Clinical trial NCT05987878: Single Minimal Conjunctival Incision for Strabismus
Official title: Single Minimal Conjunctival Incision for Rectus Muscles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Strabismus, Comitant
Lead sponsor: Universidad Autonoma de Madrid
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25 subjects who required surgery of rectus muscle in comitant strabismus

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Duration of conjunctival swelling/hemorrhage
timeFrame: 2 months
Secondary outcomes:
measure: Motor outcome at 2 months after surgery (by Prism and Alternate Cover Test)
timeFrame: 2 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: UAM
Study officials:
affiliation: Universite Abdou Moumouni de Niamey, Niger
name: Jaime Tejedor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: