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

March 11, 2020 updated by: Ahmed Awadein, Cairo University

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

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 Contact

Study Contact Backup

Study Locations

  • Egypt
      • Cairo, Egypt
        • Recruiting
        • Faculty of Medicine Cairo University
        • Contact:
        • Principal Investigator:
          • Ahmed Awadein, doctorate

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

2 years to 6 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor success rate
Time Frame: 6 months
Number of patients with orthophoria (8 PD exophoria to 4 PD esophoria)
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pattern strabismus
Time Frame: 6 months
Number of patients who develop pattern strabismus
6 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Study Chair: Ayman Elshiaty, MD, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ANTICIPATED)

April 1, 2020

Primary Completion (ANTICIPATED)

April 1, 2021

Study Completion (ANTICIPATED)

April 1, 2022

Study Registration Dates

First Submitted

April 18, 2015

First Submitted That Met QC Criteria

March 11, 2020

First Posted (ACTUAL)

March 16, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 16, 2020

Last Update Submitted That Met QC Criteria

March 11, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D-20-2020

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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