Single Minimal Conjunctival Incision for Strabismus

NCT05987878 | Completed DMC

• 1 other identifier: SMCI-22-0213
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Strabismus, Comitant

Outcome Measures

Primary Outcomes (1)

• Duration of conjunctival swelling/hemorrhage

  Evaluate duration of conjunctival swelling/hemorrhage

  2 months

Secondary Outcomes (1)

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

  2 months

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

Eligibility Criteria

• Age: 6 Years - 60 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

25 subjects who required surgery of rectus muscle in comitant strabismus

You may qualify if:

• patients requiring surgery of at least one rectus muscle with several diagnoses, operated under general or topical / sub-Tenon's anesthesia

You may not qualify if:

• patients had no previous eye muscle surgery

Sponsors & Collaborators

• Universidad Autonoma de Madrid: lead

Study Sites (1)

UAM

Madrid, 28029, Spain

Location

MeSH Terms

Conditions

Strabismus

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Officials

• Jaime Tejedor, MD, PhD

  Universite Abdou Moumouni de Niamey, Niger

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 26, 2023
• First Posted: August 14, 2023
• Study Start: January 31, 2021
• Primary Completion: March 1, 2023
• Study Completion: May 1, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

ES (1)