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Study of Clinical Types and Surgical Out Come of Pediatric Exotropia

Primary Purpose

Exotropia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Squint surgery
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Exotropia

Eligibility Criteria

undefined - 15 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Infants and children up to the age of 15 years.
  2. Primary Concomitant divergent squint (1ry concomitant exotropia)
  3. Candidate for surgical correction of squint

Exclusion Criteria:

  1. Children with:

    1. Paralytic squint
    2. Consecutive exotropia
    3. Any neurological disorder
    4. History of previous squint surgery
    5. History of previous other ocular surgery (e.g. congenital cataract & glaucoma)
  2. Children who missed follow up.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Children with exotropia

    Arm Description

    squint surgery

    Outcomes

    Primary Outcome Measures

    The number of children who become corrected post operatively
    Results of exotropia surgeries in children in sohag university hospital
    The number of children with post operative residual squint
    Results of exotropia surgeries in children in sohag university hospital

    Secondary Outcome Measures

    Full Information

    First Posted
    September 5, 2021
    Last Updated
    October 21, 2021
    Sponsor
    Sohag University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05089422
    Brief Title
    Study of Clinical Types and Surgical Out Come of Pediatric Exotropia
    Official Title
    Study of Clinical Types and Surgical Out Come of Pediatic Exotropia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 1, 2021 (Anticipated)
    Primary Completion Date
    January 31, 2022 (Anticipated)
    Study Completion Date
    July 30, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Sohag University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    study aiming to evaluate all children presented to strabismus clinic in ophthalmology department at sohag university hospital with divergent squint (exotropia) and to record surgical outcome of those who underwent strabismus surgery in our hospital
    Detailed Description
    A hospital-based, prospective, interventional study include infants and children up to the age of 15 years with Primary Concomitant divergent squint (1ry concomitant exotropia),Candidate for surgical correction of squint. Each patient will be subjected to Detailed history and Full preoperative ophthalmic & orthoptic evaluation including: Visual acuity , ocular motility in the 6 cardinal directions, Hirschberg test & angle of deviation. ,Cover test & prism cover test for distant & near fixation,Cycloplegic refraction , Anterior segment examination, fundus examination. _ post operative Follow-up regimen: Children will be examined after surgery on: 1st postoperative day, 1st week, 1st month, 3rd month, and 6 months postoperatively. The following will be recorded for each patient: Visual acuity, cover test, ocular motility testing, cover test and prism cover test, the degree of postoperative eye position, presence of over-correction or under-correction, and presence of any other complications.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Exotropia

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Children with exotropia
    Arm Type
    Experimental
    Arm Description
    squint surgery
    Intervention Type
    Procedure
    Intervention Name(s)
    Squint surgery
    Intervention Description
    Lateral rectus recession and /or medial rectus resection
    Primary Outcome Measure Information:
    Title
    The number of children who become corrected post operatively
    Description
    Results of exotropia surgeries in children in sohag university hospital
    Time Frame
    Six months
    Title
    The number of children with post operative residual squint
    Description
    Results of exotropia surgeries in children in sohag university hospital
    Time Frame
    Six months

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Infants and children up to the age of 15 years. Primary Concomitant divergent squint (1ry concomitant exotropia) Candidate for surgical correction of squint Exclusion Criteria: Children with: Paralytic squint Consecutive exotropia Any neurological disorder History of previous squint surgery History of previous other ocular surgery (e.g. congenital cataract & glaucoma) Children who missed follow up.

    12. IPD Sharing Statement

    Learn more about this trial

    Study of Clinical Types and Surgical Out Come of Pediatric Exotropia

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