History
# Registration date Revision Id
2 2018-04-06, 1397/01/17 42715
1 2017-08-21, 1396/05/30 26717
Changes made to previous revision
  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents
  • Protocol summary

    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).
    empty
    فراخوان(از طریق تماس تلفنی) برای بیمارانی که بیش از شش ماه قبل، تحت عمل عضلات خارج چشمی قرار گرفته اند جهت اسکرین و ورود به مطالعه بعد از تایید استاد استرابیسم انجام میشوداز بین بیماران مراجعه کننده به بیمارستان امام خمینی (ره) اهواز و بیمارستان اروند از فروردین 92تا فروردین96که به دنبال عمل جراحی قبلی BMR یا عمل R&R دچار کانسکیوتیو اگزوتروپی بیش از 10 پریسم دیوپتر (با روش هیرشبرگ و کریمسکی) شده اند بیماران کاندید عمل جراحی انتخاب میشوند و نیزاز بین بیماران دچار کانسکیوتیو ایزوتروپی با سابقه عمل BLR یا عمل R&R بیش از 10 پریسم دیوپتر بیماران کاندید عمل جراحی انتخاب میشوندو ایزوتروپی باقیمانده بعد از BMR یا عمل R&R یا اگزوتروپی باقیمانده بعد از BLR یا عمل R&R شده باشند میزان انحراف، سن،جنس،تعداد عمل جراحی قبلی،وجودآمبلیوپیا،وجودDVD،هایپرتروپی،نیستاگموس،ریفراکشن،وجود پاترن A یا V برای هر بیمار ثبت میشود.نمونه برداری به روش سرشماری انجام میشود و نیازی به تعیین حجم نمونه نمیباشد.برای بیماران عمل مجدد روی عضلات خارج چشمی یا عمل عضلات خارج چشمی جدید برای درمان کانسکیوتیو اگزوتروپی، درمان کانسکیوتیو ایزوتروپی، درمان ایزوتروپی باقیمانده یا درمان اگزوتروپی باقیمانده به روش استاندارد توسط جراح انجام میشود و نتایج حاصله یک وسه ماه بعدبررسی میشود. شایان ذکر است هر دو روش عمل، اعم از عمل عضلات خارج چشمی دستکاری نشده و عمل عضلات خارج چشمی جدید ،درمان استاندارد انحرافات چشمی هستند و به طور روتین انجام میشوند و ریسک اضافه ای به بیمار تحمیل نمیکند و جراحی تمام بیماران توسط یک جراح فوق تخصص استرابیسم انجام میشود.کورسازی در کمیته پایش اطلاعات (تحلیل کنندگان)صورت میگیرد.
    empty
    empty
    comparison between result of surgery on virgin muscles versus surgery on manipulated muscles in treatment of residual and consecutive esotropia and exotropia
    empty
    مقایسه نتایج عمل روی عضلات دستکاری نشده با نتایج عمل روی عضلات قبلا عمل شده در درمان ایزوتروپی و اگزوتروپی باقیمانده و کانسکیوتیو
    empty
    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,
    empty
    24 بیمار به صورت یک در میان در گروه عضلات دستکاری نشده و گروه عضلات عمل شده قرار گرفتند(دو گروه دوازده نفری)،مطالعه به صورت کار آزمایی یک سو کور و زمان بیمار گیری از 92 تا 96 بود و پیگیری سه ماهه بعد از عمل جراحی انجام شد.
    empty
    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).
    empty
    بیمارانی که بیش از شش ماه قبل،دربیمارستان امام خمینی (ره) اهواز و بیمارستان ارونداز فروردین 92تا فروردین96تحت عمل عضلات خارج چشمی قرار گرفته اندکه به دنبال عمل جراحی قبلی BMR،BLR یاR&R دچار کانسکیوتیو یا باقیمانده بیش از 15 پریسم دیوپتر شده اند بیماران کاندید عمل جراحی انتخاب میشوند میزان انحراف، سن،،تعداد عمل قبلی،آمبلیوپیا،DVD،هایپرتروپی،نیستاگموس،ریفرکشن،وجود پاترن A یا Vهر بیمار ثبت میشود.عمل دوگروه توسط یک جراح انجام میشود و نتایج حاصله یک وسه ماه بعدبررسی میشود.هردو روش عمل،درمان استاندارد انحرافات چشمی هستندوریسک اضافه ای به بیمارتحمیل نمیکند وجراحی تمام بیماران توسط یک جراح فوق تخصص استرابیسم انجام میشود.کورسازی در کمیته پایش اطلاعات(تحلیل کنندگان)صورت میگیرد.
    empty
    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.
    empty
    بیماران با سابقه بیش از شش ماه از عمل BMR,BLR یا R&R در بیمارستان امام خمینی (ره)یا اروند اهواز که دچار ایزوتروپی یا اگزوتروپی باقیمانده یا کانسکیوتیو شده اند و حداقل 15 پریسم دیوپتر انحراف دارند وارد مطالعه میشوند. بیماران با فیبروز عضلانی،سندروم دوان،سندروم براون،انحراف تروماتیک یا عدم توانایی پیگیری برای حداقل سه ماه از مطالعه حذف میشوند
    empty
    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
    empty
    در گروهی که عضلات خارج چشمی قبلا دستکاری نشده است طبق جداول استاندارد،جدا کردن عضلات از محل اتصال خود،مقدار مشخصی از جابجایی عضلات و سپس اتصال مجدد آن به محل جدید روی صلبیه ی چشم انجام میگیرد در گروه عضلات خارج چشمی قبلا عمل شده نیز طبق جداول استاندارد جدا کردن عضلات از محل اتصال خود،مقدار مشخصی از جابجایی عضلات و سپس اتصال مجدد آن به محل جدید روی صلبیه ی چشم انجام میگیرد
    empty
    Post operative deviation
    empty
    میزان انحراف بعد ازعمل
  • General information

