surgical result of horizontal rectus muscle elongation on large-angle strabismus
Design
The intervention is performed on patients older than four years and large-angle horizontal strabismus (ET ≥ 50PD, XT ≥ 60PD) who had no history of strabismus surgery and whose deviation was not paretic or restrictive. These patients undergo muscle elongation surgery instead of conventional recession if indicated. Depending on the degree of deviation, this procedure is performed bilaterally or with resection of the antagonist muscle on the same side.
Settings and conduct
Interventional case series study on patients with large-angle horizontal strabismus (ET ≥ 50PD, XT ≥ 60PD) who undergo surgery within the next year (at least 5 patients). These patients undergo rectus muscle elongation surgery instead of conventional recession if indicated. Depending on the degree of deviation, this procedure is performed bilaterally or with resection of the antagonist muscle on the same side.
Participants/Inclusion and exclusion criteria
Age ≥ 4 years
large-angle strabismus (ET ≥50PD, XT≥60PD)
Concomitant strabismus
Intervention groups
Horizontal rectus muscle elongation surgery on large-angle Horizontal strabismus
Main outcome variables
Correction rate of ocular deviation 2 weeks, 2 months, 6 months after surgery
Correction rate of deviation relative to elongation rate, two weeks, 2 months, 6 months postoperatively
Degree of restricted eye movements after surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220220054077N1
Registration date:2022-05-28, 1401/03/07
Registration timing:prospective
Last update:2022-05-28, 1401/03/07
Update count:0
Registration date
2022-05-28, 1401/03/07
Registrant information
Name
ali norouzi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3728 1400
Email address
dr.alinoroozi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-06-05, 1401/03/15
Expected recruitment end date
2022-09-06, 1401/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of surgical result of horizontal rectus muscle elongation on large-angle strabismus in patients older than 4 years
Public title
Surgical result of horizontal rectus muscle elongation on large-angle strabismus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with large-angle strabismus (ET ≥50PD, XT≥60PD)
Concomitant strabismus
Age ≥ 4 years
Exclusion criteria:
Paretic or restrictive strabismus
History of strabismus surgery
Age
From 4 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
13
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
Faculty of Medicine, Mashhad University of Medical Sciences
Street address
East door of the university campus, Azadi Square, Mashhad, Khorasan Razavi
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Approval date
2022-02-07, 1400/11/18
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1400.732
Health conditions studied
1
Description of health condition studied
large-angle exotropia
ICD-10 code
H501
ICD-10 code description
Exotropia (from Greek exo meaning "outward" and trope meaning "a turning"), also referred to as divergent squint, is a form of strabismus where the eyes are deviated outward. It is the opposite of esotropia. People with exotropia often experience crossed
2
Description of health condition studied
large-angle esotropia
ICD-10 code
H500
ICD-10 code description
Esotropia (from Greek eso meaning "inward" and trope meaning "a turning"), is a form of strabismus, or "squint," in which one or both eyes turns inward. The condition can be constantly present, or occur intermittently, and can give the affected individual
Primary outcomes
1
Description
Angle of deviation
Timepoint
2 weeks, 2 months, 6 months after surgery
Method of measurement
Krimsky, modified Krimsky, Hirschberg, Alternate cover test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The width of the muscle is divided into 3 equal parts, one upper and lower third after sewing with 6-0 vicryl thread is cut from the insertion site and the middle part is cut to the end, which determines the amount of engagement according to the preoperative prediction. It is desired to be sewn. This procedure is performed bilaterally or with antagonist muscle resection on the same side. The choice of one-sided or two-sided operation will be based on the usual criteria. Alternate deviations or cases where the exotropia in far or the esotropia in near are more, preferably with bilateral surgery, and in cases of constant unilateral deviation, surgery will be performed on one eye.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Khatam Ol-Anbia Eye Hospital
Full name of responsible person
Ali Akbar Sabermoghadam
Street address
Shahid Gharani Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Fax
+98 51 3724 5363
Email
kh.pr@mums.ac.ir
Web page address
https://khatam.mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Shahid Fakouri Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
91778-99191
Phone
+98 51 3841 2081
Fax
+98 51 3871 3638
Email
Info.en@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Aliakbar Saber Moghaddam Ranjbar
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Shahid Gharani Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Email
SaberAA@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Aliakbar Saber Moghaddam Ranjbar
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Shahid Gharani Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Email
SaberAA@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Aliakbar Saber Moghaddam Ranjbar
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Shahid Gharani Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9195965919
Phone
+98 51 3728 1401
Email
SaberAA@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available