Protocol summary
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Study aim
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comparison between result of surgery on virgin muscles versus surgery on manipulated muscles in treatment of residual and consecutive esotropia and exotropia
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Design
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24 patients, one by one distributed in virgin muscles group or manipulated muscles group(in two groups of 12 patients),study was single blinded,enrollment time was between 2013 and 2017 and follow up for 3 months after surgery,
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Settings and conduct
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telephone call makes for all patient who had a BMR,BLR or R&R surgery more than six month ago,among those who had a surgery between april2013 and April 2017 in Arvand or Imam khomeini hospital in ahvaz,more than six months ago,those had a consecutive XT,consecutive ET,residual XT or residual ET more than 15 prism diopter are included in the study.nystagmus,refraction,hypertropia ,DVD, A or V pattern along with sex ,amblyopia,number of previous surgeries,are documented for each patient.all patient are operated by same oculoplastic and strabismus surgeon by standard method and no further risk is carried on patients.outcome are documented in 1 and 3 month after surgery .blinding of study is done in analizers(information survey commette).
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Participants/Inclusion and exclusion criteria
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patients with a history of BMR, BLR or R&R surgery, in imam khomeini or arvand hospital , in ahvaz,at least 6 month ago who have a residual or consecutive esotropia or exotropia are included
patients with muscle fibrosis, Duan's syndrome, brown's syndrome, traumatic deviation or those who can't come for 3 month follow up are excluded.
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Intervention groups
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in virgin extra ocular muscles group,based on standard tables,disinsertion ,replacement and reinsertion to new site on sclera is done
in manipulated extra ocular muscles group,based on standard tables,disinsertion ,replacement and reinsertion to new site on sclera is done
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Main outcome variables
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Post operative deviation
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:
IRCT2017082135295N1
Registration date:
2017-08-21, 1396/05/30
Registration timing:
registered_while_recruiting
Last update:
2018-04-18, 1397/01/29
Update count:
1
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Registration date
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2017-08-21, 1396/05/30
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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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ahvaz jondi shaoor university of medical science
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Expected recruitment start date
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2013-08-16, 1392/05/25
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Expected recruitment end date
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2017-10-23, 1396/08/01
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Actual recruitment start date
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2013-08-16, 1392/05/25
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Actual recruitment end date
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2017-10-23, 1396/08/01
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Trial completion date
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empty
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Scientific title
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A clinical trial on the correction of ocular deviation in operation on new extra ocular muscles compare with re-operation on the same Extra ocular muscles used in previous surgery in treatment of Consecutive and Residual esotropia and exotropia
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Public title
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Study of surgical outcome on new extra ocular muscles and re-operation on the same Extra ocular muscle use in previous surgery in Residual and consecutive strabismus
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Among those had a visit in Arvand or Imam khomeini hostpital, patients with a history of six month or more of squint surgery including BMR(bimedial rectus muscle)surgery, or R&R(resection and recession) ,and had a consecutive exotropia, or residual esotropia more than 15 prism diopters
Among those had a visit in Arvand or Imam khomeini hostpital, patients with a history of six month or more of squint surgery including BLR(bilateral lateral rectus muscle)surgery, or R&R(resection and recession) ,and had a consecutive esotropia, or residual exotropia more than 15 prism diopters
Exclusion criteria:
patients with muscle fibrosis
Duan syndrome
Brown syndrome
Traumatic deviation
patients who can't come at least for 3 month of follow up
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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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Sample size
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Target sample size:
24
Actual sample size reached:
24
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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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Single blinded
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Blinding description
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patients are distributed in groups one by one according to time of first visit
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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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sampling is census
Ethics committees
1
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Ethics committee
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Approval date
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2017-07-22, 1396/04/31
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Ethics committee reference number
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IR.AJUMS.REC.1396.374
Health conditions studied
1
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Description of health condition studied
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esotropia,exotropia
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ICD-10 code
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H50.0,H50.
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ICD-10 code description
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Exotropia (alternating)(monocular), except intermittent,v
Primary outcomes
1
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Description
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horizontal deviation after surgery
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Timepoint
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before, 1 month ,three month later
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Method of measurement
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deviation measured as prism diopter with krimski and hirschburg method
2
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Description
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hypertropia
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Timepoint
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before, 1 month ,three month later
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Method of measurement
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deviation measured as prism diopter with krimski and hirschburg method
3
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Description
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Dissociated Vertical Deviation(DVD)
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Timepoint
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before, 1 month ,three month later
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Method of measurement
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deviation measured as prism diopter with krimski and hirschburg method
4
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Description
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nystagmus
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Timepoint
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before, 1 month ,three month later
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Method of measurement
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indirect ophthalmoscopy,or watch patient's eye without aid
5
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Description
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refraction
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Timepoint
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before, 1 month ,three month later
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Method of measurement
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diopter of refractive error measured by autorefractometer or retinoscopy
Secondary outcomes
1
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Description
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residual or consecutive deviation
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Timepoint
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1month,3month after surgery
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Method of measurement
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deviation measured as prism diopter by krimski and hirschburg method
2
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Description
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conjunctival cyst or granuloma
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Timepoint
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1month,3month after surgery
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Method of measurement
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slit lamp examination
Intervention groups
1
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Description
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in intervention group,surgery is performed on extra ocular muscles previously used in BMR,BLR or R&R surgery.standard fornix based conj peritomy is performed,then muscle sutured with vicryl6/0 then cut and based on a standard schedule sutured to sclere.then conjunctival suturing with vicryl6/0 performed.and eye ointment tetracyclin and eye patch is applied.all surgeries is performed by single strabismus and oculoplastic surgeon.
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Category
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Treatment - Surgery
2
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Description
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in control group,surgery is performed on new extra-ocular muscles (virgin muscles).standard fornix based conj peritomy is performed,then muscle sutured with vicryl6/0 then cut and based on a standard schedule sutured to sclere.then conjunctival suturing with vicryl6/0 performed.and eye ointment tetracyclin and eye patch is applied.all surgeries is performed by single strabismus and oculoplastic surgeon.
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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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Ahvaz 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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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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no information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not 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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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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results will be available in thesis
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When the data will become available and for how long
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since thesis was printed
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To whom data/document is available
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both scientific centers and faculty members
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Under which criteria data/document could be used
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as a refrence for other studies
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From where data/document is obtainable
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email:shakari.m@ajums.ac.ir
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What processes are involved for a request to access data/document
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monthy mail box will be checked
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Comments
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