botulinum toxin A that is diluted by 3.2 CC sodium chloride
Sponsors
Shahid Beheshti University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Clinically diagnosed with BEB Without prior BTX-A injection in the previous 6 month History of previous eyelid surgery
Exclusion criteria
Exclusion criteria: pregnancy or lactation secondary causes of Blepharospasm History of disorders of the neuromuscular junction like myasthenia gravis, Eaton-Lambert Syndrome, and psychological instability prescription of antispastic, muscle relaxants or medications affecting neuromuscular junction transmission such as aminoglycosides
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Advance in the severity and frequency grades of spasms (more than at least one grade improvement in severity score. Timepoint: Four weeks post-injection phase. Method of measurement: Based on Severity and Frequency Spasm Score. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Functional Visual Status (FVS). Timepoint: 4, 8, 12 and 16 weeks post-injection. Method of measurement: Functional Visual Status based on the Jankovic Rating Scale (JRS) and functional visual status (FVS) grading table.;Onset of response (denoting the period between the injection and the initial indication of improvement following treatment). Timepoint: 4, 8, 12 and 16 weeks post-injection. Method of measurement: The time that the patient states that the symptoms of recovery have appeared.;The duration of effect (representing the time lapse between the first noticeable clinical impact and the point at which the patient sensed the necessity for further treatment and improvement from the patient perspective). Timepoint: 4, 8, 12 and 16 weeks post-injection. Method of measurement: The period of time fom injection to the time that patient claim to observe improvement symptoms.;Need for retreatment (the point at which the ophthalmologist diagnosed that the patient needs for retreatment). Timepoint: 4, 8, 12 and 16 weeks post-injection. Method of measurement: The period of time fom injection to the time that ophthalmologist consider reinjection for the patient.;Blepharospasm severity improvement (equal and more than one grade). Timepoint: 4, 8, 12 and 16 weeks post-injection. Method of measurement: Based on the Severity of spasm grading table , Jankovic Rating Scale (JRS).;Blepharospasm frequency improvement ( equal and more than one grade). Timepoint: 4, 8, 12 and 16 weeks post-injection. Method of measurement: Based on the Frequency of spasm grading table , Jankovic Rating Scale (JRS). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNazanin Behnaz
Shahid Beheshti University of Medical Sciences
Outcome results
None listed