The effect of horizontal rectus muscle weakening by lateral rectus muscle marginal myotomy with medial rectus muscle recession in palpebral fissure height in duane retraction syndrome type1
The effect of horizontal rectus muscle weakening by lateral rectus muscle marginal myotomy with medial rectus muscle recession in palpebral fissure height in duane retraction syndrome type1
Design
Clinical trials with control group, with parallel groups, randomized
Settings and conduct
Twenty-eight patients referred to the Fifth Grade Strabism Center with type 1 Duane syndrome who needed rectus weakening surgery were selected easily and in a convenient way and then completely randomly assigned to two groups of 14 subjects. Surgery, 2 weeks and 3 months after surgery, the degree of deflection of the eye in the face position, the vertical deflection of the affected eye in front of the eye, and the extent of the narrowing of the affected eye eyelid with a view to the opposite side of the measurement Became Also abnormal head rotation was recorded based on the opinion of the physician and the parents of the patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Detection of Type 1 Disease Syndrome Based on Diagnostic Criteria
Age of the patient is 5 years or more
The amount of distortion in the eye is less than 20 prisma diopters.
The need for horizontal rectus muscle weakening
Patient Satisfaction to Participate in the Study.
Exclusion criteria:
History of strabismus surgery
There is an abnormal edge of the eyelid
The presence of simultaneous neurological and chromosomal problems
Other synchronous eye pathologies
Intervention groups
In the intervention group, the surgical intervention was performed in the form of a medial rectus withdrawal with marginal myometrium and in the surgical control group as a medullar rectus resection alone.
Main outcome variables
Distraction of the affected eye in front of the eye; Vertigo of the affected eye in front of the eye; narrowing of the affected eye lid gap in front of the eye; Abnormal head swing.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131229015975N3
Registration date:2019-03-27, 1398/01/07
Registration timing:retrospective
Last update:2019-03-27, 1398/01/07
Update count:0
Registration date
2019-03-27, 1398/01/07
Registrant information
Name
Mohsen Pourazizi
Name of organization / entity
Semnan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 23 1445 1385
Email address
m.pourazizi@sem-ums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
2017-06-22, 1396/04/01
Actual recruitment end date
2018-02-19, 1396/11/30
Trial completion date
2018-02-19, 1396/11/30
Scientific title
The effect of horizontal rectus muscle weakening by lateral rectus muscle marginal myotomy with medial rectus muscle recession in palpebral fissure height in duane retraction syndrome type1
Public title
The effect of horizontal rectus muscle weakening by lateral rectus muscle marginal myotomy with medial rectus muscle recession in palpebral fissure height in duane retraction syndrome type1
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Type 1 Doyen syndrome based on diagnostic criteria: Restrictions on the horizontal movements of the eye, especially in abduction, eye drooping and eyedropic narrowing during up / down shoot of the eye during adduction.
Age of the patient is 5 years or more
The patient's age is 5 years or more.
The amount of distortion in the eye is less than 20 prisma diopters.
Need to weaken horizontal rectus muscles based on the diagnosis of an ophthalmologist
Patient Satisfaction to Participate in the Study
Exclusion criteria:
History of strabismus surgery
There is an abnormal edge of the eyelid
The presence of simultaneous neurological and chromosomal problems
Other synchronous eye pathologies
Age
From 5 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
28
Actual sample size reached:
28
Randomization (investigator's opinion)
Randomized
Randomization description
The selection of patients was easy and accessible among patients with type 1 duine syndrome referring to Feyz Hospital in Isfahan, which has acceptable criteria. The patients were randomly assigned to two groups based on chance chances. In the operating room, envelopes containing recession paper and myotomy were placed in front of the patient and the patient entered one of the intervention groups by selecting one of the envelopes....
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2017-05-31, 1396/03/10
Ethics committee reference number
396503
Health conditions studied
1
Description of health condition studied
Duane syndrome type1
ICD-10 code
H01.9
ICD-10 code description
Inflammation of eyelid, unspecified
Primary outcomes
1
Description
The degree of deviation of the affected eye is in the face
Timepoint
Before surgery, two weeks and three months after surgery.
Method of measurement
Clinical examination by the same surgeon.
2
Description
Vertical deviation of the affected eye in front of the eye
Timepoint
Before surgery, two weeks and three months after surgery.
Method of measurement
Clinical examination by the same surgeon.
3
Description
The amount of narrowing of the affected eye lid in front of the eye
Timepoint
Before surgery, two weeks and three months after surgery.
Method of measurement
Clinical examination by the same surgeon.
4
Description
Abnormal head rotation
Timepoint
Before surgery, two weeks and three months after surgery.
Method of measurement
Clinical examination by the same surgeon and patient report or his parents.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 14 patients diagnosed with ophthalmologist diagnosed with duine type 1 syndrome were selected to resolve the problem of eyelid narrowing, medial rectus medial intervention with marginal micectomy, and face-to-face factors (primary position), the vertical deviation of the affected eye in front of the eye, the degree of narrowing of the affected eyelid gap in front of the eye, and abnormal spinal rotation before, two weeks and three months after surgery, and it is registered.
Category
Treatment - Surgery
2
Description
Control group: 14 patients diagnosed with ophthalmologic diagnosis of type 1 duine syndrome were diagnosed and treated for rectus medication, and interventional rectus medication was used for solving the problem of eyelid narrowing. Primary position), the vertical deviation of the affected eye in front of the eye, the degree of narrowing of the affected eyelid gap in front of the eye and abnormal spinal rotation were measured and recorded before, two weeks and 3 months after surgery. .
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz Hospital in Isfahan
Full name of responsible person
Alireza Zandi
Street address
Quds Squ.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
dr_zandi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Mohsen Pourazizi
Position
M.D.
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
m.pourazizi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Alireza Zandi
Position
Associate Professor
Latest degree
Subspecialist
Other areas of specialty/work
Ophthalmology
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
dr_zandi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Arman Amirkhani
Position
M.D.
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Isfahan University of Medical Sciences, Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
dr_zandi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Individual data of the participants can be made available to applicants after being unidentifiable and two years after the publication of the results.
When the data will become available and for how long
Two years after the publication of the results
To whom data/document is available
Specialists and assistants of the Eye Surgery Group.
Under which criteria data/document could be used
To compare the same method with the proposed method in this study
From where data/document is obtainable
Send a clear request to dr_zandi@yahoo.com and with the permission of the research and student deputy of the Isfahan University of Medical Sciences.
What processes are involved for a request to access data/document
Send a clear request to dr_zandi@yahoo.com and with the permission of the research and student deputy of the Isfahan University of Medical Sciences.