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Lees Screen in Concomitant Strabismus

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ClinicalTrials.gov Identifier: NCT04213053
Recruitment Status : Recruiting
First Posted : December 30, 2019
Last Update Posted : June 11, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Farag Khalil Ibrahiem, Minia University

Tracking Information
First Submitted Date  ICMJE December 24, 2019
First Posted Date  ICMJE December 30, 2019
Last Update Posted Date June 11, 2020
Actual Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 24, 2019)
postoperative Lees screen [ Time Frame: 3 months ]
detect any restriction in muscle field
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lees Screen in Concomitant Strabismus
Official Title  ICMJE Changes in Range of Ocular Motility Following Horizontal Rectus Muscle Surgery in Concomitant Strabismus; a Quantitate Measurements Using Lees Screen
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
detect if there are any change in motility after concomitant horizontal muscle surgery
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Strabismus
Intervention  ICMJE Procedure: strabismus surgery
Lees screen before and after concomitant strabismus surgery
Study Arms  ICMJE Concomitant strabismus patients
Horizontal strabismus surgery
Intervention: Procedure: strabismus surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 24, 2019)
24
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2021
Estimated Primary Completion Date December 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Restrictive and paralytic strabismus
  • Previous strabismus surgery
  • Mental disability
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 40 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mohamed F Ibrahiem, MD 00201064311860 mohamedfka@yahoo.com
Contact: Sahar T Abelaziz, MD 00201065716074 sahar.torky@yahoo.com
Listed Location Countries  ICMJE Egypt
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04213053
Other Study ID Numbers  ICMJE Paediatric ophthalmology unit
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mohamed Farag Khalil Ibrahiem, Minia University
Study Sponsor  ICMJE Minia University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sahar TA Abdelaziz, MD Minia University
PRS Account Minia University
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP