Study of Clinical Types and Surgical Out Come of Pediatric Exotropia

Study of Clinical Types and Surgical Out Come of Pediatic Exotropia

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

Study Overview

• Status: Not yet recruiting
• Conditions: Exotropia
• Intervention / Treatment: Procedure: Squint surgery

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:

1. Children will be examined after surgery on: 1st postoperative day, 1st week, 1st month, 3rd month, and 6 months postoperatively.
2. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Children with exotropia; squint surgery	Procedure: Squint surgery; Lateral rectus recession and /or medial rectus resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of children who become corrected post operatively	Results of exotropia surgeries in children in sohag university hospital	Six months
The number of children with post operative residual squint	Results of exotropia surgeries in children in sohag university hospital	Six months

Collaborators and Investigators

• Sponsor: Sohag University

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): January 31, 2022
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: September 5, 2021
• First Submitted That Met QC Criteria: October 21, 2021
• First Posted (Actual): October 22, 2021

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 21, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Ocular Motility Disorders; Strabismus; Exotropia
• Other Study ID Numbers: SAHashim

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No