Blepharospasm
Conditions
Keywords
blepharospasm, botulinum A, injection pattern, tear
Brief summary
To evaluate the efficacy of different botulinum toxin A injection patterns in treating benign essential blepharospasm and to compare their influence on condition of eye surface .
Detailed description
The authors performed a prospective double-blinded randomised clinical trial of 60 patients with an established diagnosis of benign essential blepharospasm from February 2013 to December 2015. Patients received a full injection pattern of 5 sites on one eye and a medial lower eyelid waived injection pattern of 4 sites on the other eye randomly. They were surveyed on ocular surface disease index (OSDI), Jankovic rating scale (JRS), blepharospasm disability index (BSDI) prior to injection and 1week, 1month and 3 months after injection. At these time points, closure of the eyelid, tear break up time (BUT), Schirmer test Ｉ, and lower lid tear meniscus height (TMH) were also measured.
Interventions
PROCEDUREBotulinum toxin A injection (5 sites: 12.5U)
PROCEDUREBotulinum toxin A injection (4 sites: 10U)
DRUGBotulinum toxin A 12.5U
DRUGBotulinum toxin A 10U
Sponsors
YangHui
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* had a confirmed diagnosis of bilateral BEB * a minimum of 24-week period since the last injection was required for all patients who had previously received multiple injections of BoNT-A.
Exclusion criteria
* blepharospasm of known etiology (caused by medication, injury, etc.) * history of surgical intervention for BEB (myectomy or neurectomy) * current ophthalmologic infection * apraxia of eyelid opening associated with levator palpebrae dysfunction
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of Jankovic rating scale (JRS) from baseline at 1week, 1month and 3 months | 3 months |
| Changes of lower lid tear meniscus height (TMH) from baseline at 1week, 1month and 3 months | 3 months |
Secondary
| Measure | Time frame |
|---|---|
| Changes of tear break up time (BUT) from baseline at 1week, 1month and 3 months | 3 months |
| Changes of blepharospasm disability index (BSDI) from baseline at 1week, 1month and 3 months | 3 months |
| Changes of Schirmer test Ｉ from baseline at 1week, 1month and 3 months | 3 months |
| Changes of closure of the eyelid from baseline at 1week, 1month and 3 months | 3 months |
| Changes of ocular surface disease index (OSDI) from baseline at 1week, 1month and 3 months | 3 months |
Countries
China
Contacts
Primary ContactHui Yang, MD, PhD
Outcome results
None listed