NCT05987878|CompletedDMC
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Sponsor study identifier
observational
25
1 country
1
Study Start
January 31, 2021
Actual (reported)Primary Completion
March 1, 2023
Actual (reported)Study Completion
May 1, 2023
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2023
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 31, 2021
Actual (reported)March 1, 2023
Actual (reported)May 1, 2023
Actual (reported)July 26, 2023
Actual (reported)August 14, 2023
Actual (reported)Duration of conjunctival swelling/hemorrhage
Evaluate duration of conjunctival swelling/hemorrhage
2 months
Motor outcome at 2 months after surgery (by Prism and Alternate Cover Test)
2 months
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
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25 subjects who required surgery of rectus muscle in comitant strabismus
UAM
Madrid, 28029, Spain
Jaime Tejedor, MD, PhD
Universite Abdou Moumouni de Niamey, Niger
25 participants (actual enrollment reported by the registry).
First Submitted
July 26, 2023
First Posted
August 14, 2023
Study Start
January 31, 2021
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
March 1, 2023
Actual (reported)Study Completion
May 1, 2023
Actual (reported)Last Updated
August 14, 2023
Record last verified: 2023-08
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Source: ClinicalTrials.gov.
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