NCT04213053

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

December 24, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

July 1, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

5.3 years

First QC Date

December 24, 2019

Last Update Submit

March 12, 2024

Conditions

Strabismus

Outcome Measures

Primary Outcomes (1)

  • postoperative Lees screen

    detect any restriction in muscle field

    3 months

Study Arms (1)

Concomitant strabismus patients

OTHER

Horizontal strabismus surgery

Procedure: strabismus surgery

Interventions

strabismus surgeryPROCEDURE

Lees screen before and after concomitant strabismus surgery

Concomitant strabismus patients

Eligibility Criteria

Age10 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Concomitant esotropia
  • Concomitant exotropia
  • Above 10 years old patients

You may not qualify if:

  • Restrictive and paralytic strabismus
  • Previous strabismus surgery
  • Mental disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Minya, Minya Governorate, 61111, Egypt

RECRUITING

MeSH Terms

Conditions

Strabismus

Condition Hierarchy (Ancestors)

Ocular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Officials

  • Sahar TA Abdelaziz, MD

    Minia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed F Ibrahiem, MD

CONTACT

00201064311860mohamedfka@yahoo.com

Sahar T Abelaziz, MD

CONTACT

00201065716074sahar.torky@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: detect if there are any change in motility after concomitant horizontal muscle surgery
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 24, 2019

First Posted

December 30, 2019

Study Start

July 1, 2020

Primary Completion

October 30, 2025

Study Completion

December 1, 2025

Last Updated

March 15, 2024

Record last verified: 2024-03

Locations

EG(1)