The effect of anterior transposition of the inferior oblique muscle in the treatment of severe superior oblique muscle palsy in
Design
Our study will take place within 18 months from the first of September 2016 to by the end of the 20 March of 2018. All subjects who had entered the study within one year and a half were included in the study as a non-control group in a full-scale study, with about 25-30 eligible for inclusion in the study.
Settings and conduct
Before surgery, the patient's deviation will be accurately calculated and compared with the amount of deviation in the eye after surgery.In this study, the reduction of shedding of eyes equal to or less than 4PD will be considered as a success.Patients entering the study will undergo anterior transposition of inferior oblique surgery.In all patients, one surgeon will be.These patients will be followed up regularly for 3 months after surgery.The latest tracking of information will be collected and analyzed.Post-operative examinations will be performed by someone else.
Participants/Inclusion and exclusion criteria
All patients diagnosed with severe superior oblique muscle palsy (greater than or equal to 20PD), candidates for anterior transposition of the inferior oblique muscle. Exit criteria include: previous operation on the muscles of the mule or vertebrae and bilateral paralysis of the upper shoulder muscle.
Intervention groups
All patients diagnosed with severe superior oblique muscle palsy (greater than or equal to 20PD), candidates for anterior transposition of the inferior oblique muscle.
Main outcome variables
Determine the amount of deviation of the eye before the anterior movement of the lower muscle،Determine the amount of deviation after the anterior movement of the lower muscle،Comparing the amount of deviation before and after the anterior movement of the lower muscle.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180205038625N1
Registration date:2018-05-31, 1397/03/10
Registration timing:retrospective
Last update:2018-05-31, 1397/03/10
Update count:1
Registration date
2018-05-31, 1397/03/10
Registrant information
Name
Ahmad Babaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3668 7162
Email address
sattarish@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
2016-09-22, 1395/07/01
Actual recruitment end date
2018-02-04, 1396/11/15
Trial completion date
empty
Scientific title
The effect of anterior transposition of the inferior oblique muscle in the treatment of severe superior oblique muscle palsy
Public title
The effect of anterior transposition of the inferior oblique muscle in the treatment of severe superior oblique muscle palsy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients diagnosed with severe superior oblique muscle palsy (greater than or equal to 20 PD), candidates for anterior transposition of the inferior oblique muscle ,will be included in the study after obtaining informed consent.
Exclusion criteria:
Exit criteria include: previous operation on the muscles of the mule or vertebrae and bilateral paralysis of the superior oblique muscle
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Actual sample size reached:
30
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz / Azadi Avenue / Golghast Street / Central University of Medical Sciences
City
tabriz
Province
East Azarbaijan
Postal code
5155956853
Approval date
2017-12-04, 1396/09/13
Ethics committee reference number
IR.TBZMED.REC.1396.776
Health conditions studied
1
Description of health condition studied
The effect of anterior transposition of the inferior oblique muscle in the treatment of severe superior oblique muscle palsy
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
All patients with severe paralysis of the superior oblique muscle. have a high deviation of 20 PD in patients with severe deviation.
Timepoint
Before starting the study
Method of measurement
prism
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: All patients diagnosed with severe superior oblique muscle palsy (greater than or equal to 20 PD), candidates for anterior transposition of the inferior oblique muscle ,will be included in the study after obtaining informed consent.A trial study was conducted without control group.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
medical education Eye Center Tabriz Nikokary
Full name of responsible person
Dr. Reza Nabie
Street address
Tabriz-Abbasi Avenue-Nikokary Eye Hospital
City
tabriz
Province
East Azarbaijan
Postal code
5154645395
Phone
+98 41 3657 7330
Email
sattarish@tbzmed.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghasem Jouyban . Ph.D
Street address
Tabriz / Gulgasht Street / Tabriz University of Medical Sciences Department of Research and Technology Deputy Headquarters No. 2 / Third Floor
City
TABRIZ
Province
East Azarbaijan
Postal code
5154645395
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?