Extraocular Muscle Stretching as a Weakening Procedure

Strabismus, Comitant Clinical Trial

— EOMS  

Official title:

Stretching of an Extraocular Rectus Muscle as a Weakening Procedure

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05778565
• Other study ID #: OFTEOM-0322
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 13, 2021
• Est. completion date: June 23, 2023

Study information

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

Clinical Trial Summary

Interventional case series. Non-operated patients with an indication of medial rectus muscle weakening surgery (deviation up to 20 PD) who could cooperate with topical or sub-Tenon's anesthesia. Clinical workup includes routine complete ophthalmological evaluation. One double needle 6/0 Mersilene suture is used on each side of the muscle at 4 mm distance of the insertion and pulled / stretched to insert in the sclera 3-5 mm posterior to the muscle locking passes.

Seven patients with esotropia of 12-20 PD were included.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: June 23, 2023
• Est. primary completion date: June 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• Patients requiring weakening of medial rectus muscle(s) for 12-20 PD of esotropia who could cooperate with topical / sub-Tenon's anesthesia, and had no previous eye muscle surgery

Exclusion Criteria:

• Patients with previous strabismus surgery

Related Conditions & MeSH terms

• Strabismus
• Strabismus, Comitant

Intervention

Procedure:
• Extraocular muscle stretching
Extraocular muscle stretching to test its efficacy as a weakening procedure

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	Distance deviation at 2 months after surgery	Distance deviation at 2 months after surgery (alternate prim and cover)	2 months