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

December 24, 2014 updated by: YangHui
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 .

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Recruiting
        • Zhongshan Ophthalmic Center, SunYat-senU
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

YangHui

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

December 18, 2014

First Submitted That Met QC Criteria

December 24, 2014

First Posted (Estimate)

December 30, 2014

Study Record Updates

Last Update Posted (Estimate)

December 30, 2014

Last Update Submitted That Met QC Criteria

December 24, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZOC00173

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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