evaluation of the effect size of extraocular myofascial release technique on the angle of deviation in non-accommodative Eso deviations
Design
A self-controlled clinical trial, single-arm, phase 2-3
Settings and conduct
Patients with non-accommodative Eso deviation due to convergence spasm remain without treatment intervention for a week after measuring the deviation near and far. At the end of the no-treatment week, the angle of deviation and the saccades' velocity will be measured. Then, the treatment intervention (extraocular myofascial release technique) is performed in two stages during one week for both eyes. At the end of this week, the angle of deviation and the saccades' velocity will be measured again, and their results will be compared.
Study location: Optometry Clinic, School of Rehabilitation, Iran University of Medical Sciences
Participants/Inclusion and exclusion criteria
Participants: Young people with convergence spasm
Inclusion criteria:
Age: 20 to 35 years
Cyclofraction less than +1.00 D
Visual acuity of 20/20 or better with correction
Esophoria or Esotropia at near or far after complete refractive correction
Normal AC/A ratio (2.86±2.40) (Mean ± SD)
Comitancy of the deviation angle
The occurrence of deviation or related symptoms in less than one year
Exclusion criteria:
Use of any drug affecting the central nervous system
Any underlying disease and drug usage
History of the head or eye trauma
History of strabismus surgery
Intervention groups
Patients with non-accommodative Eso deviation due to convergence spasm remain without therapeutic intervention for a week (control). Then the therapeutic intervention (releasing myofascial tissue for the medial rectus and related connective tissue for at least 300 seconds for each eye) is performed in two stages during the following week (intervention).
Main outcome variables
The magnitude of Eso deviation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210130050183N1
Registration date:2021-02-15, 1399/11/27
Registration timing:prospective
Last update:2021-02-15, 1399/11/27
Update count:0
Registration date
2021-02-15, 1399/11/27
Registrant information
Name
Alireza Mohamadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2227 8565
Email address
alremone@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-19, 1399/12/01
Expected recruitment end date
2021-04-21, 1400/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the efficacy of extraocular myofascial technique on non-accommodative Eso deviations
Public title
Effect of extraocular myofascial technique in treatment of strabismus
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Less than +1.00 D cyclo-refraction
Corrected visual acuity of 20/20 or better
Esophoria or Esotropia at far or near after complete refractive correction
Normal gradient AC/A ratio (2.86±2.40) (Mean ± SD)
Comitancy in angle of deviation
Recent onset of the deviation or its symptoms (less than one year ago)
Exclusion criteria:
Improper use of spectacle glasses (if the subject has a refractive error)
Use of any drug affecting the central nervous system during study period
Any underlying disease and drug usage
History of the head or eye trauma
History of strabismus surgery
Suffering COVID-19 or any symptoms of the disease
Age
From 20 years old to 35 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
12
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
Ethics committee of Iran University of Medical Sciences
Street address
Fifth Floor, Headquarters, Iran University of Medical Sciences, Hemmat Highway between Chamran and Sheikh Fazlollah
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Approval date
2021-02-13, 1399/11/25
Ethics committee reference number
IR.IUMS.REC.1399.1241
Health conditions studied
1
Description of health condition studied
Non-accommodative Esotropia due to spasm of convergence
ICD-10 code
H50.0
ICD-10 code description
Convergent concomitant strabismus
2
Description of health condition studied
Non-accommodative Esophoria due to spasm of convergence
ICD-10 code
H50.5
ICD-10 code description
Heterophoria
Primary outcomes
1
Description
Magnitude of the Eso deviation
Timepoint
At the initial visit - after one week without treatment - after one week of therapeutic intervention
Method of measurement
Cover-test and Prism bar
Secondary outcomes
1
Description
Saccadic Movement Velocity
Timepoint
After one week without treatment - after one week of therapeutic intervention
Method of measurement
Dynamic Electrooculography
Intervention groups
1
Description
Intervention group: In the first week, we will have no treatment; then, the therapeutic intervention will be done. It includes the myofascial release technique for the medial rectus muscle and its related connective tissue for at least 300 seconds per eye twice in a week for both eyes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor eye hospital
Full name of responsible person
Alireza Mohamadi
Street address
No. 96, Esfandiar Blvd, Valiasr St.
City
Tehran
Province
Tehran
Postal code
1968653111
Phone
+98 21 8240 1670
Email
alremone@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Syed Abbas Motevallian
Street address
The fifth floor of the headquarters Iran University of Medical Sciences, Hemmat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2503
Email
research-m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Alireza Mohamadi
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Optometry
Street address
Unit 1 east, Floor 1, No. 4, 10th St., North Dr. Mosaddegh (Naft) St., Dastgerdi (Zafar) Ave., District 3
City
Tehran
Province
Tehran
Postal code
1918797814
Phone
+98 21 2227 8565
Email
alremone@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Ebrahim Jafarzadehpour
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Optometry
Street address
School of Optometry, Faculty of Rehabilitation Sciences, Iran University of Medical Sciences Maddakaran St., Shah Nazari St., Madar Square, Mirdamad Ave.
City
Tehran
Province
Tehran
Postal code
1545913487
Phone
+98 21 2222 7124
Email
jafarzadehpour.e@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Alireza Mohamadi
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Optometry
Street address
Unit 1 east, Floor 1, No. 4, 10th St., North Dr. Mosaddegh (Naft) St., Dastgerdi (Zafar) Ave., District 3
City
Tehran
Province
Tehran
Postal code
1918797814
Phone
+98 21 2227 8565
Email
alremone@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
After de-identifying the IPD will be shared.
When the data will become available and for how long
Access starts two years after the results are published
To whom data/document is available
All
Under which criteria data/document could be used
0
From where data/document is obtainable
0
What processes are involved for a request to access data/document