Back to resultsThe Effect of Slanted Recession of Horizontal Muscle on Horizontal Strabismus With Abnormal Accommodative Convergence /Accommodation Ratio (AC/A)
Primary Purpose
Horizontal Strabismus With High AC/A Ratio
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
conducting the slanted recession technique on the superior and inferior poles
conducting the augmented recession technique on the muscle
Sponsored by
About this trial
This is an interventional treatment trial for Horizontal Strabismus With High AC/A Ratio
Eligibility Criteria
Inclusion Criteria:
- all patients with horizontal strabismus that the different between far deviation and near deviation is more than 10 pd
Exclusion Criteria:
- all patients who had history of surgery on horizontal muscles and patients with pseudo high AC/A ratio.
Sites / Locations
- Ophthalmic Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
conducting the slanted recession technique
conducting the augmented recession technique on the muscle
Arm Description
conducting the slanted recession technique on the superior and inferior poles of the muscle based on far and near deviations.
conducting the augmented recession technique on the muscle for 1 to 1.50 mm more compared with the standard method.
Outcomes
Primary Outcome Measures
far-near deviation difference
difference between the far and near deviations
Secondary Outcome Measures
success rate of surgery
in cases with difference of far and near deviation less than 10 prism diopters
Full Information
NCT ID
NCT03555045
First Posted
April 11, 2018
Last Updated
June 12, 2018
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03555045
Brief Title
The Effect of Slanted Recession of Horizontal Muscle on Horizontal Strabismus With Abnormal Accommodative Convergence /Accommodation Ratio (AC/A)
Official Title
The Effect of Slanted Recession of Horizontal Muscle on Horizontal Strabismus With Abnormal Accommodative Convergence /Accommodation Ratio (AC/A)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
July 1, 2017 (Actual)
Study Completion Date
May 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Different methods was tried to treat high AC/A strabismus cases;such as prescription of bifocal glasses in esotropia,recession of horizontal muscles with posterior fixation sutures,more recession than needed for far deviation(augmented recession),recession and pulley fixation and slant recession.
Different results was reported for any type of above methods. In recent studies,slanted recession was applied for high AC/A in esotropic cases and success rate of 67% was reported.but there was no unanimity for procedure of choice.
Since slant recession method is simpler and has low side effect than the other methods,therefore in this study the investigators want to peruse the outcome of this method on high AC/A horizontal strabismus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Horizontal Strabismus With High AC/A Ratio
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conducting the slanted recession technique
Arm Type
Active Comparator
Arm Description
conducting the slanted recession technique on the superior and inferior poles of the muscle based on far and near deviations.
Arm Title
conducting the augmented recession technique on the muscle
Arm Type
Active Comparator
Arm Description
conducting the augmented recession technique on the muscle for 1 to 1.50 mm more compared with the standard method.
Intervention Type
Procedure
Intervention Name(s)
conducting the slanted recession technique on the superior and inferior poles
Intervention Description
conducting the slanted recession technique on the superior and inferior poles of the muscle based on far and near deviations.
Intervention Type
Procedure
Intervention Name(s)
conducting the augmented recession technique on the muscle
Intervention Description
conducting the augmented recession technique on the muscle for 1 to 1.50 mm more compared with the standard method.
Primary Outcome Measure Information:
Title
far-near deviation difference
Description
difference between the far and near deviations
Time Frame
90 days after surgery
Secondary Outcome Measure Information:
Title
success rate of surgery
Description
in cases with difference of far and near deviation less than 10 prism diopters
Time Frame
90 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
all patients with horizontal strabismus that the different between far deviation and near deviation is more than 10 pd
Exclusion Criteria:
all patients who had history of surgery on horizontal muscles and patients with pseudo high AC/A ratio.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
zhaleh rajavi, MD
Phone
9822591616
Email
labbafi@hotmail.com
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zhaleh Rajavi, MD
Phone
9822591616
Email
labbafi@hotmail.com
12. IPD Sharing Statement
Learn more about this trial
The Effect of Slanted Recession of Horizontal Muscle on Horizontal Strabismus With Abnormal Accommodative Convergence /Accommodation Ratio (AC/A)
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