- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05987878
Single Minimal Conjunctival Incision for Strabismus
Single Minimal Conjunctival Incision for Rectus Muscles
The purpose of this investigation is to study the feasibility and inflammatory response of surgery for rectus muscles using a small single bulbar conjunctival incision posterior and parallel to the muscle insertion.
Patients requiring surgery of at least one rectus muscle with several diagnoses, operated under general or topical / sub-Tenon's anesthesia, who had no previous eye muscle surgery, will be recruited. Routinary clinical ophthalmological examination will be carried out. After applying a 5-0 PGA traction suture, a 3-4 mm single conjunctival incision posterior and parallel to the rectus muscle insertion will be done. A hang-back recession with 6-0 PGA suture will be carried out, and the conjunctiva closed by an 8-0 PGA single stitch. The main outcome measure will be duration of swelling and hemorrhage, and secondary outcome measure will be motor outcome at 2 months after surgery.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Purpose/Background: To study the feasibility and inflammatory response of surgery for rectus muscles using a small single bulbar conjunctival incision posterior and parallel to the muscle insertion.
Methods: Patients requiring surgery of at least one rectus muscle with several diagnoses, operated under general or topical / sub-Tenon's anesthesia, who had no previous eye muscle surgery, are included. Routinary clinical ophthalmological examination is carried out. After applying a 5-0 PGA traction suture, a 3-4 mm single conjunctival incision posterior and parallel to the rectus muscle insertion will be done. A hang-back recession with 6-0 PGA suture will be carried out, and the conjunctiva closed by an 8-0 PGA single stitch. The main outcome measure is duration of swelling and hemorrhage, and secondary outcome measure is motor outcome at 2 months after surgery. Results are compared with retrospectively collected data of patients operated using limbal (n= 20) and fornix incision (n= 21) as a point of reference.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Madrid, Spain, 28029
- UAM
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients requiring surgery of at least one rectus muscle with several diagnoses, operated under general or topical / sub-Tenon's anesthesia
Exclusion Criteria:
- patients had no previous eye muscle surgery
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of conjunctival swelling/hemorrhage
Time Frame: 2 months
|
Evaluate duration of conjunctival swelling/hemorrhage
|
2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Motor outcome at 2 months after surgery (by Prism and Alternate Cover Test)
Time Frame: 2 months
|
Evaluate motor status at 2 months after surgery
|
2 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jaime Tejedor, MD, PhD, UAM
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
- SMCI-22-0213
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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 Strabismus, Comitant
-
Universidad Autonoma de MadridActive, not recruiting
-
University of MiamiCompletedSuture Strabismus SurgeryUnited States
-
Assiut UniversityNot yet recruitingLarge Angle Horizontal StrabismusEgypt
-
South Valley UniversityEnrolling by invitation
-
Minia UniversityCompleted
-
Shahid Beheshti University of Medical SciencesUnknownHorizontal Strabismus With High AC/A RatioIran, Islamic Republic of
-
Sun Yat-sen UniversityRecruitingStrabismus | Exotropia | Esotropia | Vertical StrabismusChina
-
Tanta UniversityCompletedSurgical Procedure, Unspecified | Ocular Discomfort | Strabismus, Divergent
Clinical Trials on single minimal conjunctival incision
-
Michigan Institution of Women's Health PCActive, not recruitingStress Urinary IncontinenceUnited States
-
University of Texas Southwestern Medical CenterCompleted
-
Western Galilee Hospital-NahariyaCompletedPost Operative Complications | Intra-operative ComplicationsIsrael
-
Maltepe UniversityCompletedStress Urinary IncontinenceTurkey
-
Coloplast A/SActive, not recruitingUrinary Incontinence, StressSpain, Belgium, France, Germany, Italy
-
Hvidovre University HospitalCompletedAdenocarcinoma | Rectal CancerDenmark
-
University of British ColumbiaCompleted
-
University of California, San DiegoCompletedAppendicitis | Cholelithiasis | Malignant HypertensionUnited States
-
C. R. BardCompletedFemale Stress Urinary IncontinenceUnited States
-
Coloplast A/SCompletedStress Urinary IncontinenceSpain, France, Italy, Germany, Netherlands