An interventional study of Botulinum toxin A injection (5 sites: 12.5U) and Botulinum toxin A injection (4 sites: 10U) in Blepharospasm, sponsored by YangHui. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-30.
Sponsored by YangHui · Not applicable, Interventional, and Treatment
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 .
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.
44 studies on the registry are indexed under Blepharospasm; 1 is open to participants now.
This study's planned enrollment of 120 is above the median of 58 across 31 interventional studies indexed under Blepharospasm.
Browse Blepharospasm studies →This is the only study on the registry with YangHui as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Botulinum toxin A 10U per eye subcutaneous injection at orbicularis oculi
Procedure: Botulinum toxin A injection (4 sites: 10U) · Drug: Botulinum toxin A 10U
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
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
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
This study is status unknown, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.