    1
    20
    24
    empty
    24
    empty
    2013-08-16, 1392/05/25
    empty
    2017-10-23, 1396/08/01
    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
    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
    گزارش " نتایج عمل" روی عضلات خارج چشمی دستکاری نشده و نتایج عمل مجدد روی عضلات خارج چشمی قبلا عمل شده، در "درمان انحرافات چشمی" باقی مانده یا انحرافات چشمی ناشی از عمل عضلات خارج چشمی
    گزارش نتایج عمل روی عضلات خارج چشمی دستکاری نشده و نتایج عمل مجدد روی عضلات خارج چشمی قبلا عمل شده، در "درمان انحرافات چشمی" باقی مانده یا انحرافات چشمی ناشی از عمل عضلات خارج چشمی
    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
    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
    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
    بیماران مراجعه کننده به بیمارستان امام خمینی (ره) اهواز و بیمارستان اروند که به دنبال عمل جراحی قبلی BMR یا عمل R&R دچار کانسکیوتیو اگزوتروپی یا ایزوتروپی باقیمانده بیش از 15 پریسم دیوپتر (با روش هیرشبرگ و کریمسکی) شده اند و حداقل بیش از شش ماه از زمان عمل آن ها میگذرد
    بیماران مراجعه کننده به بیمارستان امام خمینی (ره) اهواز و بیمارستان اروند که به دنبال عمل جراحی قبلی BLR یا عمل R&R دچارکانسکیوتیو ایزوتروپی یا اگزوتروپی باقیمانده بیش از 15 پریسم دیوپتر بیماران کاندید عمل جراحی انتخاب میشوند
    patients with muscle fibrosis
    Duan syndrome
    Brown syndrome
    Traumatic deviation
    patients who can't come at least for 3 month of follow up
    بیماران با فیبروز عضلانی
    سندروم دوان
    سندروم براون
    انحراف در اثر تروما
    یمارانی که در پیگیری حداقل سه ماهه نتوانند شرکت کنند
    empty
    patients are distributed in groups one by one according to time of first visit
    empty
    بیماران به صورت یک در میان در یکی از گروه ها قرار میگیرند براساس زمان مراجعه و ویزیت اول
  • Secondary Ids

