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

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

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 Summary: 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.
Sponsor: YangHui

Current Primary Outcome:

  • Changes of Jankovic rating scale (JRS) from baseline at 1week, 1month and 3 months [ Time Frame: 3 months ]
  • Changes of lower lid tear meniscus height (TMH) from baseline at 1week, 1month and 3 months [ Time Frame: 3 months ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Changes of blepharospasm disability index (BSDI) from baseline at 1week, 1month and 3 months [ Time Frame: 3 months ]
  • Changes of ocular surface disease index (OSDI) from baseline at 1week, 1month and 3 months [ Time Frame: 3 months ]
  • Changes of tear break up time (BUT) from baseline at 1week, 1month and 3 months [ Time Frame: 3 months ]
  • Changes of closure of the eyelid from baseline at 1week, 1month and 3 months [ Time Frame: 3 months ]
  • Changes of Schirmer test Ｉ from baseline at 1week, 1month and 3 months [ Time Frame: 3 months ]


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: December 18, 2014
Date Started: February 2013
Date Completion: December 2015
Last Updated: December 24, 2014
Last Verified: December 2014