Extraocular Muscle Stretching as a Weakening Procedure

NCT ID: NCT05778565

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-13

Study Completion Date

2023-06-23

Brief Summary

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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

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Conditions

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Strabismus, Comitant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Extraocular muscle procedure
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Extraocular muscle stretching arm

Group Type EXPERIMENTAL

Extraocular muscle stretching

Intervention Type PROCEDURE

Extraocular muscle stretching to test its efficacy as a weakening procedure

Interventions

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Extraocular muscle stretching

Extraocular muscle stretching to test its efficacy as a weakening procedure

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Autonoma de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Jaime Tejedor

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaime Tejedor, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Universite Abdou Moumouni de Niamey, Niger

Locations

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UAM

Madrid, , Spain

Site Status

Countries

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Spain

References

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Tejedor J, Gutierrez-Carmona FJ. Extraocular Rectus Muscle Stretching as a Weakening Procedure. Ophthalmol Ther. 2023 Oct;12(5):2793-2800. doi: 10.1007/s40123-023-00756-3. Epub 2023 Jul 1.

Reference Type DERIVED
PMID: 37392274 (View on PubMed)

Other Identifiers

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OFTEOM-0322

Identifier Type: -

Identifier Source: org_study_id

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