Single Minimal Conjunctival Incision for Strabismus

Completed

• Conditions: Strabismus, Comitant

• Registration Number: NCT05987878
• Lead Sponsor: Universidad Autonoma de Madrid

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.

Study Timeline

• Study Start: 2021-01-31
• Primary Completion: 2023-03-01
• Study Completion: 2023-05-01
• Study First Submitted: 2023-07-26
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-03
• Last Update Submitted: 2023-08-03
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of conjunctival swelling/hemorrhage	2 months	Evaluate duration of conjunctival swelling/hemorrhage

Secondary Outcome Measures

Name	Time	Method
Motor outcome at 2 months after surgery (by Prism and Alternate Cover Test)	2 months	Evaluate motor status at 2 months after surgery

Trial Locations

Locations (1)

UAM; 🇪🇸 Madrid, Spain