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Completed

NCT Number: NCT05987878

Single Minimal Conjunctival Incision for Strabismus

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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Key information

Conditions

Strabismus, Comitant Cranial Nerve Diseases Eye Diseases Nervous System Diseases Ocular Motility Disorders Strabismus

Age range

6 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UAM

Madrid, 28029, Spain

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Duration of conjunctival swelling/hemorrhage

    Time frame: 2 months

    Evaluate duration of conjunctival swelling/hemorrhage

Secondary outcomes

  1. Motor outcome at 2 months after surgery (by Prism and Alternate Cover Test)

    Time frame: 2 months

    Evaluate motor status at 2 months after surgery

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Madrid

Other

Registry information

Official study title

Single Minimal Conjunctival Incision for Rectus Muscles

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 14, 2023
Registry last updated
Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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