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Basic Intermittent Exotropia and Risk Factors for Postoperative Overcorrection and Under Correction

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03153423
Recruitment Status : Completed
First Posted : May 15, 2017
Last Update Posted : February 20, 2020
Sponsor:
Information provided by (Responsible Party):
Mohamed Farag Khalil Ibrahiem, Minia University

Brief Summary:
To evaluate preoperative risk factors for overcorrection and undercorrection following surgery for basic intermittent exotropia such as axial length of the globe, refractive error, age and sex

Condition or disease Intervention/treatment Phase
Strabismus Procedure: Strabismus surgery Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 86 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Basic Intermittent Exotropia; is the Axial Length of the Globe One of the Prognostic Factors for Overcorrection and Undercorrection After Binocular Surgery
Actual Study Start Date : August 5, 2017
Actual Primary Completion Date : December 20, 2019
Actual Study Completion Date : January 14, 2020

Arm Intervention/treatment
Basic intermittent exotropia patients Procedure: Strabismus surgery
Recession and resection of horizontal extra ocular muscles




Primary Outcome Measures :
  1. Risk factors for postoperative overcorrections and under corrections [ Time Frame: 6 months ]
    as axial length of the globe, age, sex and refractive error



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Basic type intermittent exotropia

Exclusion Criteria:

  • previous strabismus surgery restrictive strabismus

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03153423


Locations
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Egypt
Faculty of medicine - Minia University
Minya, Egypt, 61111
Sponsors and Collaborators
Minia University
Investigators
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Principal Investigator: Mohamed F Ibrahiem, MD Minia University
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Responsible Party: Mohamed Farag Khalil Ibrahiem, Lecturer of ophthalmology, Minia University
ClinicalTrials.gov Identifier: NCT03153423    
Other Study ID Numbers: Minia2017
First Posted: May 15, 2017    Key Record Dates
Last Update Posted: February 20, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Strabismus
Exotropia
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases