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

Not Applicable

• Conditions: Blepharospasm
• Interventions: Drug: Botulinum toxin A 10U; Drug: Botulinum toxin A 12.5U

• Registration Number: NCT02327728
• Lead Sponsor: YangHui

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 Timeline

• Study Start: 2013-02
• Status Verified: 2014-12
• Study First Submitted: 2014-12-18
• Study First Submitted QC: 2014-12-24
• Last Update Submitted: 2014-12-24
• Study First Posted: 2014-12-30
• Last Update Posted: 2014-12-30
• Primary Completion: 2015-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
medial lower eyelid waived	Botulinum toxin A 10U	Botulinum toxin A 10U per eye subcutaneous injection at orbicularis oculi
full injection pattern	Botulinum toxin A 12.5U	Botulinum toxin A 12.5U per eye subcutaneous injection at orbicularis oculi

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhongshan Ophthalmic Center, SunYat-senU; 🇨🇳 Guangzhou, Guangdong, China