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Comparing Adjustable Sutures Surgery

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ClinicalTrials.gov Identifier: NCT04617158
Recruitment Status : Recruiting
First Posted : November 5, 2020
Last Update Posted : January 26, 2022
Sponsor:
Information provided by (Responsible Party):
Sahar T A Abdelaziz, Minia University

Study Description
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Brief Summary:
Adjustable suture surgery will be done in patients with horizontal strabismus comparing the time of adjustment

Condition or disease Intervention/treatment Phase
Strabismus, Comitant Procedure: Adjustable strabismus surgery Not Applicable

Detailed Description:
Forty patients will be equally divided into two groups and time of adjustment of the suture will be compared as regards efficacy and pain tolerance
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison Between Immediate Versus Late Postoperative Adjustable Eye Muscle Surgery
Actual Study Start Date : February 1, 2020
Estimated Primary Completion Date : February 22, 2022
Estimated Study Completion Date : March 30, 2022
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Early adjustable suture surgery
Suture adjustment after 2 hours of surgery
 Procedure: Adjustable strabismus surgery
Adjustable surgery will be done using sliding nose technique using fornix approach
Active Comparator: Late adjustable suture surgery
Suture adjustment after 24 hours of surgery
 Procedure: Adjustable strabismus surgery
Adjustable surgery will be done using sliding nose technique using fornix approach


Outcome Measures
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Primary Outcome Measures :
  1. Alignment of the strabismus [ Time Frame: 3 months ]
    Percentage of patients with successful postoperative alignment using prism cover test for measurement


Eligibility Criteria
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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • More than 16 years old patients Comitant esodeviation and exodeviation 15-45 prism diopters Cooperative patients

Exclusion Criteria:

  • Patients with previous strabismus surgery Patients with oblique deviations
Contacts and Locations
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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): NCT04617158


Contacts
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Contact: Sahar TA Abdelaziz, MD 00201065716074 sahar.abdelrazek@mu.edu.eg

Locations
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Egypt
Faculty of Medicine- Minia University Recruiting
Minya, Egypt, 61111
Contact: Sahar TA Abdelaziz, MD    00201065716074    sahar.abdelrazek@mu.edu.eg   
Sponsors and Collaborators
Minia University
Investigators
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Principal Investigator: Sahar TA Abdelaziz, MD Faculty of Medicine, Minia University
More Information
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Responsible Party: Sahar T A Abdelaziz, Assistant Professor, Minia University
ClinicalTrials.gov Identifier: NCT04617158    
Other Study ID Numbers: Minia University 2020
First Posted: November 5, 2020    Key Record Dates
Last Update Posted: January 26, 2022
Last Verified: January 2022

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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
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases