Study of Clinical Types and Surgical Out Come of Pediatric Exotropia

Exotropia Clinical Trial

Official title:

Study of Clinical Types and Surgical Out Come of Pediatic Exotropia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05089422
• Other study ID #: SAHashim
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: October 2021
• Source: Sohag University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: July 30, 2022
• Est. primary completion date: January 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Exotropia

Intervention

Procedure:
• Squint surgery
Lateral rectus recession and /or medial rectus resection

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sohag University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of children who become corrected post operatively	Results of exotropia surgeries in children in sohag university hospital	Six months
Primary	The number of children with post operative residual squint	Results of exotropia surgeries in children in sohag university hospital	Six months