Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
25 participants
OBSERVATIONAL
2021-01-31
2023-05-01
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Interventions
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single minimal conjunctival incision
A 5-0 PGA traction suture was used near the corneal limbus corresponding to the operated muscle. A 3-4 mm single conjunctival incision posterior and parallel to the insertion in medial, lateral or superior rectus muscle was used. A hang-back recession of the muscle was done using 6-0 PGA suture. The conjunctiva was closed by an 8-0 PGA single stitch with knot burial
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
6 Years
60 Years
ALL
No
Sponsors
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Universidad Autonoma de Madrid
OTHER
Responsible Party
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Jaime Tejedor
Principal Investigator
Principal Investigators
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Jaime Tejedor, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Universite Abdou Moumouni de Niamey, Niger
Locations
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UAM
Madrid, , Spain
Countries
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Other Identifiers
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SMCI-22-0213
Identifier Type: -
Identifier Source: org_study_id
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