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Extraocular Muscle Stretching as a Weakening Procedure (EOMS)

Primary Purpose

Strabismus, Comitant

Status

Active

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Extraocular muscle stretching

About this trial

This is an interventional treatment trial for Strabismus, Comitant

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Extraocular muscle stretching arm

Arm Description

Outcomes

Primary Outcome Measures

Distance deviation at 2 months after surgery

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05778565

First Posted

February 20, 2023

Last Updated

May 2, 2023

Sponsor

Universidad Autonoma de Madrid

1. Study Identification

Unique Protocol Identification Number

NCT05778565

Brief Title

Extraocular Muscle Stretching as a Weakening Procedure

Acronym

EOMS

Official Title

Stretching of an Extraocular Rectus Muscle as a Weakening Procedure

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 13, 2021 (Actual)

Primary Completion Date

June 23, 2023 (Anticipated)

Study Completion Date

June 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Universidad Autonoma de Madrid

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Strabismus, Comitant

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Extraocular muscle procedure

Masking

None (Open Label)

Allocation

N/A

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Extraocular muscle stretching arm

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Extraocular muscle stretching

Intervention Description

Extraocular muscle stretching to test its efficacy as a weakening procedure

Primary Outcome Measure Information:

Title

Distance deviation at 2 months after surgery

Description

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

Time Frame

2 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jaime Tejedor, MD, PhD

Organizational Affiliation

UAM

Official's Role

Principal Investigator

Facility Information:

Facility Name

UAM

City

Madrid

ZIP/Postal Code

28029

Country

Spain

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

When published

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Extraocular Muscle Stretching as a Weakening Procedure

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