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

YangHui

Status: Unknown

Conditions: Blepharospasm

Treatments: Procedure: Botulinum toxin A injection (4 sites: 10U); Drug: Botulinum toxin A 10U; Drug: Botulinum toxin A 12.5U; Procedure: Botulinum toxin A injection (5 sites: 12.5U)

Study type: Interventional

Funder types: Other

Identifiers

NCT02327728

ZOC00173

Details and patient eligibility

About

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 .

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 2 patient groups

medial lower eyelid waived

Experimental group

Description:

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

Treatment:

Procedure: Botulinum toxin A injection (4 sites: 10U)

Drug: Botulinum toxin A 10U

full injection pattern

Active Comparator group

Description:

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

Treatment:

Procedure: Botulinum toxin A injection (5 sites: 12.5U)

Drug: Botulinum toxin A 12.5U