Single Minimal Conjunctival Incision for Strabismus

NCT05987878 — Completed, 25 participants, Universidad Autonoma de Madrid

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Single Minimal Conjunctival Incision for Rectus Muscles

RegistryNCT05987878
StatusCompleted
Study typeObservational
Enrollment25 (Actual)
SponsorUniversidad Autonoma de Madrid (Other)
ConditionsStrabismus, Comitant
Interventionssingle minimal conjunctival incision (Procedure)
Datesstart 2021-01-31, primary completion 2023-03-01, completion 2023-05-01, first posted 2023-08-14, last updated 2023-08-14
Locations1 site in Spain

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All trials for Strabismus, Comitant All trials of single minimal conjunctival incision

-Summary

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.

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+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.

+Arms and interventions

  • single minimal conjunctival incision (Procedure): 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

+Outcome measures

Primary outcomes

  • Duration of conjunctival swelling/hemorrhage [2 months]: Evaluate duration of conjunctival swelling/hemorrhage

Secondary outcomes

  • Motor outcome at 2 months after surgery (by Prism and Alternate Cover Test) [2 months]: Evaluate motor status at 2 months after surgery

+Eligibility

Sex: All, ages: 6 Years to 60 Years

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

+Locations (1)

FacilityCityCountryStatus
UAMMadridSpain

+Investigators