Lateral Rectus Resection Versus Lateral Rectus Plication in Patients With Residual Esotropia
Primary Purpose
Strabismus
Status
Unknown status
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Lateral rectus plication
Lateral rectus Resection
Sponsored by
About this trial
This is an interventional treatment trial for Strabismus
Eligibility Criteria
Inclusion Criteria:
- residual esotropia after any strabismus surgery
Exclusion Criteria:
- Subjects with a history of prematurity
- lack of central fixation
- extraocular muscle palsy
- systemic disorders
- ocular disorders
- follow up less than three months
Sites / Locations
- Hamideh Sabbaghi
- Islamic Republic of Iran
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Plication
Resection
Arm Description
Outcomes
Primary Outcome Measures
Postoperative angle of deviation measured by alternative prism cover test based on prism diopter unit
Secondary Outcome Measures
Postoperative exodrift
Exodrift can be achieved by the change of the post- and preoperative angle of deviation measured by alternative prism cover test at far distance and recorded based on prism diopter unit.
Full Information
NCT ID
NCT04213768
First Posted
December 18, 2019
Last Updated
December 26, 2019
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT04213768
Brief Title
Lateral Rectus Resection Versus Lateral Rectus Plication in Patients With Residual Esotropia
Official Title
LR Resection Versus Plication in Esotropia
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 2019 (Anticipated)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
June 2020 (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
In this study, the surgical outcomes of lateral rectus plication and resection techniques on patients with residual esotropia will be compared.
Methods: In this randomized clinical trial, a total of 57 patients with residual esotropia (31 females and 26 males) who were candidate for lateral rectus resection are going to be included and randomized into plication and resection groups. The inclusion criteria will be residual esotropia after uni- or bilateral medial rectus recession, or unilateral recession and resection (R&R). Subjects with a history of prematurity, lack of central fixation, extraocular muscle palsy, systemic, ocular disorders, follow up less than three months will be excluded. A comprehensive ophthalmic examinations are going to be conducted preoperatively and at 1, 3 and 6 months' follow-ups. Surgical success rate will be considered in cases with a postoperative eso- or exotropia ≤10pd.
Detailed Description
In this clinical trial study, a total of 57 patients with residual esotropia (31 females and 26 males) who were candidate for lateral rectus resection will be included and randomized into plication (n=27) and resection (n=30) groups.
An informed consent will be obtained from all patients or their parents after explanation of the two techniques and their possible advantages and disadvantages. The study protocol will be approved by the Ethics Committee of Ophthalmic Research Center, Shahid Beheshti University of Medical Sciences, Tehran, Iran and it adheres to tenets of the Declaration of Helsinki.
The inclusion criteria will be the presence of residual esotropia ≥15pd after uni- or bilateral medial rectus recession. Subjects with a history of prematurity, intellectual disability, lack of central fixation (nystagmus, eccentric fixation, retinopathy of prematurity), extraocular muscle palsy, systemic, ocular, and neurological disorders, or follow- up less than three months will be excluded from this study. The surgeon who performed surgeries will not be masked, while the personnel who conducted data gathering and postoperative examinations will be blind to the group assignments.
Visual and Ocular Examinations Comprehensive ophthalmic examination including cyclorefraction (45 minutes after installation of one drop tropicamide 1% and cyclopentolate 1%), best corrected visual acuity (BCVA), extraocular muscle motility (version and duction from -4 to +4) will be performed, the ocular deviation will be measured at both far (6m) and near (33cm) distances using an alternate prism cover test or Krimsky method. A- or V- ocular pattern will be also determined if the difference of deviation was more than 10 or 15pd at 30 degrees between superior and inferior of primary position, respectively. Stereopsis will be measured using a Titmus test. According to the patients' response, stereopsis was also classified in to three groups of central (≤100 sec/arc), peripheral (100 to 3000 sec/arc) and suppression (≥3000). Ocular anterior and posterior segments will be examined using slit lamp and indirect ophthalmoscopy. Eligible patients will be randomly divided to lateral rectus plication (case) and lateral rectus resection (control) groups and the amount of operation will be according to the Park's table in the both groups. In patients with residual esotropia less than 20pd, unilateral lateral rectus recession and in patients with residual esotropia more than 20pd, bilateral lateral rectus recession will be considered. All examinations will be repeated at one, three and six month follow-ups. Surgical success rate will be considered in patients with a postoperative deviation ≤10pd.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Strabismus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
57 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Plication
Arm Type
Experimental
Arm Title
Resection
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Lateral rectus plication
Intervention Description
The technique is the same as resection up to the muscle suturing, in the next step, the sutures is passed through 2 scleral bites at 1 mm anterior to the muscle insertion, then the muscle is folded anteriorly by Stevens muscle hook during tightening and fixing the sutures. At the end, conjunctiva is repaired by Vicryl 8-0.
Intervention Type
Procedure
Intervention Name(s)
Lateral rectus Resection
Intervention Description
Following conjunctiva and tendon capsule incision, lateral rectus is hooked and dissected from its surrounding tissues. Then, the muscle is sutured according to the amount of supposed resection from lateral rectus insertion by Vicryl 6-0 (polyglation 910, coated Vicryl®, Ethicon, Blue Ash, OH). Afterwards, the muscle is cut at 1mm anterior to these sutures and the residual muscle is re-sutured to the sclera at its primary insertion. Finally the conjunctiva is repaired using Vicryl 8-0.
Primary Outcome Measure Information:
Title
Postoperative angle of deviation measured by alternative prism cover test based on prism diopter unit
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Postoperative exodrift
Description
Exodrift can be achieved by the change of the post- and preoperative angle of deviation measured by alternative prism cover test at far distance and recorded based on prism diopter unit.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
- residual esotropia after any strabismus surgery
Exclusion Criteria:
Subjects with a history of prematurity
lack of central fixation
extraocular muscle palsy
systemic disorders
ocular disorders
follow up less than three months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hamideh Sabbaghi, PhD
Phone
989120285930
Email
sabbaghi.opt@gmail.com
Facility Information:
Facility Name
Hamideh Sabbaghi
City
Tehran
Country
Iran, Islamic Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamideh Sabbaghi
Facility Name
Islamic Republic of Iran
City
Tehran
Country
Iran, Islamic Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hamideh Sabbaghi, MS
Phone
+989120285930
Email
sabbaghi_h@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Lateral Rectus Resection Versus Lateral Rectus Plication in Patients With Residual Esotropia
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