Single Minimal Conjunctival Incision for Strabismus

Strabismus, Comitant Clinical Trial

Official title:

Single Minimal Conjunctival Incision for Rectus Muscles

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05987878
• Other study ID #: SMCI-22-0213
• Status: Completed
• Start date: January 31, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: August 2023
• Source: Universidad Autonoma de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 1, 2023
• Est. primary completion date: March 1, 2023
• Gender: All
• Age group: 6 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Strabismus
• Strabismus, Comitant

Intervention

Procedure:
• single minimal conjunctival incision
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

Locations

Country	Name	City	State
Spain	UAM	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Autonoma de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of conjunctival swelling/hemorrhage	Evaluate duration of conjunctival swelling/hemorrhage	2 months
Secondary	Motor outcome at 2 months after surgery (by Prism and Alternate Cover Test)	Evaluate motor status at 2 months after surgery	2 months