An observational study in Strabismus, Comitant, sponsored by Universidad Autonoma de Madrid. Completed at 1 site in Spain. Open to participants aged 6 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-08-14.
Sponsored by Universidad Autonoma de Madrid · Observational
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.
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.
142 studies on the registry are indexed under Strabismus; 31 are open to participants now.
This study's enrollment of 25 is below the median of 96 across 54 observational studies indexed under Strabismus.
Browse Strabismus studies →Universidad Autonoma de Madrid is the lead sponsor of 51 studies on the registry; 7 are open to participants now.
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25 subjects who required surgery of rectus muscle in comitant strabismus
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Exclusion Criteria:
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
Duration of conjunctival swelling/hemorrhage
Evaluate duration of conjunctival swelling/hemorrhage
Time frame: 2 months
Motor outcome at 2 months after surgery (by Prism and Alternate Cover Test)
Evaluate motor status at 2 months after surgery
Time frame: 2 months
Plan to share: Undecided — Data shared when solicited to the PI
No publications or documents are linked to this record.
Ran from Jan 2021 to primary completion in Mar 2023, 25 months.
Of 26 observational studies under Strabismus, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 50. This study's 25 months is close to that.
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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Universidad Autonoma de Madrid