NCT05778565

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 13, 2021

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 20, 2023

Completed
29 days until next milestone

First Posted

Study publicly available on registry

March 21, 2023

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 23, 2023

Completed
Last Updated

May 3, 2023

Status Verified

May 1, 2023

Enrollment Period

2.4 years

First QC Date

February 20, 2023

Last Update Submit

May 2, 2023

Conditions

Strabismus, Comitant

Outcome Measures

Primary Outcomes (1)

  • Distance deviation at 2 months after surgery

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

    2 months

Study Arms (1)

Extraocular muscle stretching arm

EXPERIMENTAL
Procedure: Extraocular muscle stretching

Interventions

Extraocular muscle stretchingPROCEDURE

Extraocular muscle stretching to test its efficacy as a weakening procedure

Extraocular muscle stretching arm

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with previous strabismus surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UAM

Madrid, 28029, Spain

Location

Related Publications (1)

  • 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.

    PMID: 37392274DERIVED

MeSH Terms

Conditions

Strabismus

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Jaime Tejedor, MD, PhD

    Universite Abdou Moumouni de Niamey, Niger

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Extraocular muscle procedure
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 20, 2023

First Posted

March 21, 2023

Study Start

January 13, 2021

Primary Completion

June 23, 2023

Study Completion

June 23, 2023

Last Updated

May 3, 2023

Record last verified: 2023-05

Locations

ES(1)