Postoperative deviations 45 days after surgery will measured by linear strabismometric method. The change in deviation (difference between preoperative and postoperative deviation at 45 days) will correlate to the surgical dose (dose–effect relationship) and the preoperative distance deviation by multiple regression analysis. Multivariate regression analysis will be performed with three and two independent variables (preoperative distance deviation, millimeters of advancement, intraoperative muscle stretch test), with change in deviation as a dependent variable.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201201128712N1
Registration date:2016-10-11, 1395/07/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-10-11, 1395/07/20
Registrant information
Name
Mojtaba Ziaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3725 6920
Email address
ziaee.m@srbiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Tabriz University of Medical Sciences .
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Dose- effect relationship of bilateral medial Rectus advancement in the treatment of consecutive exotropia
Public title
Effect of bilateral medical rectus advancement in the treatment of consecutive exotropia
Purpose
Treatment
Inclusion/Exclusion criteria
All patients had been previously operated for esotropia by surgeons.The operations for esotropia inferred on the
basis of the patient and family recollection and clinical examination (in particular, ocular motility and conjunctival scarring). Inclusion criteria: consecutive exotropia; limitation of adduction; convergence insufficiency and/or deviation greater at near than at distance and uni- or bilateral medial rectus muscle advancement. We will exclude patients who underwent simultaneous
medial rectus muscle advancement and lateral rectus muscle recession for consecutive exotropia, patients without adduction deficiency, and patients with an intraoperative finding of stretched scar.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
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
Tabriz University of Medical Sciences
Street address
Janbazan Sq. Daneshgah St.
City
Tabriz
Postal code
Approval date
2016-02-15, 1394/11/26
Ethics committee reference number
IR.TBXMED.REC.1394.1136
Health conditions studied
1
Description of health condition studied
Consecutive exotropia
ICD-10 code
H50.1
ICD-10 code description
Divergent concomitant strabismus
Primary outcomes
1
Description
MR advancement
Timepoint
45 days
Method of measurement
Observation
Secondary outcomes
1
Description
XT
Timepoint
45 days
Method of measurement
Observation
2
Description
ET
Timepoint
45 days
Method of measurement
Observation
Intervention groups
1
Description
Patients who undergo bilateral recess MR with CXT muscles and then placed under bilateral MR-adv corrective operations.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Nikoukari Hospital
Full name of responsible person
Dr. Reza Nabei
Street address
Nikoukari Eye Hospital
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Rashidi
Street address
Vice chancellor for Research
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Reza Nabie
Position
Associate Professor of Ophtalmology
Other areas of specialty/work
Street address
Nikoukari Eye Hospital
City
Tabriz
Postal code
Phone
+98 41 3657 7330
Fax
Email
r-nabie@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Reza Nabie
Position
Ophtalmologist
Other areas of specialty/work
Street address
Nikoukari Eye Hospital
City
Tabriz
Postal code
Phone
+98 41 3657 7330
Fax
Email
r-nabie@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Complex of Iranian Academic Center for Education, Culture and Research(ACECR)
Full name of responsible person
Mojtaba Ziaee
Position
Assistant Professor of Pharmacology
Other areas of specialty/work
Street address
Medicinal Plants Research Institute
City
Karaj
Postal code
Phone
Fax
Email
mjziaee@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)