- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03768362
Comparison of Medial Rectus Resection and Plication in Exotropic Patients
Purpose: To determine the surgical outcomes of the plication technique in comparison with the resection method on exotropic patients.
Methods: In this randomized clinical trial, a total of 52 exotropic patients (female, 51.9%) who are candidate for medial rectus strengthening will be randomly classified into plication (n=24) and resection (n=28) groups. The comprehensive visual and ocular examinations will be performed on all study subjects and they will be followed- up for three months postoperatively. Plication technique is the same as resection up to muscle suturing, in the next step, the sutures are passed through 2 scleral bites at 1 mm anterior to the muscle insertion, then the muscle was folded toward inside or outside by pulling and joining the sutures.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Patients with a residual exotropia and history of uni- or bilateral lateral rectus recession or recession and resection (R &R) and those exotropic patients who were going to have already recession and resection (R & R) operation due to unilateral constant exotropia will be considered as eligible cases to be included.
Exclusion Criteria:
Subjects with a history of prematurity, intellectual disability, lack of central fixation (nystagmus, eccentric fixation, retinopathy of prematurity) subjects with systemic or other ocular diseases, neurological disorders, uncooperative patients and participants with less than three-month postoperative follow-up will be excluded from this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Undergoing plication strabismus surgery
|
The technique was the same as resection up to muscle suturing, in the next step, the sutures were passed through 2 scleral bites at 1 mm anterior to the muscle insertion, then the muscle was folded toward inside or outside by pulling and joining the sutures.
At the end, conjunctiva was repaired by vicryl 8/0.
|
Active Comparator: Undergoing resection strabismus surgery
|
resection strabismus surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative ocular deviation
Time Frame: three months
|
Postoperative ocular deviation will be measured at a distance of 6 meters three months after the surgery.
|
three months
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 13112
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Exotropia
-
Yonsei UniversityCompletedExotropia or Intermittent ExotropiaKorea, Republic of
-
Nunaps IncRecruitingIntermittent ExotropiaKorea, Republic of
-
Retina Foundation of the SouthwestRecruiting
-
Singapore National Eye CentreTerminatedIntermittent ExotropiaSingapore
-
Indiana University School of MedicineTerminatedIntermittent ExotropiaUnited States
-
Jaeb Center for Health ResearchNational Eye Institute (NEI); Pediatric Eye Disease Investigator GroupCompletedIntermittent ExotropiaUnited States
-
Samsung Medical CenterCompletedIntermittent Exotropia
-
Jaeb Center for Health ResearchNational Eye Institute (NEI); Pediatric Eye Disease Investigator GroupRecruitingIntermittent ExotropiaUnited States
-
Sun Yat-sen UniversitySalus UniversityNot yet recruitingIntermittent Exotropia
-
Southern California College of Optometry at Marshall...University of Alabama at Birmingham; Stanford University; Ohio State University; Case Western Reserve University and other collaboratorsRecruiting
Clinical Trials on Plication strabismus surgery
-
Minia UniversityCompleted
-
Tanta UniversityUnknown
-
Minia UniversityCompleted
-
The Cleveland ClinicRecruitingStrabismus | AmblyopiaUnited States
-
Hospital Universitario Ramon y CajalFundacion para la Investigacion Biomedica del Hospital Universitario Ramon...Unknown
-
Sun Yat-sen UniversityNot yet recruitingThyroid Associated OphthalmopathyChina