This study is a clinical trial on clinical effect of Bupivacain injection in orbicularis oculi muscle in patients with facial nerve palsy. The control group of these patients were themselves and the method of this study was befor after. The subjects were cases recruited using the inclusion and exclusion criteria at Farabi eye hospital (Tehran, Iran) clinic from January 2012 to June 2013. Inclusion criterion: patients with partial facial nerve palsy and ocular involvement who referred to us at least 12 weeks after the onset of symptoms. Exclusion criteria: complete facial nerve palsy; traumatic palsy; corneal ulcer; immediate need to surgical intervention; 3rd and 4rth cranial nerve palsy and any type of strabismus. Fifteen patients were selected; after examination and measurement of indexes, bupivacain 0.75(4cc) was injected in pretarsal and preseptal part of orbicullaris oculi muscle of upper and lower lids. This injection was done again after 3 weeks and then after 1, 3, 6 months the patients was visited and indexes were measured. The study outcome was clinical response to treatment and the amount of orbicullaris oculi muscle hypertrophy in improvement of indexes. Primary outcome of this study was the amount of changes in vertical palpebral fissure height in open and close eye after injection.
General information
Acronym
BT7
IRCT registration information
IRCT registration number:IRCT2013022712637N1
Registration date:2013-04-18, 1392/01/29
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-04-18, 1392/01/29
Registrant information
Name
Mahla Shadravan
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5536 9786
Email address
mshadravan.oph@gmail.com
Recruitment status
Recruitment complete
Funding source
Ophthalmology Research Center, Tehran University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2013-04-21, 1392/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical effect of Bupivacain injection in orbicularis oculi muscle in patient with facial nerve palsy.
Public title
Bupivacain injection effect in orbicullaris muscle in partial fascial nerve palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: patients with partial facial nerve palsy and ocular involvement who referred to us at least 12 weeks after the onset of symptoms.
Exclusion criteria: complete facial nerve palsy; traumatic palsy; corneal ulcer; immediate need to surgical intervention; third and forth cranial nerve palsy and any type of strabismus.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ophthalmology Research Center Ethics Committee, Tehran University of Medical Sciences of Tehran Univ
Street address
Qazvin squer, farabi eye hospital
City
Tehran
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
ERC/S/153
Health conditions studied
1
Description of health condition studied
Partial peripheral facial nerve palsy
ICD-10 code
G64
ICD-10 code description
Disorder of peripheral nervous system NOS
Primary outcomes
1
Description
Orbicularis muscle function
Timepoint
One month, 3 months and 6 months after first exam
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Palpebral fissure hight in open and close eye
Timepoint
1, 3 and 6 months after first exam
Method of measurement
milimeter
2
Description
Marginal reflex distance 1 and 2
Timepoint
1, 3 and 6 months after first exam
Method of measurement
milimeter
3
Description
Scleral show in close eye
Timepoint
1, 3 and 6 months after first exam
Method of measurement
milimeter
4
Description
Corneal exposure in closed eye
Timepoint
1, 3 and 6 months after first exam
Method of measurement
milimeter
5
Description
Epiphora and its severity
Timepoint
1, 3 and 6 months after first exam
Method of measurement
Subjective
Intervention groups
1
Description
Four cc bupivacaine 0.75 was injected in pre tarsal and pre septal part of orbicullaris muscle. Two and 4 weeks later this injecion was done again.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Farabi Eye hospital
Full name of responsible person
Mahla Shadravan
Street address
Qazvin squer
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ophthalmology research center of Tehran university of medical science
Full name of responsible person
Dr Ali Sadeghi Tari
Street address
Qazvin squar, Farabi Eye hospital
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ophthalmology research center of Tehran university of medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medica, Farabi eye hospital
Full name of responsible person
Mahla Shadravan
Position
MD, Resident of ophthalmology
Other areas of specialty/work
Street address
Qazvin squer
City
Tehran
Postal code
Phone
+98 21 5540 0003
Fax
+98 21 5540 9092
Email
mshadravan.oph@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sceinces, Farabi eye hospital
Full name of responsible person
Mohammad Taher Rajabi
Position
ophthalmologist. Oculoplastic surgery fellowship
Other areas of specialty/work
Street address
Qazvin squer
City
Tehran
Postal code
Phone
+98 21 5540 0003
Fax
+98 21 5540 9092
Email
mt_rajabi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sceinces, Farabi eye hospital
Full name of responsible person
Mahla Shadravan
Position
MD, Resident of ophthalmology
Other areas of specialty/work
Street address
Qazvin squer
City
Tehran
Postal code
Phone
+98 21 5540 0003
Fax
+98 21 5540 9092
Email
mshadravan.oph@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)