Review and Comparison of Long-term Outcome of Intermittent Exotropia Surgery in Adults in Two Different Group with General Anesthesia and sedation with Local Anesthesia with Adjustment during surgery
1- Comparison of the mean of deviation before and week 1 and month 6 after X(T) surgery in the group with general anesthesia
2- Comparing the mean of deviation before and week 1 and month 6 after X(T) surgery in the group with local anesthesia
3- Comparison of the frequency of surgery result (Orthotropia/overcorrection/undercorrection) in two studied groups
Design
single-masked randomized controlled trial with Two arm parallel group. A total number of 50 patients divided into two equal groups using computerized randomization
Settings and conduct
Feiz Teaching Hospital, Isfahan, Iran؛Subjects were randomly assigned to one of the following groups: first group underwent muscle surgeries under General Anestesia(GA); second group underwent the same muscle surgeries plus adjustable sutures under local anesthesia and IV sedation
Participants/Inclusion and exclusion criteria
Inclusion criteria
Age over 18 years؛ Basic intermittent exotropia؛ below 60 prism diopters
Exclusion criteria
Neurological dificit؛ vertical muscle dysfunction؛ Patients with amblyopia؛ decreased visual acuity of any cause؛ history of strabismus or any other ocular surgery
Abnormal ophthalmologic exam
Intervention groups
first group underwent definite muscle surgery including either bilateral lateral rectus recession (BLRc) or single lateral rectus recession (LRc) under GA; second group underwent the same muscle surgeries plus adjustable sutures under local anesthesia and IV sedation.
Main outcome variables
_ Pre- Angle of Deviation
_ Post-Angle of Deviation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200502047271N1
Registration date:2022-09-20, 1401/06/29
Registration timing:registered_while_recruiting
Last update:2022-09-20, 1401/06/29
Update count:0
Registration date
2022-09-20, 1401/06/29
Registrant information
Name
Abolfazl Karimi Harandi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4650 7283
Email address
akarimiharandi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-23, 1401/06/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Review and Comparison of Long-term Outcome of Intermittent Exotropia Surgery in Adults in Two Different Group with General Anesthesia and sedation with Local Anesthesia with Adjustment during surgery
Public title
" Review of Long term Outcome of Intermittent Exotropia Surgery with General Anesthesia in Adults"؛"Review of Long term Outcome of Intermittent Exotropia Surgery with sedation and Local Anesthesia with Adjustment during surgery in Adults "
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Basic intermittent exotropia
below 60 prism diopters
Exclusion criteria:
Neurological dificit
vertical muscle dysfunction
Patients with amblyopia
decreased visual acuity of any cause
history of strabismus or any other ocular surgery
Abnormal ophthalmologic exam
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Block Randomization: A table with four columns and rows is prepared according to the number of patients, then people are placed in the houses of the table based on the toss of a coin, for this purpose, the Heads is assigned to the case group and the Tails is assigned to the control group. For example, if the coin toss is Heads-Tails, Heads-Tails, the four columns of the table are placed as case- control, case- control, and if the coin toss is Heads-Heads for the two patients, then for the next two patients There is no coin toss and they are placed in the control group and thus the number of samples is divided equally between the two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients are not aware of their allocation to the study groups, but were randomly assigned to one of the two study groups by the researcher. The operation of all patients is known to the surgeon and only the type of anesthesia differs based on randomization.
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
Alley 40, 3rd dead end, Modarres St, Ghods Sq
City
Esfahan
Province
Isfehan
Postal code
8134167594
Approval date
2020-05-11, 1399/02/22
Ethics committee reference number
IR.MUI.MED.REC.1399.136
Health conditions studied
1
Description of health condition studied
Intermittent exotropia
ICD-10 code
H50.34
ICD-10 code description
Intermittent alternating exotropia
Primary outcomes
1
Description
Angle of Deviation : Quantitative amount of exotropia based on prism measurement with prism diopter (PD)
Timepoint
Before surgery and one week and six months after surgery
Method of measurement
prism cover test
Secondary outcomes
empty
Intervention groups
1
Description
First Intervention group: underwent definite muscle surgery including bilateral lateral rectus recession (BLRc) under GA.GA was induced by administering a combination of propofol, succinylcholine,and sevoflurane.BLRc , a limbal approach was taken to create a triangular conjunctival flap that extended toward the lateral rectus (LR) muscle. The LR was delineated and caught by a muscle hook and secured by two 6-0 Vicryl sutures on the upper and lower borders of muscle tendon. A caliper was further used to mark the new insertion site, which was established on to the sclera.
Category
Treatment - Surgery
2
Description
Second Intervention group: underwent the same muscle surgeries under local anesthesia and IV sedation.Tetracaine 1% was used for topical anesthesia . On the other hand, IV sedation was induced by administering acombination of IV benzodiazepines, propofol, and ketamine, where necessary
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Feiz Teaching Hospital
Full name of responsible person
Abolfazl Karimi harandi
Street address
Quods Square, Modarres Street, Isfahan, Iran;
City
Esfahan
Province
Isfehan
Postal code
8149644875
Phone
+98 31 3445 2032
Email
akarimiharandi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansor siavash
Street address
Quods Square, Modarres Street, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8149644875
Phone
+98 31 3445 2032
Email
akarimiharandi@yahoo.com
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
Abolfazl Karimi harandi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Quods Square, Modarres Street, Isfahan, Iran;
City
Esfahan
Province
Isfehan
Postal code
8149644875
Phone
+98 31 3445 2032
Email
akarimiharandi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Abolfazl Karimi harandi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Quods Square, Modarres Street, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8149644875
Phone
+98 31 3445 2032
Email
akarimiharandi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Abolfazl Karimi harandi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Ophthalmology
Street address
Quods Square, Modarres Street, Isfahan, Iran
City
Esfahan
Province
Isfehan
Postal code
8149644875
Phone
+98 31 3445 2032
Email
akarimiharandi@yahoo.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