Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| medial lower eyelid waived | Experimental | Botulinum toxin A 10U per eye subcutaneous injection at orbicularis oculi |
|
| full injection pattern | Active Comparator | Botulinum toxin A 12.5U per eye subcutaneous injection at orbicularis oculi |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Botulinum toxin A injection (5 sites: 12.5U) | Procedure |
| ||
| Botulinum toxin A injection (4 sites: 10U) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of Jankovic rating scale (JRS) from baseline at 1week, 1month and 3 months | 3 months | |
| Changes of lower lid tear meniscus height (TMH) from baseline at 1week, 1month and 3 months | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hui Yang, MD, PhD | Contact | +86 13710584767 | yanghui9@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Hui Yang, MD, PhD | Zhongshan Ophthalmic Center, SunYat-senU | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Ophthalmic Center, SunYat-senU | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26885381 | Derived | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001764 | Blepharospasm |
| D022125 | Lacerations |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Procedure |
|
| Botulinum toxin A 12.5U | Drug |
|
| Botulinum toxin A 10U | Drug |
|
| Changes of tear break up time (BUT) from baseline at 1week, 1month and 3 months | 3 months |
| Changes of closure of the eyelid 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 |
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |