Lees Screen in Concomitant Strabismus | NCT04213053

Studies
Lees Screen in Concomitant Strabismus

NCT04213053

Sponsor

Minia University

Status

Unknown status

Last Update Posted

Mar 15, 2024Actual

Enrollment

24Estimated

Phase

Not Applicable

Conditions

Strabismus

Interventions

strabismus surgery

Countries

Egypt

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

Mar 2024

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2020Actual

Primary Completion Date

Oct 30, 2025Estimated

Completion Date

Dec 1, 2025Estimated

First Submitted Date

Dec 24, 2019

First Submission Date that Met QC Criteria

Dec 24, 2019

First Posted Date

Dec 30, 2019Actual

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

Mar 12, 2024

Last Update Posted Date

Mar 15, 2024Actual

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

Preoperative and postoperative Lees screen was done after concomitant horizontal strabismus surgery to detect any limitation in the field of operated muscle

Detailed Description

Preoperative and postoperative Lees screen was done for concomitant esotropia and exotropia patients to record any change in ocular motility as regards underaction or overaction in the operated extra ocular muscles

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

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Concomitant strabismus patients	Other	Horizontal strabismus surgery	Procedure: strabismus surgery

Interventions

Name	Type	Description	Arm Group Labels	Other Names
strabismus surgery	Procedure	Lees screen before and after concomitant strabismus surgery	Concomitant strabismus patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
postoperative Lees screen	detect any restriction in muscle field	3 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Concomitant esotropia
Concomitant exotropia
Above 10 years old patients

Exclusion Criteria:

Restrictive and paralytic strabismus
Previous strabismus surgery
Mental disability

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

10 Years

Maximum Age

40 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed F Ibrahiem, MD	Contact	00201064311860		mohamedfka@yahoo.com
Sahar T Abelaziz, MD	Contact	00201065716074		sahar.torky@yahoo.com

Overall Officials

Name	Affiliation	Role
Sahar TA Abdelaziz, MD	Minia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Medicine	Recruiting	Minya	Minya Governorate	61111	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D013285	Strabismus

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided