To compare non absorbable and absorbable suture in patients with consecutive exotropia that undergo medial rectus muscle advancement.
Design
Two arm parallel group randomised and single blinded trial with blind postoperative care and outcome assessment
Settings and conduct
This study is conducted at Farabi Eye Hospital- Tehran University of Medical Sciences. The person, who will measure preoperative and postoperative angle of deviation will be kept blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Angle of consecutive exotropia more than 15 prism diopter; Consecutive exotropia cases that need single medial rectus advancement. Exclusion criteria:
History of neurologic problems; Significant vertical deviation; Less than 4 months passed from previous surgery.
Intervention groups
In group 1 (case ) medial rectus muscle advancement using non absorbable suture is applied.
In group 2 (control ) medial rectus muscle advancement using absorbable suture is considered.
Main outcome variables
Deviation, XT or ET
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190502043449N1
Registration date:2019-05-27, 1398/03/06
Registration timing:prospective
Last update:2019-05-27, 1398/03/06
Update count:0
Registration date
2019-05-27, 1398/03/06
Registrant information
Name
Amirreza Veisi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5542 6283
Email address
amirveisi3@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-10-23, 1398/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing Medial rectus Advancement Using Non absorbable versus Absorbable Suture in patients with Consecutive Exotropia
Public title
Consecutive exotropia treatment
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Consecutive exotropia following medial rectus recession
consecutive exotropia > 15 PD
consecutive exotropia cases that need single medial rectus advancement
Exclusion criteria:
History of neurologic problems
Significant vertical deviation
Less than 4 M passed from previous surgery
Positive forced duction test
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Method of randomization is permuted block randomization. The blocks of size 2, 4 and 6 will be used.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is single blinded. The person who assesses outcomes will be kept blind.
Placebo
Not used
Assignment
Parallel
Other design features
no
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Farabi Eye Hospital, Tehran University of Medical Sciences
Street address
Ghazvin square, South Kargar street
City
Tehran
Province
Tehran
Postal code
1336516351
Approval date
2019-04-13, 1398/01/24
Ethics committee reference number
IR.TUMS.FARABIH.REC.1398.004
Health conditions studied
1
Description of health condition studied
Consecutive exotropia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
postoperative angle of deviation
Timepoint
3 months and 6 months
Method of measurement
Prism
Secondary outcomes
1
Description
recurrence of angle of deviation
Timepoint
Before surgery, 1 week, 3 months and 6 months after surgery