    #1
    ندارد
    empty
    ندارد
    empty
  • Recruitment centers

    #1
    Name of recruitment center - English: Imam khomeini hospital
    Name of recruitment center - Persian: مرکز آموزشی درمانی امام خمینی (ره)
    Full name of responsible person - English: professor gholamreza khtaminia
    Full name of responsible person - Persian: استاد دکتر غلامرضا خاتمی نیا
    Street address - English: ahvaz,24 metri street,imam khomeini hospital,eye ward
    Street address - Persian: اهواز .خیابان 24 متری(آزادگان).بیمارستان امام خمینی(ره).دفتر گروه چشم پزشکی.
    City - English: ahvaz
    City - Persian: اهواز
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Imam khomeini hospital
    Name of recruitment center - Persian: مرکز آموزشی درمانی امام خمینی (ره)
    Full name of responsible person - English: professor gholamreza khtaminia
    Full name of responsible person - Persian: استاد دکتر غلامرضا خاتمی نیا
    Street address - English: ahvaz,24 metri street,imam khomeini hospital,eye ward
    Street address - Persian: اهواز .خیابان 24 متری(آزادگان).بیمارستان امام خمینی(ره).دفتر گروه چشم پزشکی.
    City - English: ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 6193673111
    Phone: +98 61 3222 2818
    Fax:
    Email: khataminia@ajums.ac.ir
    Web page address:
  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Ahvaz Jondishapoor University of Medical Science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
    Full name of responsible person - English: dr behzad sharif makhmalzade,deputy of research and technology development
    Full name of responsible person - Persian: دکتر بهزاد شریف مخمل زاده معاونت محترم پژوهشی
    Street address - English: ahvaz,city universityوdeputy of research and technology development
    Street address - Persian: اهواز شهر دانشگاهی معاونت توسعه پژوهش و فناوری
    City - English: ahvaz
    City - Persian: اهواز
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: dr behzad sharif makhmalzade,deputy of research and technology development
    Full name of responsible person - Persian: دکتر بهزاد شریف مخمل زاده معاونت محترم پژوهشی
    Street address - English: ahvaz,city universityوdeputy of research and technology development
    Street address - Persian: اهواز شهر دانشگاهی معاونت توسعه پژوهش و فناوری
    City - English: ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Country: Iran (Islamic Republic of)
    Postal code: 6135715794
    Phone: +98 61 3336 2414
    Fax:
    Email: itc@ajums.ac.ir
    Web page address:
    empty
    Public
    empty
    Domestic
    empty
    Academic
    Ahvaz Jondishapoor University of Medical Science
    Ahvaz University of Medical Sciences
    دانشگاه علوم پزشکی جندی شاپور اهواز
    دانشگاه علوم پزشکی اهواز
  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Ahvaz Jondishapoor University of medical science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
    Full name of responsible person - English: mohammad saeed shakari
    Full name of responsible person - Persian: محمد سعید شکری
    Position - English: ophthalmology resident
    Position - Persian: رزیدنت چشم پزشکی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: ahvaz,24 metri street.imam khomeini hospital .eye ward
    Street address - Persian: اهواز خ 24متری،بیمارستان امام خمینی (ره)،بخش چشم پزشکی
    City - English: ahvaz
    City - Persian: اهواز
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 61 3222 8076
    Mobile: +98 918 842 1108
    Fax: +98 61 3222 8076
    Email: shakari.m@ajums.ac.irsaeed3131@gmail.com
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: mohammad saeed shakari
    Full name of responsible person - Persian: محمد سعید شکری
    Position - English: ophthalmology resident
    Position - Persian: رزیدنت چشم پزشکی
    Latest degree: med_doctor
    Area of specialty/work: 35
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: ahvaz,24 metri street.imam khomeini hospital .eye ward
    Street address - Persian: اهواز خ 24متری،بیمارستان امام خمینی (ره)،بخش چشم پزشکی
    City - English: ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6193673111
    Phone: +98 61 3222 8076
    Mobile: +98 918 842 1108
    Fax: +98 61 3222 8076
    Email: shakari.m@ajums.ac.ir
    Web page address:
  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Ahvaz Jondishapoor University of Medical Science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
    Full name of responsible person - English: dr gholamreza khataminia
    Full name of responsible person - Persian: دکتر غلامرضا خاتمی نیا
    Position - English: full professor oculoplastic and strabismus surgery
    Position - Persian: استاد تمام اکولوپلاستی و استرابیسم
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: ahvaz,24 metri street.imam khomeini hospital eye ward
    Street address - Persian: اهواز خ 24 متری بیمارستان امام خمینی (ره).بخش چشم پزشکی
    City - English: ahvaz
    City - Persian: اهواز
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 61 3222 8076
    Mobile: +98 916 111 0870
    Fax: +98 61 3222 8076
    Email: khataminia@hotmail.comkhataminia@ajums.ac.ir
    Web page address: http://fmedicine.ajums.ac.ir/HomePage.aspx?TabID=14720&Site=fmedicine.ajums.ac&Lang=fa-IR

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: dr gholamreza khataminia
    Full name of responsible person - Persian: دکتر غلامرضا خاتمی نیا
    Position - English: full professor oculoplastic and strabismus surgery
    Position - Persian: استاد تمام اکولوپلاستی و استرابیسم
    Latest degree: sub_specialist
    Area of specialty/work: 35
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: NO1,24 metri street.imam khomeini hospital eye ward,ahvaz
    Street address - Persian: اهواز خ 24 متری بیمارستان امام خمینی (ره).بخش چشم پزشکی
    City - English: ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6193673111
    Phone: +98 61 3222 8076
    Mobile: +98 916 111 0870
    Fax: +98 61 3222 8076
    Email: khataminia@ajums.ac.ir
    Web page address: http://fmedicine.ajums.ac.ir/HomePage.aspx?TabID=14720&Site=fmedicine.ajums.ac&Lang=fa-IR
  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Ahvaz jondishapoor University of medical science
    Name of organization / entity - Persian: دانشگاه علوم پزشکی جندی شاپور اهواز
    Full name of responsible person - English: mohammad saeed shakari
    Full name of responsible person - Persian: محمد سعید شکری
    Position - English: ophthalmology resident
    Position - Persian: رزیدنت چشم پزشکی
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ahvaz ,24 metri street ,imam khomeini hospital, eye ward
    Street address - Persian: اهواز خ 24 متری بیمارستان امام خمینی(ره)بخش چشم پزشکی
    City - English: ahvaz
    City - Persian: اهواز
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 61 3222 8076
    Mobile: +98 918 842 1108
    Fax: +98 61 3222 8076
    Email: saeed3131@gmail.comshakari.m@ajums.ac.ir
    Web page address:

