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Bil. LR Rec. Using Standard Tables VS Reduced Numbers in Intermittent Exo. in Children Under 6

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04308538
Recruitment Status : Recruiting
First Posted : March 16, 2020
Last Update Posted : March 16, 2020
Sponsor:
Information provided by (Responsible Party):
Ahmed Awadein, Cairo University

Brief Summary:
comparing the motor alignment and the incidence of postoperative esotropia following the correction of intermittent exotropia in children below 7 years by bilateral lateral rectus recession using the standard recession tables postulated by Parks versus correction using a reduced recession by one millimeter

Condition or disease Intervention/treatment Phase
Alternating Exotropia Procedure: Standard Recession Procedure: Reduced Recession Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Bilateral Lateral Rectus Recession Using Standard Tables Versus Bilateral Lateral Rectus Recession Using Modified Reduced Numbers in Intermittent Exotropia in Children Less Than 6 Years Old
Estimated Study Start Date : April 1, 2020
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : April 2022

Arm Intervention/treatment
Active Comparator: Standard Recession
Bilateral lateral rectus muscle recession using standard tables stated by Parks.
Procedure: Standard Recession
Bilateral lateral rectus muscle recession will be performed through fornix approach using standard tables

Experimental: Reduced Recession
Bilateral lateral rectus muscle recession using reduced numbers by one millimeter than the standard tables.
Procedure: Reduced Recession
Bilateral lateral rectus muscle recession will be performed through fornix approach using reduced numbers




Primary Outcome Measures :
  1. Motor success rate [ Time Frame: 6 months ]
    Number of patients with orthophoria (8 PD exophoria to 4 PD esophoria)


Secondary Outcome Measures :
  1. Pattern strabismus [ Time Frame: 6 months ]
    Number of patients who develop pattern strabismus



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with poor control intermittent exotropia (where poor control is defined as having a Newcastle score of 3 or more). (9)
  • Basic, pseudo- divergence excess and divergence excess types are included.
  • If associated with amblyopia it should be corrected before the surgical correction (where the visual acuity will be assessed by the single crowded HOTV test using a commercial projector).

Exclusion Criteria:

  • Intermittent exotropia of the convergence insufficiency type.
  • Intermittent exotropia with angle of deviation greater than 50 prism diopters.
  • Patients with previous squint surgery.
  • Patients with secondary deviation due to a sensory lesion or neurological condition.

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): NCT04308538


Contacts
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Contact: Ahmed Awadein, MD +201223911743 ahmedawadein@yahoo.com
Contact: Dina Hassanein, MD +20 100 517 2781 drdhossam@yahoo.com

Locations
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Egypt
Faculty of Medicine Cairo university Recruiting
Cairo, Egypt
Contact: Ahmed Siam, Masters    1111447245 ext +20    dr_sheded@hotmail.com   
Principal Investigator: Ahmed Awadein, doctorate         
Sponsors and Collaborators
Cairo University
Investigators
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Study Chair: Ayman Elshiaty, MD Cairo University
Publications of Results:
Other Publications:
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Responsible Party: Ahmed Awadein, Prof.Ahmed Awadein, Cairo University
ClinicalTrials.gov Identifier: NCT04308538    
Other Study ID Numbers: D-20-2020
First Posted: March 16, 2020    Key Record Dates
Last Update Posted: March 16, 2020
Last Verified: March 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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Exotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases