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 in ahvaz
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.those had a consecutive XT,consecutive ET,residual XT or residual ET more than 10 prism diopter are included in the study.nystagmus,refraction, 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).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082135295N1
Registration date:2017-08-21, 1396/05/30
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2017-08-21, 1396/05/30
Registrant information
Name
mohammad saeed shakari
Name of organization / entity
ahvaz jondishapoor university of medical science
Country
Iran (Islamic Republic of)
Phone
+98 61 3222 8076
Email address
shakari.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
ahvaz jondi shaoor university of medical science
Expected recruitment start date
2013-08-16, 1392/05/25
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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 in ahvaz
Public title
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
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:patients with a history of six month or more of squint surgery including BMR(bimedial rectus muscle)surgery,BLR(bilateral lateral rectus muscle) or R&R(resection and recession) among those had a visit in Arvand or Imam khomeini hostpital,and had a consecutive exotropia, consecutive esotrpia ,residual esotropia or residual exotropia more than 10 prism diopters measured by krimski or hirschburg method after confirmation by strabismum and oculoplastic surgeon are included in the study.
Exclusion criteria:patients with duan's syndrome,brown syndrome,traumatic strabismus are excluded from study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
sampling is census
Secondary Ids
1
Registry name
ندارد
Secondary trial Id
ندارد
Registration date
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of deputy of research and technology development of Ahvaz jondoshapoor University o
Street address
ahvaz,city univercity.deputy of research and technology development,ahvaz jondishapoor university of medical science
deviation measured as prism diopter with krimski and hirschburg method
2
Description
hypertropia
Timepoint
before, 1 month ,three month later
Method of measurement
deviation measured as prism diopter with krimski and hirschburg method
3
Description
Dissociated Vertical Deviation(DVD)
Timepoint
before, 1 month ,three month later
Method of measurement
deviation measured as prism diopter with krimski and hirschburg method
4
Description
nystagmus
Timepoint
before, 1 month ,three month later
Method of measurement
indirect ophthalmoscopy,or watch patient's eye without aid
5
Description
refraction
Timepoint
before, 1 month ,three month later
Method of measurement
diopter of refractive error measured by autorefractometer or retinoscopy
Secondary outcomes
1
Description
residual or consecutive deviation
Timepoint
1month,3month after surgery
Method of measurement
deviation measured as prism diopter by krimski and hirschburg method
2
Description
conjunctival cyst or granuloma
Timepoint
1month,3month after surgery
Method of measurement
slit lamp examination
Intervention groups
1
Description
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.
Category
Treatment - Surgery
2
Description
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.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam khomeini hospital
Full name of responsible person
professor gholamreza khtaminia
Street address
ahvaz,24 metri street,imam khomeini hospital,eye ward
City
ahvaz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz Jondishapoor University of Medical Science
Full name of responsible person
dr behzad sharif makhmalzade,deputy of research and technology development
Street address
ahvaz,city universityوdeputy of research and technology development
City
ahvaz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jondishapoor 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
Ahvaz Jondishapoor University of medical science
Full name of responsible person
mohammad saeed shakari
Position
ophthalmology resident
Other areas of specialty/work
Street address
ahvaz,24 metri street.imam khomeini hospital .eye ward
City
ahvaz
Postal code
Phone
+98 61 3222 8076
Fax
+98 61 3222 8076
Email
shakari.m@ajums.ac.irsaeed3131@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jondishapoor University of Medical Science
Full name of responsible person
dr gholamreza khataminia
Position
full professor oculoplastic and strabismus surgery
Other areas of specialty/work
Street address
ahvaz,24 metri street.imam khomeini hospital eye ward