EOMS: Extraocular Muscle Stretching as a Weakening Procedure

Sponsor

Universidad Autonoma de Madrid (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05778565

Collaborator

(none)

Enrollment

Location

Arm

26.3

Anticipated Duration (Months)

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Strabismus, Comitant	Procedure: Extraocular muscle stretching	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

7 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Extraocular muscle procedureExtraocular muscle procedure

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Stretching of an Extraocular Rectus Muscle as a Weakening Procedure

Actual Study Start Date :

Jan 13, 2021

Anticipated Primary Completion Date :

Mar 23, 2023

Anticipated Study Completion Date :

Mar 23, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Extraocular muscle stretching arm	Procedure: Extraocular muscle stretching Extraocular muscle stretching to test its efficacy as a weakening procedure

Arm

Intervention/Treatment

Experimental: Extraocular muscle stretching arm

Procedure: Extraocular muscle stretching

Extraocular muscle stretching to test its efficacy as a weakening procedure

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UAM	Madrid		Spain	28029

Sponsors and Collaborators

Universidad Autonoma de Madrid

Investigators

Principal Investigator: Jaime Tejedor, MD, PhD, UAM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jaime Tejedor, Principal Investigator, Universidad Autonoma de Madrid

ClinicalTrials.gov Identifier:

NCT05778565

Other Study ID Numbers:

OFTEOM-0322

First Posted:

Mar 21, 2023

Last Update Posted:

Mar 21, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Strabismus

Study Results

No Results Posted as of Mar 21, 2023