Investigating the effect of inferior oblique muscle mycotomy along with superior rectus muscle reses with inferior oblique muscle mycotomy combined with upper rectus z-tenotomy by microsurgery (MICS) method on the amount of vertical deviation in patients with inferior oblique muscle hypertrophy more than 8-10 prism diopters : clinical trial
Comparison of the effect of combined surgery of inferior oblique muscle myectomy and superior rectus muscle recession with combined surgery of inferior oblique muscle myectomy and z_tenotomy using the upper right muscle MIS method in inferior oblique muscle hyperfunction more than 8-10 prism diopters
Design
Clinical trial with random permutation method, phase 3 on 60 patients, which was used for randomization using SPSS version 26 software.
Settings and conduct
After obtaining informed consent from the participants and after fully explaining the study to the patients at Imam Khomeini Hospital, it will be performed on patients with primary and secondary inferior oblique muscle hypertrophy whose primary position deviation is above 12 prism diopters. .
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients with primary and secondary inferior oblique muscle hyperfunction whose primary position deviation is above 12 prism diopters.
Exclusion criteria: People who had neurological and muscular diseases, patients who underwent eye surgery in the past, and also people who do not follow up regularly, will be excluded from the study.
Intervention groups
In the first group, lower oblique muscle mycotomy and upper rectus muscle recession, and for the second group, a combined surgery of lower oblique muscle mycotomy and z-tenotomy using the upper rectus muscle MIS method is performed in a minimally invasive way.
Main outcome variables
Degree of vertical deviation in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240121060751N1
Registration date:2024-02-02, 1402/11/13
Registration timing:prospective
Last update:2024-02-02, 1402/11/13
Update count:0
Registration date
2024-02-02, 1402/11/13
Registrant information
Name
Seyede mina Mousavi nezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 917 748 4498
Email address
mousavinezhad.m@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-02-07, 1402/11/18
Expected recruitment end date
2025-01-07, 1403/10/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of inferior oblique muscle mycotomy along with superior rectus muscle reses with inferior oblique muscle mycotomy combined with upper rectus z-tenotomy by microsurgery (MICS) method on the amount of vertical deviation in patients with inferior oblique muscle hypertrophy more than 8-10 prism diopters : clinical trial
Public title
Comparison of the effect of combined surgery of inferior oblique muscle myectomy and superior rectus muscle recession with combined surgery of muscle myectomy and inferior oblique muscle myectomy combined with z-tenotomy of superior rectus muscle by microsurgery method (MICS)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with primary and secondary inferior oblique muscle hypertrophy whose primary position deviation is above 10 prism diopters.
Exclusion criteria:
People who had neurological and muscular diseases, patients who underwent eye surgery in the past, and also people who do not follow up regularly, will be excluded from the study.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, patients will be divided into two groups using the random permutation method.
The method of assigning the intervention to patients is randomly and by the method of randomized permutation blocks with random block sizes of 4, 6 and 8 (using the table related to random permutations). The randomization list is prepared by a statistician. The intervention used in this research is allocated according to a randomized list.
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
Research Ethics Committee of Jundishapur University of Medical Sciences, Ahvaz
Street address
Jundishapur University of Medical Sciences، Koi Golestan، Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Approval date
2024-01-13, 1402/10/23
Ethics committee reference number
IR.AJUMS.REC.1402.546
Health conditions studied
1
Description of health condition studied
Mycotomy surgery of the inferior oblique muscle
ICD-10 code
H51.8
ICD-10 code description
Other specified disorders of binocular movement
Primary outcomes
1
Description
Degree of vertical deviation in patients
Timepoint
After the operation, it will be the first, third and seventh day and the third and sixth month. Orthopedic examinations applied before surgery will be repeated in the follow-ups and the results will be recorded. All patients will be operated by one surgeon.
Method of measurement
If there is, the amount of deviation through the prism cover test
Secondary outcomes
1
Description
visual acuity
Timepoint
After the operation, it will be the first, third and seventh day and the third and sixth month. Orthopedic examinations applied before surgery will be repeated in the follow-ups and the results will be recorded. All patients will be operated by one surgeon.
Method of measurement
Using Snellen's chart and on pre-school age patients, cooperation level will be measured by finger counting method.
Intervention groups
1
Description
Intervention group: The first group is lower oblique muscle myectomy and upper rectus muscle recession
Category
Treatment - Surgery
2
Description
For the second group, the combined surgery of inferior oblique muscle mycotomy with minimally invasive spinal surgery (MIS) of the superior rectus muscle is performed minimally.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Gholamreza Khataminia
Street address
24 metery street, east sahely highway, ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 111 0870
Email
khataminia@Hotmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mehrnoosh Zakerkish
Street address
University of medical science, Golestan street, Golestan town، Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 111 0870
Email
khataminia@Hotmail.com
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
Gholamreza Khataminia
Position
Professor of Ophthalmology
Latest degree
Specialist
Other areas of specialty/work
Ophthalmology
Street address
24 metery street, east sahely highway, ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 111 0870
Email
khataminia@Hotmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Gholamreza Khataminia
Position
Professor of Ophthalmology
Latest degree
Specialist
Other areas of specialty/work
Others
Street address
24 metery street, east sahely highway, ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 111 0870
Email
khataminia@Hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Gholamreza Khataminia
Position
Professor of Ophthalmology
Latest degree
Specialist
Other areas of specialty/work
Others
Street address
24 metery street, east sahely highway, ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
6193673166
Phone
+98 916 111 0870
Email
khataminia@Hotmail.com
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