Extraocular Muscle Stretching as a Weakening Procedure | NCT05778565

Studies
Extraocular Muscle Stretching as a Weakening Procedure

NCT05778565

Sponsor

Universidad Autonoma de Madrid

Status

Unknown status

Last Update Posted

May 3, 2023Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Strabismus, Comitant

Interventions

Extraocular muscle stretching

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 13, 2021Actual

Primary Completion Date

Jun 23, 2023Estimated

Completion Date

Jun 23, 2023Estimated

First Submitted Date

Feb 20, 2023

First Submission Date that Met QC Criteria

Mar 9, 2023

First Posted Date

Mar 21, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 2, 2023

Last Update Posted Date

May 3, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jaime Tejedor, Principal Investigator, Universidad Autonoma de MadridPrincipal Investigator

Lead Sponsor

Universidad Autonoma de MadridOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Extraocular muscle stretching arm	Experimental		Procedure: Extraocular muscle stretching

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Extraocular muscle stretching	Procedure	Extraocular muscle stretching to test its efficacy as a weakening procedure	Extraocular muscle stretching arm

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Distance deviation at 2 months after surgery	Distance deviation at 2 months after surgery (alternate prim and cover)	2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jaime Tejedor, MD, PhD	Universite Abdou Moumouni de Niamey, Niger	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UAM		Madrid		28029	Spain

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37392274	Derived	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.

ID	Term
D015835	Ocular Motility Disorders
D003389	Cranial Nerve Diseases
D009422	Nervous System Diseases
D005128	Eye Diseases