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
About this trial
This is an interventional other trial for Exotropia
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.
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
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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