Clinical trial NCT02327728: Comparison of Different Botulinum Toxin A Injection Patterns in the Treatment of Blepharospasm
Official title: Comparison of Different Botulinum Toxin A Injection Patterns in the Treatment of Blepharospasm
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Blepharospasm
Keywords: blepharospasm
botulinum A
injection pattern
tear
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2014-12-30
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes of Jankovic rating scale (JRS) from baseline at 1week, 1month and 3 months
timeFrame: 3 months
measure: Changes of lower lid tear meniscus height (TMH) from baseline at 1week, 1month and 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Changes of blepharospasm disability index (BSDI) from baseline at 1week, 1month and 3 months
timeFrame: 3 months
measure: Changes of ocular surface disease index (OSDI) from baseline at 1week, 1month and 3 months
timeFrame: 3 months
measure: Changes of tear break up time (BUT) from baseline at 1week, 1month and 3 months
timeFrame: 3 months
measure: Changes of closure of the eyelid from baseline at 1week, 1month and 3 months
timeFrame: 3 months
measure: Changes of Schirmer test Ｉ from baseline at 1week, 1month and 3 months
timeFrame: 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, SunYat-senU
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, SunYat-senU
name: Hui Yang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang H, Lu J, Zhao X, Ding X, Wang Z, Cai X, Luo Y, Lu L. Comparison of Two Botulinum Neurotoxin A Injection Patterns with or without the Medial Lower Eyelid in the Treatment of Blepharospasm. J Ophthalmol. 2016;2016:5957812. doi: 10.1155/2016/5957812. Epub 2016 Jan 14.