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: mohammad saeed shakari
    Full name of responsible person - Persian: محمد سعید شکری
    Position - English: ophthalmology resident
    Position - Persian: رزیدنت چشم پزشکی
    Latest degree: med_doctor
    Area of specialty/work: 35
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: No1,24 metri street ,imam khomeini hospital, eye ward,ahvaz
    Street address - Persian: اهواز خ 24 متری بیمارستان امام خمینی(ره)بخش چشم پزشکی
    City - English: ahvaz
    City - Persian: اهواز
    Province: Khouzestan
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 6193673111
    Phone: +98 61 3222 8076
    Mobile: +98 918 842 1108
    Fax: +98 61 3222 8076
    Email: shakari.m@ajums.ac.ir
    Web page address:
  • Sharing plan

    no
    no
    no
    no
    yes
    no
    no
    empty
    no information
    empty
    اطلاعات بیشتری وجود ندارد
    empty
    results will be available in thesis
    empty
    نتایج پژوهش در قالب پایان نامه در دسترس خواهد بود
    empty
    since thesis was printed
    empty
    از زمان انتشار پایان نامه
    empty
    both scientific centers and faculty members
    empty
    هم محققین در مراکز علمی هم مراکز دانشگاهی
    empty
    as a refrence for other studies
    empty
    برای رفرنس دادن و استفاده از نتایج در مطالعات
    empty
    email:shakari.m@ajums.ac.ir
    empty
    ایمیل shakari.m@ajums.ac.ir
    empty
    monthy mail box will be checked
    empty
    ایمیل به طور ماهانه بررسی میشود

Protocol summary

Study aim
comparison between result of surgery on virgin muscles versus surgery on manipulated muscles in treatment of residual and consecutive esotropia and exotropia
Design
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,
Settings and conduct
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).
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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
Main outcome variables
Post operative deviation

General information

Reason for update
Acronym
IRCT registration information
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
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
2013-08-16, 1392/05/25
Actual recruitment end date
2017-10-23, 1396/08/01
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
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:
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
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 24
Actual sample size reached: 24
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
patients are distributed in groups one by one according to time of first visit
Placebo
Not used
Assignment
Single
Other design features
sampling is census

Secondary Ids

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
City
ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2017-07-22, 1396/04/31
Ethics committee reference number
IR.AJUMS.REC.1396.374

Health conditions studied

1

Description of health condition studied
esotropia,exotropia
ICD-10 code
H50.0,H50.
ICD-10 code description
Exotropia (alternating)(monocular), except intermittent,v

Primary outcomes

1

Description
horizontal deviation after surgery
Timepoint
before, 1 month ,three month later
Method of measurement
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
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2818
Email
khataminia@ajums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
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
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3336 2414
Email
itc@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
mohammad saeed shakari
Position
ophthalmology resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
ahvaz,24 metri street.imam khomeini hospital .eye ward
City
ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 8076
Fax
+98 61 3222 8076
Email
shakari.m@ajums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
dr gholamreza khataminia
Position
full professor oculoplastic and strabismus surgery
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
NO1,24 metri street.imam khomeini hospital eye ward,ahvaz
City
ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 8076
Fax
+98 61 3222 8076
Email
khataminia@ajums.ac.ir
Web page address
http://fmedicine.ajums.ac.ir/HomePage.aspx?TabID=14720&Site=fmedicine.ajums.ac&Lang=fa-IR

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
mohammad saeed shakari
Position
ophthalmology resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
No1,24 metri street ,imam khomeini hospital, eye ward,ahvaz
City
ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 8076
Fax
+98 61 3222 8076
Email
shakari.m@ajums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
no information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
results will be available in thesis
When the data will become available and for how long
since thesis was printed
To whom data/document is available
both scientific centers and faculty members
Under which criteria data/document could be used
as a refrence for other studies
From where data/document is obtainable
email:shakari.m@ajums.ac.ir
What processes are involved for a request to access data/document
monthy mail box will be checked
Comments
Loading...