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Study of Clinical Types and Surgical Out Come of Pediatric Exotropia

Sponsor
Sohag University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05089422
Collaborator
(none)
30
Enrollment
1
Arm
8.9
Anticipated Duration (Months)

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Procedure: Squint surgery
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Study of Clinical Types and Surgical Out Come of Pediatic Exotropia
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Jan 31, 2022
Anticipated Study Completion Date :
Jul 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Children with exotropia

squint surgery

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

Outcome Measures

Primary Outcome Measures

  1. The number of children who become corrected post operatively [Six months]

    Results of exotropia surgeries in children in sohag university hospital

  2. The number of children with post operative residual squint [Six months]

    Results of exotropia surgeries in children in sohag university hospital

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:

  2. Paralytic squint

  3. Consecutive exotropia

  4. Any neurological disorder

  5. History of previous squint surgery

  6. History of previous other ocular surgery (e.g. congenital cataract & glaucoma)

  7. Children who missed follow up.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Sohag University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sara Ali Hashim, ophthalmology resident doctor , principal investigator, Sohag University
ClinicalTrials.gov Identifier:
NCT05089422
Other Study ID Numbers:
  • SAHashim
First Posted:
Oct 22, 2021
Last Update Posted:
Oct 22, 2021
Last Verified:
Oct 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Exotropia

Study Results

No Results Posted as of Oct 22, 2021