Comparison of Different Botulinum Toxin A Injection Patterns in the Treatment of Blepharospasm

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of Different Botulinum Toxin A Injection Patterns in the Treatment of Blepharospasm

Conditions
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Blepharospasm

Intervention / Treatment
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* Procedure: Botulinum toxin A injection (5 sites: 12.5U)
* Procedure: Botulinum toxin A injection (4 sites: 10U)
* Drug: Botulinum toxin A 12.5U
* Drug: Botulinum toxin A 10U


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: medial lower eyelid waived<br>Botulinum toxin A 10U per eye subcutaneous injection at orbicularis oculi | Procedure: Botulinum toxin A injection (4 sites: 10U)<br> <br> Drug: Botulinum toxin A 10U<br> <br> |
| Active Comparator: full injection pattern<br>Botulinum toxin A 12.5U per eye subcutaneous injection at orbicularis oculi | Procedure: Botulinum toxin A injection (5 sites: 12.5U)<br> <br> Drug: Botulinum toxin A 12.5U<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of blepharospasm disability index (BSDI) 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 | 
| Changes of tear break up time (BUT) 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 Schirmer test Ｉ from baseline at 1week, 1month and 3 months |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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blepharospasm, botulinum A, injection pattern, tear