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Status unknownNCT05089422Updated Oct 22, 2021

Study of Clinical Types and Surgical Out Come of Pediatric Exotropia

An interventional study of Squint surgery in Exotropia, sponsored by Sohag University. Status unknown. Open to participants aged Up to 15 Years. Per ClinicalTrials.gov, last updated 2021-10-22.

Sponsored by Sohag University · Not applicable, Interventional, and Other

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
Up to 15 Years
Sex
All
01

Study 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

Read the 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.
02

Conditions studied

  • Exotropia

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03

In context

Exotropia

58 studies on the registry are indexed under Exotropia; 13 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 49 interventional studies indexed under Exotropia.

Browse Exotropia studies →

Lead sponsor

Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.

Browse Sohag University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 15 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Children with exotropia

    squint surgery

    Procedure: Squint surgery

Interventions

  • ProcedureSquint surgery

    Lateral rectus recession and /or medial rectus resection

06

What researchers measure

Primary outcomes

  1. The number of children who become corrected post operatively

    Results of exotropia surgeries in children in sohag university hospital

    Time frame: Six months

  2. The number of children with post operative residual squint

    Results of exotropia surgeries in children in sohag university hospital

    Time frame: Six months

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2021; primary completion for Jan 2022, 2 months later.

Of 29 interventional studies with no phase under Exotropia, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 46. This study's planned 2 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 5, 2021
First posted
Oct 22, 2021
StartEst.
Nov 1, 2021
Primary completionEst.
Jan 31, 2022
CompletionEst.
Jul 30, 2022
Last update
Oct 22, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05089422
Lead sponsor
Sohag University
Responsible party
Sara Ali Hashim (ophthalmology resident doctor , principal investigator, Sohag University) — Principal investigator
First posted
Oct 22, 2021
Start date
Nov 1, 2021 (estimated)
Primary completion
Jan 31, 2022 (estimated)
Completion
Jul 30, 2022 (estimated)
Last update
Oct 22, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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