NCT05089422

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

October 22, 2021

Completed
10 days until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

October 22, 2021

Status Verified

October 1, 2021

Enrollment Period

3 months

First QC Date

September 5, 2021

Last Update Submit

October 21, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Children with exotropia

EXPERIMENTAL

squint surgery

Procedure: Squint surgery

Interventions

Lateral rectus recession and /or medial rectus resection

Children with exotropia

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Exotropia

Condition Hierarchy (Ancestors)

StrabismusOcular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ophthalmology resident doctor , principal investigator

Study Record Dates

First Submitted

September 5, 2021

First Posted

October 22, 2021

Study Start

November 1, 2021

Primary Completion

January 31, 2022

Study Completion

July 30, 2022

Last Updated

October 22, 2021

Record last verified: 2021-10