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

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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

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.
    


Study Type

Interventional


Primary Outcome

Changes of Jankovic rating scale (JRS) from baseline at 1week, 1month and 3 months

Secondary Outcome

 Changes of blepharospasm disability index (BSDI) from baseline at 1week, 1month and 3 months

Condition

Blepharospasm

Intervention

Botulinum toxin A injection (5 sites: 12.5U)

Study Arms / Comparison Groups

 medial lower eyelid waived
Description:  Botulinum toxin A 10U per eye subcutaneous injection at orbicularis oculi

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

120

Start Date

February 2013

Completion Date

December 2015

Primary Completion Date

December 2015

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Hui Yang, MD, PhD, +86 13710584767, [email protected]

Location Countries

China

Location Countries

China

Administrative Informations


NCT ID

NCT02327728

Organization ID

ZOC00173


Responsible Party

Sponsor-Investigator

Study Sponsor

YangHui


Study Sponsor

Hui Yang, MD, PhD, Principal Investigator, Zhongshan Ophthalmic Center, SunYat-senU


Verification Date

December 2014