Blepharospasm. Blepharospasm
Conditions
Interventions
Intervention 1: Intervention group 1: under MASPORT injection. Each person is injected in a half of face with 80 units of medicine that contains the chemical composition of botulinum toxin and is manu
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: The patient must have a definitive diagnosis of primary and bilateral blepharospasm. The patient must be over 18 years old. Physical and mental health The ability to make decisions regarding voluntary participation in the study .
Exclusion criteria
Exclusion criteria: Patients who have diseases with a disordered mechanism in the transmission of neuromuscular messages. Patients taking medications that affect neuromuscular transmission. Patients participating in other drug studies or clinical trials. Have an unstable medical condition such as uncontrolled diabetes, high blood pressure, or a history of heart surgery. Patients who are allergic to botulinum toxin type A or the ingredients in the formulation. Those with active infection or inflammation on the face. Pregnant or postpartum women. People who have spasms after surgery or Bell's palsy. Patients with contraindications for botulinum toxin type A (BTX-A).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To investigate the effect of two drugs in the same doses in reducing blepharospasm. Timepoint: At the beginning of the study, the day of injection, 14 days later, 2 months later,3months later and 4 months after injection. Method of measurement: A questionnaire prepared and completed by the doctor and the patient.;Examining the short-acting and long-acting side effects of both drugs, including inflammation, redness, and drooping of the eyelids. Timepoint: At the beginning of the study, the day of injection, 14 days later, 2 months later,3months later and 4 months after injection. Method of measurement: A questionnaire prepared and completed by the doctor and the patient.;Checking the shelf life of two drugs. Timepoint: At the beginning of the study, the day of injection, 14 days later, 2 months later,3months later and 4 months after injection. Method of measurement: A questionnaire prepared and completed by the doctor and the patient.;Checking the need for re-injection and restoration of two drugs at intervals of 2 weeks, 2 months ,3 months and 4 months. Timepoint: At the beginning of the study, the day of injection, 14 days later, 2 months later,3months later and 4 months after injection. Method of measurement: A questionnaire prepared and completed by the doctor and the patient. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactForough Hatami
Tehran University of Medical Sciences
Outcome results
None listed