Comparing Adjustable Sutures Surgery

April 21, 2022 updated by: Sahar T A Abdelaziz, Minia University

Comparison Between Immediate Versus Late Postoperative Adjustable Eye Muscle Surgery

Adjustable suture surgery will be done in patients with horizontal strabismus comparing the time of adjustment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Minya, Egypt, 61111
        • Faculty of Medicine- Minia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Alignment of the strabismus
Time Frame: 3 months
Percentage of patients with successful postoperative alignment using prism cover test for measurement
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Minia University

Investigators

  • Principal Investigator: Sahar TA Abdelaziz, MD, Faculty of Medicine, Minia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2019

Primary Completion (Actual)

January 20, 2022

Study Completion (Actual)

April 10, 2022

Study Registration Dates

First Submitted

October 30, 2020

First Submitted That Met QC Criteria

November 4, 2020

First Posted (Actual)

November 5, 2020

Study Record Updates

Last Update Posted (Actual)

April 25, 2022

Last Update Submitted That Met QC Criteria

April 21, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Minia University 2020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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