Protocol summary
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Study aim
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The effect of anterior transposition of the inferior oblique muscle in the treatment of severe superior oblique muscle palsy in
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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.
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Intervention groups
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All patients diagnosed with severe superior oblique muscle palsy (greater than or equal to 20PD), candidates for anterior transposition of the inferior oblique muscle.
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Main outcome variables
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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
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20180205038625N1
Registration date:
2018-05-31, 1397/03/10
Registration timing:
retrospective
Last update:
2018-08-20, 1397/05/29
Update count:
1
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Registration date
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2018-05-31, 1397/03/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2016-09-22, 1395/07/01
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Expected recruitment end date
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2018-03-20, 1396/12/29
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Actual recruitment start date
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2016-09-22, 1395/07/01
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Actual recruitment end date
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2018-02-04, 1396/11/15
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Trial completion date
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empty
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Scientific title
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The effect of anterior transposition of the inferior oblique muscle in the treatment of severe superior oblique muscle palsy
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Public title
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The effect of anterior transposition of the inferior oblique muscle in the treatment of severe superior oblique muscle palsy
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
30
Actual sample size reached:
30
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2017-12-04, 1396/09/13
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Ethics committee reference number
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IR.TBZMED.REC.1396.776
Health conditions studied
1
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Description of health condition studied
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The effect of anterior transposition of the inferior oblique muscle in the treatment of severe superior oblique muscle palsy
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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All patients with severe paralysis of the superior oblique muscle. have a high deviation of 20 PD in patients with severe deviation.
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Timepoint
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Before starting the study
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Method of measurement
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prism
Intervention groups
1
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Description
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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.
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Category
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Treatment - Surgery
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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The total potential data can be shared after unidentifiable people
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When the data will become available and for how long
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Start the access period 6 months after printing results.
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To whom data/document is available
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For scholars working in academia
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Under which criteria data/document could be used
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There are no specific conditions for using data or documentation.دا
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From where data/document is obtainable
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Tabriz University of Medical Sciences. Ophthalmology Group
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What processes are involved for a request to access data/document
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Department of Ophthalmology of Nicokary Hospita
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Comments
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