Comparison of Different Botulinum Toxin A Injection Patterns in the Treatment of Blepharospasm
Primary Purpose
Blepharospasm
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Botulinum toxin A injection (5 sites: 12.5U)
Botulinum toxin A injection (4 sites: 10U)
Botulinum toxin A 12.5U
Botulinum toxin A 10U
Sponsored by
About this trial
This is an interventional treatment trial for Blepharospasm focused on measuring blepharospasm, botulinum A, injection pattern, tear
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
Sites / Locations
- Zhongshan Ophthalmic Center, SunYat-senURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
medial lower eyelid waived
full injection pattern
Arm Description
Botulinum toxin A 10U per eye subcutaneous injection at orbicularis oculi
Botulinum toxin A 12.5U per eye subcutaneous injection at orbicularis oculi
Outcomes
Primary Outcome Measures
Changes of Jankovic rating scale (JRS) from baseline at 1week, 1month and 3 months
Changes of lower lid tear meniscus height (TMH) from baseline at 1week, 1month and 3 months
Secondary Outcome Measures
Changes of blepharospasm disability index (BSDI) from baseline at 1week, 1month and 3 months
Changes of ocular surface disease index (OSDI) from baseline at 1week, 1month and 3 months
Changes of tear break up time (BUT) from baseline at 1week, 1month and 3 months
Changes of closure of the eyelid from baseline at 1week, 1month and 3 months
Changes of Schirmer test I from baseline at 1week, 1month and 3 months
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02327728
Brief Title
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
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2013 (undefined)
Primary Completion Date
December 2015 (Anticipated)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
YangHui
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Blepharospasm
Keywords
blepharospasm, botulinum A, injection pattern, tear
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
medial lower eyelid waived
Arm Type
Experimental
Arm Description
Botulinum toxin A 10U per eye subcutaneous injection at orbicularis oculi
Arm Title
full injection pattern
Arm Type
Active Comparator
Arm Description
Botulinum toxin A 12.5U per eye subcutaneous injection at orbicularis oculi
Intervention Type
Procedure
Intervention Name(s)
Botulinum toxin A injection (5 sites: 12.5U)
Intervention Type
Procedure
Intervention Name(s)
Botulinum toxin A injection (4 sites: 10U)
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin A 12.5U
Intervention Type
Drug
Intervention Name(s)
Botulinum toxin A 10U
Primary Outcome Measure Information:
Title
Changes of Jankovic rating scale (JRS) from baseline at 1week, 1month and 3 months
Time Frame
3 months
Title
Changes of lower lid tear meniscus height (TMH) from baseline at 1week, 1month and 3 months
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Changes of blepharospasm disability index (BSDI) from baseline at 1week, 1month and 3 months
Time Frame
3 months
Title
Changes of ocular surface disease index (OSDI) from baseline at 1week, 1month and 3 months
Time Frame
3 months
Title
Changes of tear break up time (BUT) from baseline at 1week, 1month and 3 months
Time Frame
3 months
Title
Changes of closure of the eyelid from baseline at 1week, 1month and 3 months
Time Frame
3 months
Title
Changes of Schirmer test I from baseline at 1week, 1month and 3 months
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hui Yang, MD, PhD
Phone
+86 13710584767
Email
yanghui9@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hui Yang, MD, PhD
Organizational Affiliation
Zhongshan Ophthalmic Center, SunYat-senU
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhongshan Ophthalmic Center, SunYat-senU
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hui Yang, MD, PhD
Phone
+86 13710584767
Email
yanghui9@hotmail.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
26885381
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.
Results Reference
derived
Learn more about this trial
Comparison of Different Botulinum Toxin A Injection Patterns in the Treatment of Blepharospasm
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