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

NCT ID: NCT02327728

Last Updated: 2014-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2015-12-31

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.

Conditions

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Blepharospasm

Keywords

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blepharospasm botulinum A injection pattern tear

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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medial lower eyelid waived

Botulinum toxin A 10U per eye subcutaneous injection at orbicularis oculi

Group Type EXPERIMENTAL

Botulinum toxin A injection (4 sites: 10U)

Intervention Type PROCEDURE

Botulinum toxin A 10U

Intervention Type DRUG

full injection pattern

Botulinum toxin A 12.5U per eye subcutaneous injection at orbicularis oculi

Group Type ACTIVE_COMPARATOR

Botulinum toxin A injection (5 sites: 12.5U)

Intervention Type PROCEDURE

Botulinum toxin A 12.5U

Intervention Type DRUG

Interventions

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Botulinum toxin A injection (5 sites: 12.5U)

Intervention Type PROCEDURE

Botulinum toxin A injection (4 sites: 10U)

Intervention Type PROCEDURE

Botulinum toxin A 12.5U

Intervention Type DRUG

Botulinum toxin A 10U

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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YangHui

OTHER

Sponsor Role lead

Responsible Party

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YangHui

MD, PhD, Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Hui Yang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, SunYat-senU

Locations

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Zhongshan Ophthalmic Center, SunYat-senU

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Hui Yang, MD, PhD

Role: CONTACT

Phone: +86 13710584767

Email: [email protected]

Facility Contacts

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Hui Yang, MD, PhD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 26885381 (View on PubMed)

Other Identifiers

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ZOC00173

Identifier Type: -

Identifier Source: org_study_id