Extraocular Muscle Stretching as a Weakening Procedure

Not Applicable

Active, not recruiting

• Conditions: Strabismus, Comitant

• Registration Number: NCT05778565
• Lead Sponsor: Universidad Autonoma de Madrid

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-13
• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-03-09
• Study First Posted: 2023-03-21
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-02
• Last Update Posted: 2023-05-03
• Primary Completion: 2023-06-23
• Study Completion: 2023-06-23

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

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

Trial Locations

Locations (1)

UAM; 🇪🇸 Madrid, Spain