Back to resultsEarly Results of Slanted Recession of the Lateral Rectus Muscle for Intermittent Exotropia With Convergence Weakness
Primary Purpose
Intermittent Exotropia
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Slanted recession of the lateral rectus muscle
Sponsored by
About this trial
This is an interventional treatment trial for Intermittent Exotropia
Eligibility Criteria
Inclusion Criteria:
- Patients with intermittent exotropia greater at near than at distance by 10 prism diopters or more
- Patients with follow up duration greater than 6 months
Exclusion Criteria:
- Patients with previous ocular or strabismus surgery
- Patients with ocular or neurologic pathologic conditions
- Follow up duration less than 6 months
Sites / Locations
- Bo Young Chun
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Lateral Rectus Muscle Slanted Recession
Arm Description
Slanted recession of the lateral rectus muscle for the intermittent exotropia with convergence weakness
Outcomes
Primary Outcome Measures
Changes from baseline of exodeviations angle after slanted recession surgery at 6 months.
Measurement of deviation angle after slanted recession surgery was performed.
Secondary Outcome Measures
Changes from baseline of near-distance difference after slanted recession surgery at 6 months
Measurement of stereopsis after slanted recession was performed.
Full Information
NCT ID
NCT02131792
First Posted
May 4, 2014
Last Updated
May 4, 2014
Sponsor
Kyungpook National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02131792
Brief Title
Early Results of Slanted Recession of the Lateral Rectus Muscle for Intermittent Exotropia With Convergence Weakness
Official Title
Early Results of Slanted Recession of the Lateral Rectus Muscle for Intermittent Exotropia With Convergence Weakness; A Prospective Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyungpook National University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study was conducted to evaluate results of slanted recession of the lateral rectus muscle for intermittent exotropia with convergence weakness
Detailed Description
This prospective study included 31 patients who underwent slanted lateral rectus muscle recession for intermittent exotropia with convergence weakness. Measurements of preoperative and postoperative deviation angle, stereopsis was performed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intermittent Exotropia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lateral Rectus Muscle Slanted Recession
Arm Type
Experimental
Arm Description
Slanted recession of the lateral rectus muscle for the intermittent exotropia with convergence weakness
Intervention Type
Procedure
Intervention Name(s)
Slanted recession of the lateral rectus muscle
Intervention Description
All patients who had intermittent exotropia with convergence weakness was enrolled to the slanted lateral rectus muscle recession group.
Primary Outcome Measure Information:
Title
Changes from baseline of exodeviations angle after slanted recession surgery at 6 months.
Description
Measurement of deviation angle after slanted recession surgery was performed.
Time Frame
preop, 6months postop
Secondary Outcome Measure Information:
Title
Changes from baseline of near-distance difference after slanted recession surgery at 6 months
Description
Measurement of stereopsis after slanted recession was performed.
Time Frame
preop, 6 months postop
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with intermittent exotropia greater at near than at distance by 10 prism diopters or more
Patients with follow up duration greater than 6 months
Exclusion Criteria:
Patients with previous ocular or strabismus surgery
Patients with ocular or neurologic pathologic conditions
Follow up duration less than 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bo Young Chun, M.D
Organizational Affiliation
Kyungpook National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bo Young Chun
City
Daegu
State/Province
Kyungsangpookdo
ZIP/Postal Code
700-721
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Early Results of Slanted Recession of the Lateral Rectus Muscle for Intermittent Exotropia With Convergence Weakness
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